americanherbal pharmacopoeia - american college...

August 1999Editor: Roy Upton Herbalist

American Herbal Pharmacopoeiaand �herapeutic �ompendium

™

Associate Editor

Cathirose Petrone

Research Associates

Diana Swisher BA

Carey Siverly BS

Board of Directors

Roy Upton PresidentAmerican Herbal PharmacopoeiaSanta Cruz, CA

Michael McGuffin PresidentAmerican Herbal Products AssociationSilver Springs, MD

Joseph Pizzorno ND PresidentBastyr UniversityKenmore, WA

�stragalus �ootAstragalus membranaceus &Astragalus membranaceus var.mongholicusAnalytical, Quality Control, and Therapeutic Monograph

ISBN: 1-929425-04-X

© Copyright 1999 American Herbal Pharmacopoeia™Post Office Box 66809, Scotts Valley, CA 95067 USA

All rights reserved. No part of this monograph may be repro-duced, stored in a retrieval system, or transmitted in any formor by any means without written permission of the AmericanHerbal Pharmacopoeia™.

Literature retrieval provided by CCS Associates,Mountain View, CA

The AHP is a not-for-profit educational corporation 501(c)(3).

Medical DisclaimerThe information contained in this monograph represents asynthesis of the authoritative scientific and traditional data. Allefforts have been made to assure the accuracy of the informa-tion and findings presented. Those seeking to utilize botani-cals as part of a health care program should do so only underthe guidance of a qualified health care professional.

Statement of NonendorsementThe reporting on the use of proprietary products reflects stud-ies conducted with these preparations and is not meant to bean endorsement of these products.

Design & CompositionCloyce J WallSanta Cruz, CA

Cover PhotographsAstragalus membranaceus cultivated atTrout Lake Farm, Trout Lake, WAPhotograph © 1999 Roy Upton

Inset: courtesy of Bill BrevcortEast Earth Herbs, Eugene, OR

AuthorsHistory, Traditional ChineseMedicine SupplementCaylor Wadlington LAc OMDDenver, CO

BotanyAlison Graff PhDAmerican HerbalPharmacopoeia™

Santa Cruz, CA

MicroscopyElizabeth WilliamsonBSc PhD MRPharmS FLSCentre for PharmacognosyThe School of PharmacyUniversity of LondonLondon, EnglandSidney Sudberg LAc DCElan SudbergAlkemists PharmaceuticalsCosta Mesa, CA

Commercial Sources andHandling, Safety ProfileRoy Upton HerbalistAmerican HerbalPharmacopoeia™

Santa Cruz, CA

ConstituentsJeanette Roberts PhDAssistant ProfessorDepartment of MedicinalChemistryUniversity of UtahSalt Lake City, UT

Analytical MethodsSubstantiating LaboratoriesThin Layer Chromatography(TLC/HPTLC)Eike Reich PhDCAMAGMuttenz, SwitzerlandXi Ping Wang PhDGaia HerbsBrevard, NC

High Performance LiquidChromatography (HPLC)Prof Dr Hildebert WagnerHans MichlerInstitut für PharmazeutischeBiologieLudwig-Maximilians-UniversitätMunich, GermanyXi Ping Wang PhDGaia HerbsBrevard, NC

TherapeuticsPharmacokinetics andPharmacodynamicsMarilyn Barrett PhDPharmacognosy ConsultingServicesRedwood City, CA

Final ReviewersYingjie Chen PhDProfessor of PharmacologyShenyang PharmaceuticalUniversityLiaoning, ChinaBenjamin Lau MD PhDProfessor of Immunology,Microbiology, and MedicineLoma Linda UniversityLoma Linda, CAEric J Lien PhDProfessor of Pharmacy,Biomedicinal Chemistry, andPharmaceuticsUniversity of Southern CaliforniaLos Angeles, CAProf. Liu Geng TaoProfessor of PharmacologyDepartment of PharmacologyInstitute of Materia MedicaChinese Academy of MedicalSciencesBeijing, China

Review CommitteeDaniel Bensky DOSeattle, WAMark BlumenthalAmerican Botanical CouncilAustin, TXFrancis Brinker NDProgram in Integrative MedicineUniversity of ArizonaTucson, AZ

Bruce Canvasser NDNF Formulas Inc.Wilsonville, ORJohn Chen LAc PharmDCalifornia Association ofAcupuncture and OrientalMedicineHerbal Advisory Committee(Chair)Lotus HerbsLa Puente, CASteven Dentali PhD Senior Director of BotanicalScienceRexall SundownBoca Raton, FLAndrew Ellis LAc OMDSpring Wind Herbs Berkeley, CATrish Flaster MSBotanical LiaisonsBoulder, COSteven Foster Specialist inMedicinal and Aromatic PlantsFayetteville, ARAdriane Fugh-Berman MDNational Institutes of HealthWashington, DCStephen Fulder MA PhDConsultancy and Research onBiomedicineDoar Nah Oshret, IsraelConstance Grauds RPhAssociation for Natural MedicinePharmacistsSan Rafael, CASilena Heron NDAmerican Association ofNaturopathic PhysiciansSedona, AZChristopher Hobbs LAcInstitute for Natural ProductsResearchBonny Doon, CADavid Hoffmann MNIMHCalifornia Institute forIntegral StudiesSan Francisco, CAPing Qi Kang LAcAmerican College TraditionalChinese MedicineSan Francisco, CASL Lee PhDIntraTechTra IncColumbus, OH

Timo Lehto MSHaartman InstituteDepartment of Bacteriologyand ImmunologyUniversity of HelsinkiHelsinki, FinlandYu Juan Liang LAcAsia NaturalsSan Francisco, CADavid Lytle HerbalistMadris, ORDennis McKenna PhDMarine on St Croix MNAmanda McQuade CrawfordMNIMHOjai Center for PhytotherapyOjai, CALisa Meserole NDSeattle Healing ArtsSeattle, WADavid Molony LAc Dipl Ac CHAmerican Association of OrientalMedicineCatasauqua, PA Mary Mulry PhDFood Wise IncHygiene, COIchikawa Shinjin RPh (Japan)Yutaka PharmacyGifu, JapanClarissa Smith LAc HerbalistSeattle WAEd Smith HerbalistHerb PharmWilliams, ORThomas Sourisseau MSCabrillo CollegeAptos, CANaixin Hu-Tillotson LAcChrysalis Natural Medical CenterWilmington, DEAndrew Weil MDCollege of MedicineUniversity of ArizonaTucson, AZJeffrey C Yuen HerbalistAcupuncturistSwedish Institute IncNew York, NY

Amer i c an He rba l Pha r mac opo e i a ™ • A s t ra g a l u s Ro o t • Augu s t 1999 1

N O M E N C L A T U R E

Botanical NomenclatureAstragalus membranaceus (Fisch.) Bge., Astragalus mem-branaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao.

Botanical FamilyFabaceae

DefinitionAstragalus consists of the dried roots of Astragalus mem-branaceus (Fisch.) Bge. or Astragalus membranaceus(Fisch.) Bge. var. mongholicus (Bge.) Hsiao conforming tothe methods of identification provided.

Common NamesUnited States: Astragalus.China: Huang qi, bei qi (Mandarin);

beg kei, buck qi (Cantonese).Japan: Ogi.Korea: Hwanggi.

H I S T O R Y

The use of astragalus is thought to date back to the DivineHusbandman’s Classic of the Materia Medica [Shen-nongBen-cao Jing] which was ascribed to Shen-nong, a leg-endary figure in Chinese culture who is considered thefounder of agriculture and Chinese civilization itself. Thetrue origin of this work is largely lost in antiquity and isthought to represent the works of a collection of writers.The first work attributed to Shen-nong dates back to thefirst century AD while the codification of this work beganwith the writings of T’ao Hung-ching (AD 452-536). Inthis work astragalus was classified among the “superior”herbs [shang pin] which were among the most highlyrespected medicinals for their tonifying activity. This wasin contrast to the lower class of herbs which were used forthe treatment of disease. According to the writings of T’aoHung-ching, the upper class of herbs are “rulers...they con-trol the maintenance of life and correspond to heaven.They do not have a markedly medicinal effectiveness. Thetaking in large amounts or over a long period of time is notharmful to man. If one wishes to take the material weightfrom the body, to supplement the influences [circulatingin the body], and to prolong the years of life without aging”these herbs should be used (Unschuld 1986). Additionally,astragalus was said to be used for “hundreds of diseases inchildren.” (Yang 1998).

One account from the governmental period [chia-ching] (AD 1522-1566) reported that governmentalauthorities issued an order demanding delivery of astra-

galus. As the plant could not be found, a different plantwas substituted. This was considered to represent an infrac-tion of such magnitude that the physician who deliveredthe adulterant was almost beaten to death and was freedonly after payment of 30 to 40 pieces of gold (Unschuld1986).

Other uses ascribed to astragalus in ancient textsinclude its ability to heal chronic sores, expel pus, act as atonic to supplement deficiencies, and treat childhood ill-nesses. In the Ben-cao Gang-mu of Li Shi-zhen, one of themost important materia medicas of Chinese medical his-tory, astragalus is described as having “great repute as atonic, pectoral, and diuretic medicine” (Li 1578). In theworks of other Chinese authorities, including Sun Hua,Yuan Su, and Hao Gu, many uses of astragalus aredescribed. These include its ability to treat phlegm andcoughing, enhance breathing, prevent unnecessarygrowths, treat certain types of leukorrhea, arrest sponta-neous sweating, improve digestion, and treat various post-partum syndromes.

Traditionally, astragalus continues to be used as one ofthe primary tonifiers of Chinese herbal medicine. In mod-ern Chinese medicine it is widely used as an immunemodulator, especially to support immune health for vari-ous chronic degenerative diseases, and it is commonlyused as an adjunctive therapy to chemo- and radiationtherapy in cancer. Astragalus is listed in the pharma-copoeias of the People’s Republic of China and Japan.

Figure 1 Astragalus membranaceus.Chinese Color Illustrated Materia Medica 1996. RenMin Weisheng Publishing, Beijing

2 Amer i c an He rba l Pha r mac opo e i a ™ • A s t ra g a l u s Ro o t • Augu s t 1999

I D E N T I F I C A T I O N

Botanical IdentificationAstragalus membranaceus (Fisch.) Bge. var. mongholicus(Bge.) Hsiao. Herbacious perennial from taproot. Stem:25-80 cm; scandent; with sparse, appressed, white hairs.Leaf: Alternate, sessile, stipulate, odd-mono-pinnatelycompound, 3-7 cm long, leaflets in 12-18 pairs with termi-nal leaflet; each leaflet elliptic to oblong-obovate, 5-23 mmlong, 3-10 mm wide, glabrous above, white hairs below.Inflorescence: Axillary raceme, 4-5 cm long, peduncleerect, same length as or surpassing leaves, 2-22 dark yellowflowers. Flower: Calyx campanulate, 8-9 mm long, tube 3

Figure 2a Wild astragalus [huang qi] (unidentified species)growing in the Ba Shan Mountains, ChinaPhotograph ©1999 Roy Upton, Soquel, CA

Figure 2b Astragalus membranaceusPhotograph courtesy of Bill Brevoort East Earth Herb, Eugene, OR

times longer than linear-subulate lobes, petals 5, 18-20mm long, wings (lateral 2 petals) clawed, claw 1.5 timeslength of limb, lowermost 2 petals fused into 1 stronglykeeled petal, stamens 10, 9 fused, 1 free. Fruit: Legume,10-13 mm long, papery, glabrous. Seed: Reniform, 7-8 mmlong, dark brown.

Distribution: Sunny grassland, mountainsides. North-east-ern China (Foster and Chongxi 1992), Siberia, andCentral Mongolia (Scholz 1992).

Figure 2c Astragalus membranaceus cultivated Trout LakeFarms, Trout Lake, WAPhotograph ©1999 Roy Upton, Soquel, CA

Figure 2d Astragalus membranaceus cultivated in Anguo, ChinaPhotograph courtesy of Mark Taylor, Santa Cruz, CA and MayWay Corporation,Oakland, CA


Macroscopic IdentificationAstragalus is traded as whole or sliced roots. This materialvaries significantly in quality with whole roots generallyrepresenting the highest quality and the leftover shavingsfrom sliced roots representing the lowest quality (seeFigure 3). There are a variety of Astragalus spp. that aretraded. For macroscopic differentiation between speciessee Table 1.

Whole Root (Figure 3): Nearly cylindrical tap roots 30-100 cm long and 0.5-2 (rarely 2.5) cm in diameter, wider

at the top, cleaned and stripped of secondary rootlets; twist-ed near the crown. The outer surface is light grayish-yellowto yellowish-beige in color. Longitudinal wrinkles irregu-larly dispersed throughout and horizontal lenticel-like pat-terns are present. A cross section of the top portion of theroot reveals the following characteristics: a 2-3 mm-thicklight yellowish-white outer cortex; a light yellow xylemappearing as fine medullary rays in smaller roots andappearing as cracks in larger roots; a 1 mm-thick grayish-brown cambium; a pith that is brown but often unobserv-

a b c

d e f

g h i

Figure 3 a-i Commercial samples of astragalusa. Astragalus shavings (lowest quality). b. Astragalus sliced diagonally. c. Astragalus sliced horizontally. d. Astragalus sliced horizontally.e. Astragalus sliced horizontally. f. Whole astragalus roots (Chinese sample). g. Whole astragalus roots (Taiwanese sample). h. Whole hedysarumroots (adulterant-Taiwanese sample). i. Whole astragalus roots (organically cultivated in North America) (continued on next page).Samples courtesy of Asia Naturals, San Francisco, CA; Horizon Herbs, Williams, OR; Pacific Botanicals, Grants Pass, OR; Tai Sang Trading, San Francisco, CA; Lotus Herbs,La Puente, CA. Photographs by Joanne Thompson and Roy Upton, Santa Cruz, CA ©1999 American Herbal Pharmacopoeia™


Figure 3 j-n Commercial samples of astragalusj. Whole astragalus roots and powder (organically cultivated in North America; 6-year-old roots). k. Whole astragalus roots (organically cultivated inNorth America; 6-year-old roots). l. Whole astragalus roots partially pounded. m. Astragalus (cut and sifted). n. Different forms of astragalus.Samples courtesy of Asia Naturals, San Francisco, CA; Horizon Herbs, Williams, OR; Pacific Botanicals, Grants Pass, OR; Tai Sang Trading, San Francisco, CA; Lotus Herbs,La Puente, CA. Photographs by Joanne Thompson and Roy Upton, Santa Cruz, CA ©1999 American Herbal Pharmacopoeia™

j k l

m n

able. The thickness of the cortex is from one-third to one-half of the diameter of the xylem. The root is difficult tobreak; the fracture is fibrous (Japanese Pharmacopoeia1998). Aroma: Slight, starchy. Taste: Starchy, mildlysweet, and bean-like; sometimes accompanied by a slightacridness.

Sliced Root (Figure 3): There are four primary types ofslices traded in the United States. The most common areslices that are prepared by soaking and pressing or pound-ing. These are reminiscent of medical tongue depressorsand range in size from 1.5-3 cm wide by 8-18 cm long andfrom 0.6-4 cm thick. The second most common type ofsliced roots are those which are transversely or diagonallysliced from whole roots of varying size and are not other-wise processed. Less common are slices that are poundedand pressed paper thin and are often a deep yellow (sam-

ple not available). The lowest quality material is derivedfrom the shavings left over from the slicing process. Theseconsist of the very ends and outer edges of whole rootswhich are cut away to enhance the cosmetic appearance ofthe full slices. These slices are very thin and the outeredges are often black or beige. Internally, the color of thevarious sliced roots range from a pale beige to a pale ordeep yellow. The external bark of the sliced roots is a palegrayish-yellow, or pale to dark brown or black, with irregu-lar longitudinal wrinkles or furrows. Roots that are suppleand pliable are preferred. The roots are sometimes hardand difficult to break. Roots stored for prolonged periodsare brittle and snap easily. The fracture surface is fibrous orsplintery.

Powder: White to pale yellow; splintery and fibrous.


Table 1 Macroscopic characteristics of Astragalus spp.

A. membranaceus A. membranaceus A. floridus A. tongolensis A. chrysopterusvar. mongholicus

Diameter of 1.0-3.5 1.0-3.0 1.0-1.5 0.8-1.2 0.8-1.2midsection (cm)Color of surface Light yellow or Yellow or pinkish-yellow Yellowish-brown Dark brown or Light brown or

grayish-yellow or light brown reddish-brown grayish-brownSurface striations Bark hard with shallow Vertical striae relatively Bark relatively hard and Rough with scars, Bark loose with distinct

and irregular striae deep and straight with smooth with fine striae vertical striae twisted vertical striaeangular grooves

Texture Hard, pliable, breakable Hard, difficult to break Hard, difficult to break Hard, difficult to break Light and soft, easy to breakSection Bark white; wood light No peripheral brown ring Wood contains dense Wood contains loose Wood golden or orange with

yellow with a peripheral concentric alternating concentric alternating many cracksbrown ring yellow and white rings brown and yellow rings

Source: Li and others (1994).

Figure 4 Microscopic characteristics of Astragalus spp.1. Bundle of fibers showing truncated ends and adjacent parenchyma.2. Cork in surface view.3. Stone cells.4. Parenchyma of cortex.5. Xylem vessels; bordered-pitted and reticulately thickened.6. Bundles of fibers with medullary ray in sectional view.7. Starch.

Microscopic IdentificationWhole Root: When cut transversely, many rows of corkcells with 3-5 rows of collenchymatous cells making up thephelloderm are observable. The phloem rays are oftencurved and fissured along the outer part with fibers occur-ring in bundles. The walls are arranged alternately withsieve tube groups and are either thick or slightly lignified.Stone cells are occasionally visible near the phelloderm.The cambium forms a ring, and the xylem vessels areeither scattered singly or 2-3 vessels occur aggregated in agroup. Wood fibers are present among the vessels, andstarch grains are contained in the parenchymatous cells(Pharmacopoeia of the People’s Republic of China 1997).Fibers abundant, occurring in bundles or scattered; theseare colorless or orange-yellow, ranging from 6-22 µm indiameter, with characteristic thick walls, longitudinal fis-sures, and truncate or brush-like ends. Stone cells are iso-diametric or elongated, with thick, striated walls and sim-ple pits. Xylem mainly bordered-pitted, up to 224 µm indiameter, or occasionally reticulately thickened vessels.Cork thin-walled, several layers deep. Starch grains usual-ly simple, with visible linear or punctate hilum. Calciumoxalate absent.

A. membranaceus var. mongholicus may be differenti-ated by its fibers which rarely occur scattered and whosesecondary walls are often detached from the primary wall;the bordered-pitted vessels which are slightly smaller (upto 160 µm diameter); and fewer starch grains than A. mem-branaceus. For differentiation between species, particularattention should be paid to the arrangement and amountof the phloem fibers; the shape of the cambium; arrange-ment of the xylem vessels and fibers; and the presence orabsence of stone cells (Feng and others 1996). For com-plete comparative information of various species see Liand others 1994, Acta Pharmaceutica Sinica 29(11).Hedysarum spp. is sometimes traded interchangeably withastragalus. Hedysarum spp. reportedly can be identified byits fiber bundles which are surrounded by parenchymatouscells containing prisms of calcium oxalate 7-14 µm indiameter and up to 22 µm long.

Powder: Fibers abundant, occurring in bundles or scat-tered; these are colorless or orange-yellow, ranging from 6-22 µm in diameter, with characteristic thick walls, longi-tudinal fissures, and truncate or brush-like ends. Stonecells are isodiametric or elongated with thick, striated wallsand simple pits. Xylem mainly bordered-pitted, up to 224µm in diameter, or occasionally reticulately thickened ves-sels. Cork thin-walled, several layers deep. Starch grainsusually simple, with visible linear or punctate hilum.Calcium oxalate absent (Pharmacopoeia of the People’sRepublic of China 1997).


Table 2 Comparative microscopic characteristics of Astragalus spp.

A. membranaceus A. membranaceus A. floridus A. tongolensis A. chrysopterusvar. mongholicus

Thickness of bark 64± 57± 44± 38± 29±compared to radiusof root (µm)

T (µm)* 100-140 260-340 140-175 40-80 140-240L (µm)* 300-450 600-700 80-120 140-180 120-200H (µm)* 350-400 280-490 18-35 70-105 170-195T:L:H 1:3:3 1:2:1 6:4:1 1:3:2 1:1:1

Xylem: Shape of section Long and broad, fusiform Medium length, fusiform Thin and long, fusiform Short, fusiform Short and broad, fusiformShape of end Gradually narrow Gradually sharp Acute Slightly obtuse Convex

Height -number of cells 58± 27± 39± 17± 21±- µm 1200-2400 680-1700 600-2000 500-1000 550-1100Width - number of cells 6-7 4-5 2-4 3-4 5-6- µm 140-180 120-160 40-80 60-140 80-160Length of vessel (µm) 72-360 48-200 100-180 100-200 60-160Diameter of vessel (µm) 25-126 48-180 60-120 30-100 60-120

Distribution of xylem Scattered, more in Crowded mostly Many in rings, distance Many in rings, distance Many, scatteredfiber bundles inner than outer layers in the center between rings: 120-200 between rings: 440-520Diameter of starch 2-4-15 2-8-12 4-10-14 2-6-8 4-10-14grains (µm)

*T = the distance between cambium and the first layer of phloem fiber bundle

*L = length of dense phloem fiber bundle close to cambium

*H = the distance between two dense phloem fiber bundles close to cambium

Source: Li and others (1994).

Figure 5 Microscopic images of Astragalus membranaceusa. Bundle of fibers (400X).b. Cork in surface view (400X).c. Stone cells (400X).d. Parenchyma of cortex (400X).e. Xylem vessels (400X).f. Starch granules (1000X).g. Xylem parenchyma with conspicuous pith (800X).Microscopic images courtesy of Alkemists Pharmaceuticals, Costa Mesa, CA and Botanicals International,Long Beach, CA

a b c

d e f

g

50 µm


It is mistakenly believed that a deep yellow color, abroad width, and a sweet taste are signs of quality. Even rel-atively thin roots can be flattened wide (see Figure 3l) androots possessing a marked sweet taste have been treatedwith honey.

DryingIn China, astragalus roots are typically dried in the sun. Inthe United States, drying at 40 ˚C in a drying chamber for3 days has been reported and maintains the relative con-stituent profile of the whole root (see Figures 10f-i).

Figure 6 Qualitative grading of astragalusI. Superior Grade: Cylindrical with no rootlets; before processing,the length is no less than 30 cm long and the diameter, measured at themiddle point of the root, is from 2-2.5 cm. The surface color is whitish-yellow to brown with faint vertical wrinkles. The thickness of the bark,when viewing the cross section, is no less than that of the centralwoody part. It is relatively starchy and woolly with few fibers and isflexible. It is sweetish tasting with a distinct pea-like aroma. Afterchewing, not many remnants are left.

II. Median Grade: Cylindrical with no rootlets; before processing, thelength is no less than 20 cm and the diameter, measured at the middle,from 1-1.5 cm. The surface color is whitish-yellow to brown with obvi-ous vertical wrinkles. The thickness of the bark when viewing the crosssection is approximately one-third that of the central woody part. It issometimes starchy and less woolly than the superior grade. It has aweak sweetish taste and a pea-like aroma. After chewing, some rem-nants are left.

III. Inferior Grade: Rootlets are present; the diameter, measured atthe center, is approximately 1.0 cm or smaller. The surface color iswhitish-yellow to brown and has many obvious vertical wrinkles. Thethickness of the bark when viewing the cross section is smaller thanthat of the central woody part. It is relatively woody and inflexible. It isbland tasting with no aroma. When chewing, only fibers will be felt (Hu1995).Note: We were unable to obtain superior grade roots according to the parame-ters described above. Other authorities felt the diameter of the root should bemeasured at its widest point which is at the head of the root. Roots measuringalmost 2 cm in diameter at widest point were obtained. Even the highest qualityroots found on the American market may not entirely meet the specificationsoutlined. It has been estimated that less than 0.5% of all roots meet the superiorwidth specifications. Some authorities feel that roots over 1 cm in diameter areconsidered to be superior. Much emphasis is placed on the other qualitativeparameters as described and careful organoleptic analysis is required.

C O M M E R C I A L S O U R C E SA N D H A N D L I N G

The roots of A. membranaceus (Fisch.) Bge. and A. mem-branaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao areofficial in the 1997 edition of the Pharmacopoeia of thePeople’s Republic of China. Many other species of astra-galus are traded as huang qi. These include A. ernestiiComb., A. adsurgens Pallas., A. tongolensis Ulbr., A.tibetanus Benth. ex Bge., A. yunnanensis Franch., A.camptodontus Franch., A. aksuensis Bge., A. chrysopterusBge.

CollectionTraditionally, the roots of 4- to 5-year-old plants are pre-ferred and should be collected in the spring or autumn.Roots harvested in the autumn are reported to be superior(Ling and Yan 1994). After gathering, the roots are cleanedand graded according to size. Some roots are cut andsliced, others are dried whole.

Qualitative DifferentiationSeveral authoritative sources were consulted regarding thequalitative characteristics of astragalus. The roots fromHun-yuan county of Shanxi Province and the western partof Northeast China are considered to be authentic huangqi (Hu 1995). There are varying opinions as to the truequalitative markers of astragalus with most authoritiesreporting increased potency with increased root size. Incontrast to this opinion, comparative chemical analyses ofroots of varying age show that isoflavone and astragalosideconcentrations, constituents correlated with activity,decrease as the diameter of the roots increases (Anetai andothers 1994). In our samples, increasing age was correlat-ed with a decrease in concentration of most constituents(see Thin Layer Chromatography). Information regardingthe effect of aging on polysaccharide concentration wasnot available.

High quality roots should be dry, but supple, and resistsnapping. The outer surface should be relatively unwrin-kled. The roots should have a floury texture and a soliddeep yellow core, in contrast to material which is lacking acore or in which the core is black or pithy (Yen 1992).Varying cultivation and processing techniques also alterthe constituent profile and activity of the plant (seeCultivation and Processing).

According to Professor Shilin Hu, pharmacognosist ofthe Institute for Chinese Materia Medica in Beijing, astra-galus is graded according to the guidelines presented inFigure 6.

Slices: Sliced roots are very common in American trade.They vary in quality. Most are carefully prepared by soak-ing them in honey water and then pounding them flat,sometimes into tongue depressor-like slices, some pressedpaper thin. Some herb processors feel the concentration ofconstituents is reduced in the soaking process.


CultivationThe concentrations of astragalosides, isoflavones, and alco-hol-soluble constituents were assayed in astragalus grownon four different soils: sandy, red, ando, and brown.Astragalus grown in sandy and brown soil with a relativelyhigh concentration of phosphoric acid (5-15 kg/10 acres)yielded the highest concentration of isoflavones and hadthe best growth. This concentration increased as phospho-rus increased. Roots grown in the red and ando soils yield-ed the highest concentrations of astragalosides.Astragaloside content was also reportedly higher in themore slender roots. There was no difference in alcohol-sol-uble components between the different groups (Shibataand others 1996a). Polysaccharide concentration was notassessed.

Different constituent profiles were also observed withfour different types of plowing techniques: trencher, back-hoe, tractor, and no plowing before sowing. The longestroots (up to 80 cm with few lateral roots) were obtainedfrom the trencher plots, whereas in the other three plotsthe roots reached a length of 40 cm (with frequent lateralroots). Root elongation and lateral root development werecorrelated with soil hardness (penetration resistance); theharder soils (penetration resistance of more than 6-14kg/cm2) produced shorter roots with numerous lateralroots. Roots produced in the trencher plots contained highamounts of astragalosides (amounts not given) and rela-tively low amounts of isoflavonoids. The researchers con-cluded that astragalus should be grown in fields with gooddrainage, little water, and low penetration resistance inorder to produce longer roots with fewer lateral roots(Shibata and others 1996b). Other researchers reportedthat neither nitrogen nor potassium fertilizers affect growthor constituent yields (Anetai and others 1995).

Thirty-nine samples of astragalus root grown in differ-ent regions of China were tested for their effect on anti-body production in in vitro assays. Though complete dataare lacking, the authors reported the samples from Shanshiand Nei Mongol [Inner Mongolia] provinces effectivelyenhanced antibody production, whereas samples fromHsiashi had a weak effect. According to these researchers,activity was not found to be correlated with root diameter,concentration of isoflavonoids, or γ-aminobutyric acid(GABA) concentration, characteristics typically correlatedwith assessment of quality. The acidic polysaccharide frac-tion was shown to enhance antibody productions while theweakly acidic fraction suppressed it (Kajimura and others1997).

Domestic Supplies: Production of organically grownA. membranaceus has begun in the United States. Theseroots share the same morphological characteristics asChinese astragalus. Professor S Hu of the Beijing Instituteof Chinese Materia Medica conducted an organolepticanalysis of the material. His opinion was that the taprootsof the domestic material cultivated at one farm were not aswell developed as Chinese astragalus and that the plantswere overfertilized and overwatered. It should be notedthat astragalus is a member of the Fabaceae family ofwhich many species prefer growing in poor soil conditions.

However, chemical analysis of 2-, 4-, and 6-year-old domes-tically grown roots at a different location revealed a similarconstituent profile as authenticated A. membranaceus.Moreover, the 2-year old roots possessed the highest con-centration of astragaloside IV and all other detectablecompounds of all the samples analyzed. This analysisshowed a quantitative decrease in the primary compoundswith increased age (see Figure 10f-i). Most of the bands ofthe domestically grown material were more prominentthan the highest quality commercial Chinese astragalusobtained.

ProcessingSlices: The whole roots are soaked in water or a decoctionof Koelreuteria paniculata Lax., sliced, and pounded flat(Wagner and others 1997; Yen 1992). Processing withHoney: Astragalus can be either baked or stir-fried withhoney and water. The addition of heat and honey is a tra-ditional process employed to enhance the tonifying andnourishing aspects of the medicine (Pharmacopoeia of thePeople’s Republic of China 1997). However, processing inthis manner has been shown to decrease the macrophage-modulating activity of astragalus (Lau and others 1989).

AdulterationHedysarum polybotrys Hand.-Mazz. [hong qi, jin qi, mianhuang qi] is medicinally similar and is often traded inter-changeably as huang qi. It is produced in the Min Countyand surrounding areas in Gansu Province in China (Yen1992). Its surface color is reddish-brown. Like astragalus, itis woolly and fibrous with a sweetish taste and faint pea-like aroma. TLC analyses reveal some similarities withastragalus but show that it is lacking in astragaloside IV, theprimary compound used as an identifying marker. Thesefindings need to be confirmed through additional analyseswith multiple botanically authenticated specimens.According to the literature, Hedysarum is reported to con-tain some of the flavonoids of astragalus. It also containspolysaccharides which have been shown to stimulate anincrease in peritoneal macrophages at concentrations of500 mg/kg and, like A. membranaceus, has been reportedto possess hypotensive activity. Hedysarum vicioides Turcz.is also reported as an adulterant.

StorageRoots should be stored in a dry, cool area protected frommoisture, light, air, and insect infestation. Exposure to sun-light for as little as 30 minutes can bleach out the yellowcolor.

PreparationsIn traditional Chinese medicine (TCM), astragalus is mostoften used in combination with other herbs in soups, teas,pills, and extracts. In North America, astragalus is used incapsules, pills, tablets, and liquid extracts, both singularlyand in combination with other herbs. Specific data formaking the various preparations are lacking.


C O N S T I T U E N T S

The constituents most often associated with the activity ofastragalus are polysaccharides, triterpene glycosides,flavonoids, and isoflavonoids. The following constituentsare reported in the literature for A. membranaceus.

PolysaccharidesThe literature is quite confusing concerning the polysac-charide components of astragalus. Often mentioned are:astragalans I-III, AMon-S, AMem-P (Shimuzu and others1991), AH-1, AH-2 (Fang and others 1982; Morazzoni andBombardelli 1994; Shimuzu and others 1991; Tomodaand others 1992). These components are generallyreferred to as polysaccharides A-D or astragalans I-IV andcollectively as astragaloglucans. Astragalan I appears to becomposed of a mixture of D-glucose, D-galactose, and L-ara-binose with a molecular weight in the 36 kD range.Astragalans II and III are composed solely of D-glucoseresidues with an average molecular weight of 12.3 and36.3 kD, respectively. The glucose units appear to be pri-marily α-(1-4)-linked with periodic α-(1-6)-linked branch-es (Huang and others 1981, 1982).

Triterpene Glycosides (Aglycones and Glycosides) The triterpenoid components of astragalus are among themost widely studied chemically. A number of related com-pounds have been isolated from the plant including: astra-galosides I-VIII (He and Findlay 1991; Kitagawa and oth-ers 1983a, 1983b; Morazzoni and Bombardelli 1994;Wang and others 1987), acetylastragaloside I, isoastragalo-sides I-IV, agroastragalosides I-IV, astramembranins I andII, astramembragenin, astraiversianin, daucosterol, β-sitos-terol, dancosterin, lupenone, soysaponin (Morazzoni andBombardelli 1994).

The triterpene glycosides vary by the position, num-ber, and type of sugar residues at positions 3, 6, and 25.Several astragalosides are composed of a single xylopyra-nosyl substituent at the 3-position which may or may notbe acetylated. Others are composed of a disaccharide atthis position with a glucopyranosyl residue linked 1-2 tothe xylose. Astragaloside VIII appears to be unique in thatit possesses a trisaccharide substituent (3-O-α-L-rhamnopy-ranosyl(1-2)-β-D-xylopyranosyl(1-2)-β-D-glucuronopyra-nosyl) at position 3 (Kitagawa and others 1983c). All theastragalosides and close analogs possess the chemicallyreactive epoxide at the 9-10 position of the steroid nucleus(the pharmacological significance of this highly reactivestructural feature is not known, though the safety of astra-galus has been well established through empirical use andmodern toxicologic investigation (see Safety Profile).Triterpenoids designated as astragaloside A and B have alsobeen isolated (Cao and others 1983, 1985). The stereo-chemical structures of these two compounds are differentfrom those of astragalosides I-IV.

Figure 7 Astragaloglucan of Astragalus membranaceus

R1 R2 R3 R4 R5Astragaloside I -Ac -Ac -H -b-D-Glc -HAstragaloside III -β-D-Glc -H -H -H -HAstragaloside V -β-D-Glc -H -H -H -β-D-GlcAstragaloside VII -H -H -H -β-D-Glc -β-D-GlcAcetylastragaloside I -Ac -Ac -Ac -β-D-Glc -HIsoastragaloside I -Ac -H -Ac -β-D-Glc -HAgroastragaloside III -Ac -Ac -H -β-D-Glc -β-D-Glc

Figure 9 Flavonoid and isoflavonoid components of Astragalusmembranaceus

Figure 8b Astragalosides A and B

Figure 8a Triterpenoids of Astragalus membranaceus


A N A L Y T I C A L

Thin Layer Chromatography (TLC/HPTLC)Various TLC systems were compared including themethod of the Pharmacopoeia of the People’s Republic ofChina (1997). The method of the Chinese pharmacopoeiawas used as the basis for this analysis. The sample prepara-tion was simplified and the ratios of the solvents of themobile phase and derivatizing agents were modified toenhance reproducibility and performance.Note: The reference standard astragaloside IV used in the substantiationof this method was isolated by an American Herbal Pharmacopoeia™(AHP) participating laboratory (Gaia Herbs) and was confirmed bynuclear magnetic resonance analysis. Astragaloside IV was presumablychosen as the reference standard in order to differentiate astragalus fromhedysarum.

Sample PreparationIn an Erlenmeyer flask 1 g of powdered root is extractedwith 20 mL of a mixture of ethanol and water (57:43).Shake the flask several times. Filter and evaporate filtrateunder vacuum at 45 ˚C, leaving a concentrate. Removelipids from the concentrate by treating it with 5 mL of amixture of ethyl acetate and water (1:1). Remove the upperphase (ethyl acetate) and extract the remaining lowerphase (water) with two 2.5 mL portions of fresh ethylacetate. Discard the ethyl acetate layers. The aqueousphase is extracted 3 times with 5 mL portions of l-butanol.The combined l-butanol extracts are gently washed withthree 1 mL portions of water (water and butanol easily

form emulsions when agitated vigorously). l-butanol isremoved under vacuum and the residue is dissolved in 0.5mL of methanol. The solution is transferred to a smallsample vial. This is the test solution.Note: Samples of astragalus and hedysarum were run in order to pro-vide a differentiation between the two. Samples were provided by AsiaNaturals, San Francisco, CA; Horizon Herbs, Williams OR; LotusHerbs, La Puente, CA; Spring Wind Herbs, Berkeley, CA.

Standard PreparationAstragaloside IV. Prepare standard at a concentration of 1mg/mL in methanol. This is the standard solution.

Reagent PreparationSulfuric Acid Reagent:

While cooling with ice, carefully add 5 mL of sulfu-ric acid to 95 mL of cold methanol.

Anisaldehyde Reagent:While cooling with ice, 9 mL of sulfuric acid areadded carefully to a cold mixture of 85 mL methanoland 10 mL acetic acid. To this mixture 0.5 mL ofanisaldehyde are added.

Stability and Storage of PreparationsThe standard is stable at room temperature and is notphotosensitive.(continued on pg 12)

Isoflavonoids (Aglycones and Glycosides)Characteristic isoflavonoid constituents include:mucronulatol, isomucronulatol, demethoxyisoflavin (andnumerous methylated and glycosylated derivatives), andformononetin (Kim and Kim 1997; Lu and others 1984;Subarnas and others 1991a; Yu and Liu 1993). The

isoflavonoid content of various astragalus samples variesgreatly (see Table 3).

Flavonoids (Aglycones and Glycosides)Characteristic flavonoid components include: calycosin,kumatakenin, isoliquiritigenin, isorhamnetin, kaempferol,rhamnocitrin, and quercetin (Dungerdorzh and Petrenko1972; Dungerdorzh and others 1974; He and Wang 1990;Leung and Foster 1996; Wang and others 1983; Yu andLiu 1993).

Other Compounds3-hydroxy-2-methylpyridine, (-)—coriolic acid, (+)-lari-ciresinol, (-)-syringaresinol, lupenone (Subarnas and oth-ers 1991b). Amino acids: alanine, arginine, asparagine,aspartic acid, canavanine, GABA, glutamic acid, prolineand others (Liao 1992; Xiao and others 1984). Trace ele-ments: calcium, chromium (0.3-0.8 ppm), cobalt, copper(5-9 ppm), iron (94-694 ppm), magnesium (1108-1761ppm), manganese (8-52 ppm), molybdenum (0.1-10 ppm),potassium, rubidium (11-13 ppm), selenium (He andOuyang 1985), sodium, titanium, vanadium, zinc (11-23ppm) (Diao and others 1982; Hou and Hou 1990; Liao1992). Additional constituents: sucrose, betaine, choline,nicotinic acid, folic acid, linoleic acid, linolenic acid,palmitic acid (Kim and Kim 1997; Leung and Foster 1996;Wang and others 1983).

Table 3 Contents of isoflavonoids in various samples of astra-galus root

Isoflavonoid Content (µg/g)

Sample Habitat I II III IV V

1 China 110 25 82 220 1082 China 225 89 47 27 563 China 554 132 167 116 2774 China 366 55 108 299 1095 China 523 549 124 70 506 China 47 71 125 78 857 China 345 108 94 47 3558 China 355 35 215 315 1879 China 147 19 105 121 185

10 Korea 236 51 115 165 8011 Japan 296 201 92 124 1612 Japan 523 214 324 449 7913 Japan 383 223 337 467 77

Source: Katsura and Yamagishi (1987).


Figure 10a HPTLC of astragalus and hedysarum, UV 254; read left to rightLane 1: Astragalus (Chinese sample). Lane 2: Astragaloside IV. Lane 3: Astragalus (6-year-olddomestically cultivated root). Lane 4: Astragaloside IV. Lane 5: Hedysarum (Taiwanese sample).Close to the solvent front two very weak bands are visible in the astragalus sample. At the same posi-tion hedysarum shows one or two bands. There are three bands evenly spaced between 0.4 and 0.7in all samples. Of those bands, the middle is the strongest for astragalus and the lowest is strongestfor hedysarum. Astragalus shows a strong band at 0.15 whereas hedysarum has bands at 0.1 and 0.3.At this spectra, astragaloside IV is not visible.

Figure 10b HPTLC of astragalus and hedysarum, UV 366; read left to rightLane 1: Astragalus (Chinese sample). Lane 2: Astragaloside IV. Lane 3: Astragalus (6-year-olddomestically cultivated root). Lane 4: Astragaloside IV. Lane 5: Hedysarum (Taiwanese sample).The two bands close to the solvent front show blue fluorescence. In hedysarum the lower of the twobands is more intense. Hedysarum can be identified through the presence of a green band at 0.63. Atthis spectra, astragaloside IV is not visible.

Figure 10d HPTLC of astragalus and hedysarum, sulfuric acid reagent,UV 366; read left to rightLane 1: Astragalus (Chinese sample). Lane 2: Astragaloside IV. Lane 3: Astragalus (6-year-olddomestically cultivated root). Lane 4: Astragaloside IV. Lane 5: Hedysarum (Taiwanese sample).Three bands close to the solvent front show white fluorescence. In hedysarum the lowest of thesebands is most intense. At 0.7 there is an orange band below a white band in astragalus. In thehedysarum sample only the white band is present. In astragalus the bands between 0.4 and 0.7 showorange or brown fluorescence. Astragaloside IV has an orange band at 0.34. This band is observablein the astragalus sample and is lacking in the hedysarum sample. Hedysarum has two characteristicgreenish bands at 0.6 and another greenish band below 0.3. There is a strong dark band below 0.1 inall samples.

Figure 10e HPTLC of astragalus and hedysarum, anisaldehyde reagent, visible light; readleft to rightLane 1: Astragalus (Chinese sample). Lane 2: Astragaloside IV. Lane 3: Astragalus (6-year-olddomestically cultivated root). Lane 4: Astragaloside IV. Lane 5: Hedysarum (Taiwanese sample).Two or three bands close to the solvent front show a violet color. In hedysarum the lowest of thesebands is most intense. In the astragalus sample, two gray bands at 0.7 and several bands between0.4 and 0.7 are visible. The most characteristic of these is a pink to orange band at 0.63. In thehedysarum sample there is a single gray band at 0.7 and only a single dark violet band below 0.7.Astragaloside IV is visible as a dark band at 0.34. This band is present in astragalus and is lacking inhedysarum. There is a strong dark olive band below 0.1 in all samples.Note: A comparison of these findings with the TLC work of Wagner and others (1997) suggests that the prominentbands falling between Rf 0.34 (corresponding to astragaloside IV) and Rf 0.7 correspond to astragalosides I-III, theprimary saponins of astragalus. The bands above these are likely due to flavonoid glycosides and sapogenins.Since many of these reference standards are not commercially available, these compounds could not be defini-tively identified.

Figure 10c HPTLC of astragalus and hedysarum, sulfuric acid reagent, visible light; readleft to rightLane 1: Astragalus (Chinese sample). Lane 2: Astragaloside IV. Lane 3: Astragalus (6-year-olddomestically cultivated root). Lane 4: Astragaloside IV. Lane 5: Hedysarum (Taiwanese sample).The two bands close to the solvent front show violet to brown color. Astragalus shows three or fourviolet bands between 0.4 and 0.7. Astragaloside IV shows a violet band at 0.34. The astragalus sam-ple shows a violet band corresponding to astragaloside IV. In hedysarum two intense bands in thelower portion of the chromatogram and an intense violet band at 0.7 are seen. There is a very strongdark band at 0.1 in both samples.


Chromatographic ConditionsStationary Phase:

HPTLC plates 10 x 10 cm silica gel 60 with fluores-cence indicator (EM Science, Whatman, Macheryor equivalent).Note: HPTLC plates allow for better separation, sharper zones,reduced development time, and require less solvent consumptionper plate than conventional TLC plates. The method can also berun on standard TLC plates.

Mobile Phase:Chloroform:methanol:water (18:8:1).

Sample Application:3 µl volumes of test solution and standard areapplied each as an 8 mm band. Space bands 7 mmapart. Application position 8 mm from lower edge ofplate.

Development:10 x 10 cm Twin Trough Chambers (or equivalent),saturated (with filter paper) for 10 minutes, 5 mLdeveloping solvent per trough (or enough solvent to

have a level of 5 mm in chamber), developing dis-tance 70 mm from lower edge of plate. Dry platewith cold air for 5 minutes.

Detection:a) UV 254 nm.b) UV 366 nm.c) Sulfuric acid reagent: Immerse plate in reagent for1 second, dry in stream of cold air, heat to 130 ˚C for2-5 minutes. Examine plate in visible light.d) Examine derivatized plate under UV 366 nm.e) Anisaldehyde reagent: Immerse plate in reagentfor 1 second, dry in a stream of cold air, heat to 110˚C for 2 minutes. Examine plate in visible light.

Rf Values:Compare to the chromatograms below (see Figures10a-e).

Note: The 1997 edition of the Pharmacopoeia of the People’s Republic ofChina includes a quantitative TLC analysis and states that the astragalo-side IV content should be no less than 0.04% on a dried weight basis(Pharmacopoeia of the People’s Republic of China 1997). This quanti-tation was not substantiated by AHP collaborating laboratories.

Figures 10f-i HPTLC of various samples of astragalus (f: UV 254; g: UV 366; h: sulfuric acid reagent, visible light; i: sulfuric acid reagent,UV 366; j: anisaldehyde, visible light; read left to right Lane 1: Astragaloside IV. Lane 2: Astragalus (Chinese sample). Lane 3: Astragalus (Chinese sample). Lane 4: Astragalus (Chinese sample).Lane 5: Astragalus (Chinese sample). Lane 6: Astragalus (Chinese sample). Lane 7: Hedysarum (Taiwanese sample).Lane 8: Astragalus (Chinese sample). Lane 9: Astragaloside IV. Lane 10: Astragalus (2-year-old domestically cultivated root).Lane 11: Astragalus (4-year-old domestically cultivated root). Lane 12: Astragalus (6-year-old domestically cultivated root).Lane 13: Astragalus (domestically cultivated root; age unknown). Lane 14: Astragalus root with underground stem (domestically cultivated).Lane 15: Astragalus root (Chinese sample). Lane 16: Astragaloside IV.Note: All of the samples tested with the exception of the sample designated as hedysarum were traded as astragalus [huang qi].There are similarities in all of the samples tested. The sample in lane 2 is unique due to the presence of a strong yellow band which is due to at least two compounds co-eluting in this particular sample (underivatized, UV 366). The same band is present in samples of lanes 4-6 but is of weaker intensity and is likely due to a single com-pound. These samples, though traded as astragalus, may be hedysarum since the pink band characteristic of astragalus is missing and astragaloside IV is not present(anisaldehyde). Most of the bands of lane 3 are very faint or are lacking. Lanes 10-12 appear to indicate that the intensity of the bands, including the concentration ofastragaloside IV, decrease with increasing age of the root. The constituent profile of the root and underground stem sample of lane 14 appears weaker than the other cul-tivated samples.

f g

h i

j


High Performance LiquidChromatography (HPLC)The HPLC fingerprint analysis of Wagner and others(1997) was adopted. This method identifies bothflavonoids and saponins, two classes of compounds mostwidely associated with the activity of astragalus. Theflavonoid fingerprint is characterized by the isoflavonescalycosin-7-O-β-D-glucoside and calycosin, the isoflavonesisomucronulatol-7-O-β-D-glucoside and isomucronulatol,the pterocarpans 9-methoxy-nissolin-3-O-β-D-glucosideand 9-methoxy-nissolin, and the isoflavone formononetin.Astragalosides are eluted in the following order: astragalo-side VI, astragaloside V, astragaloside IV, astragaloside III,isoastragaloside II, astragaloside II, astragaloside I, andacetylastragaloside I. Using this method, the flavonoidselute first with retention times of 10 and 25 minutes andthe astragalosides elute later, from 25-50 minutes. Many ofthe reference standards are not commercially available.Because of the relatively low saponin content in astragalus,it is necessary to enrich the concentration of astragalosidesprior to analysis.

Sample Preparation20 g of coarsely ground astragalus is soxhlet extracted with200 mL methanol for 1 hour and filtered. The methanol isevaporated under vacuum and the viscous residue sus-pended in 25 mL hot water. The suspension is extractedtwice with water-saturated n-butanol in a separation fun-nel, first with 10 mL and then with 5 mL.

a) For flavonoids: 250 µL of the n-butanol phase (20 gdrug/15 mL n-BuOH) is applied to a C18-cartridge(SepPak) which has been pre-equilibrated and previouslyeluted with 1 mL methanol. Elute the SepPak with 0.5 mLfresh distilled water to give a butanol:water:eluate solutionfor HPLC analysis (the sapogenins are retained on the RP-C18 column). The eluate is filtered through a Milliporefiltration unit type HV 0.45 µm before injection into theHPLC.

b) For saponins: The total n-butanol phase (20 gdrug/15 mL) solvent is evaporated and the residue dis-solved in a minimal volume of MeOH (3 mL). This solu-tion is dropped into 50 mL ice-cooled ether:acetone (1:1)mixture. The resulting precipitate (containing the majorpart of the saponins) is separated by centrifugation, dis-solved in 1 mL hot MeOH, and injected into the HPLC.

Standard PreparationReference standards are generally not commercially avail-able. If available, prepare standards in stock solutions of 1mg/1 mL in MeOH (1%).

Stability and Storage of PreparationStability unknown. Use standard precautions for storage.

Chromatographic ConditionsApparatus:

Liquid chromatograph HP 1090 or equivalent.Photodiode array detector HP 1040 A or equivalent.

Column:Precolumn: LiChroCART 4-4 with LiChrospher 100RP 18 (5 µm) (Merck) or equivalent.Separation column: LiChroCART 125-4 withLiChrospher 100 RP 18 (5 µm) (Merck) or equivalent.

Mobile Phase:A) Distilled water (+1% 0.1 N-H3PO4).B) Acetonitrile (+1% 0.1 N-H3PO4).

Gradient:10% B in 5 minutes (isocratic).10% to 20% B in 10 minutes (linear).20% to 30% B in 20 minutes (linear).25% to 33% B in 30 minutes (linear).33% to 35% B in 40 minutes (linear).35% to 60% B in 50 minutes (linear).

Flow Rate:1.0 mL/minute.

Detection:200 nm.

Injection Volume:25 µl butanol:water eluate (concentration: 20 gdrug/15 mL n-BuOH). 25 µl reference solution(concentration: 1 mg /1 mL MeOH [0.1%]). 25 µlprecipitate solution (concentration: 100 mg/1 mLMeOH).

Run Time:50 minutes.

Elution Order:Flavonoids elute between 10 and 25 minutes.Astragalosides elute between 25 and 50 minutes. SeeTables 4 and 5 below for specific details.Note: Varying samples of authentically identified astragalus showalmost identical flavonoid profiles and differ only in quantities ofcalycosin and isomucronulatol-7-O-β-D-glucoside (Wagner andothers 1997).

Qualitative StandardsTotal Ash:

Not more than 5% (Pharmacopoeia of the People’sRepublic of China 1997).

Acid Insoluble Ash:Not more than 1% (Japanese Pharmacopoeia 1998;Pharmacopoeia of the People’s Republic of China1997).

Loss of Moisture Drying:Not more than 13% in 6 hours (JapanesePharmacopoeia 1998).

Moisture:Not more than 6% (Japanese Pharmacopoeia 1998).

Extractive Matter:Not less than 17% (Pharmacopoeia of the People’sRepublic of China 1997).


T H E R A P E U T I C S

PharmacokineticsStudies on the metabolism, distribution, and excretion ofastragalus preparations are not available.

PharmacodynamicsThe majority of research on astragalus has focused on itsimmunostimulatory activity and its seemingly remarkableability to restore the activity of a suppressed immune sys-tem. Both clinical trials and pharmacological data provideevidence for its usefulness in the prevention of the com-mon cold and as an adjunct to cancer therapies. There isalso evidence for benefit to the cardiovascular system withimprovement in clinical parameters associated with angi-na, congestive heart failure, and acute myocardial infarct,perhaps due to antioxidant activity. Its use in the treatmentof hepatitis in modern Chinese medicine is supported bythe demonstration of hepatoprotective activity in animalstudies.

Many of the pharmacological studies included in thissection were published in Chinese and as a result havebeen cited from translations, review articles, or Englishabstracts, rather than the complete primary literature.Numerous original studies were also reviewed. The reportsobtained from secondary sources are considered to beauthoritative, and the findings cited are consistent with theclinical use of astragalus in the United States and Asia.Several Chinese pharmacologists expert in the pharmacol-ogy of astragalus have reviewed this material to insure itsaccuracy. Nevertheless, a critical evaluation of much ofthe secondary literature was not conducted.

Immunomodulatory EffectsHuman Clinical StudiesA number of clinical studies have been reported regardingthe use of astragalus for colds and upper respiratory infec-tions. A prophylactic effect against the common cold wasreported in an epidemiological study in China involving1000 subjects. Administration of astragalus, given eitherorally or as a nasal spray, decreased the incidence of dis-ease and shortened the length of its course. Studies explor-ing this protective effect found that oral administration ofthe preparation to subjects for 2 weeks enhanced theinduction of interferon by peripheral white blood cells.Levels of IgA and IgG antibodies in nasal secretions werereported to be increased following 2 months of treatment(Chang and But 1987). The effect of astragalus on theinduction of interferon was studied in a placebo-controlledstudy involving 28 people. Fourteen volunteers were givenan extract equivalent to 8 g of dried root per day and 14were given placebos. Blood samples were drawn beforetreatment, then 2 weeks and 2 months after treatment.

Table 4 Retention times of the main peaks (flavonoids)

Peak Rt (min) Compound

1 12.0 Calycosin-7-O-β-D-glucoside2 20.2 9-methoxy-nissolin-3-O-β-D-glucoside3 22.2 Isomucronulatol-7-O-β-D-glucoside4 22.8 Calycosin5 33.5 Formononetin6 34.1 9-methoxy-nissolin7 36.1 Isomucronulatol

Table 5 Retention times of the main peaks (saponins)

Peak Rt (min) Compound

1 27.5 Astragaloside VI2 26.8 Astragaloside V3 32.5 Astragaloside IV4 33.5 Astragaloside III5 43.6 Isoastragaloside II6 45.8 Astragaloside II7 46.6 Astragaloside I8 48.0 Acetylastragaloside I

Source: The HPLC method was developed and substantiated in the laboratory of Prof DrHildebert Wagner, Munich, Germany. The method and chromatograms were reproduced fromChinese Drug Monographs and Analysis (available from the American Botanical Council,Austin, TX) with the permission of Verlag für Ganzheitliche Medizin Dr Erich Wühr GmbH,Bayer, Wald, Germany (Wagner and others 1997).

Figure 11 HPLC flavonoid fingerprint ofAstragalus membranaceus sample fromChina (Shanxi)

Figure 12 HPLC flavonoid finger-print of Astragalus membranaceusvar. mongholicus sample from China(Mongolia)

Figure 13 HPLC saponin fingerprint of Astragalusmongholicus sample from China (Mongolia)


Interferon production by leukocytes was statisticallyincreased after both time periods (P < 0.01) (Hou and oth-ers 1981). In another study, astragalus was shown to poten-tiate the effects of interferon (α-rIFN-1) in patients withchronic cervicitis (Qian and others 1990). No details ofthis study were available.

In China, astragalus is widely used in the treatment ofcancer, both as a primary treatment and as an adjunct toconventional therapies. It is most often combined withother similarly acting immune-enhancing botanicals. Anumber of randomized prospective clinical studies of can-cer patients were conducted using a combination of astra-galus and ligustrum Ligustrum lucidum (undisclosed quan-tities). Examples of these data are provided here as they arerepresentative of the use of astragalus in modern Chinesemedicine. However, these effects are considered to be dueto the cumulative effects of the two botanicals and cannotbe presumed to occur with astragalus alone.

According to a review article, breast cancer patientsgiven a combination of astragalus and ligustrum as anadjunct to irradiation treatments showed a statistically sig-nificant decrease in deaths from 1 in 2 to 1 in 10 (P <0.05). These authors cited an additional study in whichpatients with stage II and stage III cervical carcinoma whowere given the herbs as an adjunct to irradiation showed aslight, though not statistically significant, increase in sur-vival and disease-free state. In another study of patientswith advanced non-small-cell lung cancer, the effective-ness of conventional chemotherapy (chemotherapeuticregimen not reported) was compared to the effectiveness ofchemotherapy in conjunction with the same astragalus-ligustrum preparation. Those with squamous carcinoma ofthe lung showed a significant increase in mean survivaltime from 204 to 465 days, and those with adenocarcino-ma showed a less significant increase in survival from 192to 324 days (Morazzoni and Bombardelli 1994).

In another review, it was reported that 53 cases ofchronic leukopenia responded favorably to an astragalusextract (1:1; 2 mL daily intramuscularly [im] for 1-2weeks). Improvements in symptoms and white blood cellcounts were observed, but specific data were lacking(Chang and But 1987).

Animal StudiesProphylaxis against flu and modulation of endogenouslyproduced interferon has been reported in several animalstudies utilizing astragalus alone. Mice given a decoction(concentration not disclosed) of astragalus either orally oras nose drops were protected from infection with parain-fluenza virus type 1. Results from 28 experiments with1299 mice showed that while astragalus did not directlyinduce interferon it did promote the production of inter-feron in the mouse lung in response to parainfluenza virustype I (Chang and But 1987).

Potent immunorestorative activity was demonstratedin a xenogeneic graft-versus-host reaction (XGVHR - ameasure of T-cell functioning) after administration of

crude aqueous extract of astragalus. In this study, mononu-clear cells from humans were grafted into rats immuno-compromised with cyclophosphamide. The grafted cellssurvived, recognized host antigens, and reacted againstthem. The local reaction produced by mononuclear cellsfrom healthy donors covered an area of 82.8 ± 41.1 mm3.The reaction produced by cells from cancer patients wasless, covering an area of 18.2 ± 15.8 mm3. However, afterpretreatment of the cells from cancer patients with astra-galus extract (10 µg/mL), the reaction area increased to112.9 ± 94.2 mm3 (P < 0.01). The authors concluded theextract had restored to normal the immune response of themononuclear cells from the cancer patients (Sun and oth-ers 1983a).

The astragalus extract used in the above-cited studywas fractionated. An active fraction, identified as F3 (mol-ecular weight 20,000-25,000) along with its crude extractprecursor, fraction F7, and another crude extract deriva-tive, fraction F8, similarly increased local XGVHR as com-pared to untreated cells (P < 0.001) (Chu and others1988a).

In an extension of the above studies, the F3 fractionwas injected intravenously (iv) into rats immunocompro-mised with cyclophosphamide. Mononuclear cells fromhealthy donors were then grafted into the animals. Thesame fraction given to the rats at a dosage of 5.55 mg iv for8 days decreased the reaction size from 99.42 ± 9.2 mm3

to 39.8 ± 8.3 mm3 (P < 0.001). This reaction size was sim-ilar to that in rats not immunocompromised withcyclophosphamide (34.8 ± 5.7 mm3). The authors con-cluded that the F3 fraction reversed the immunosuppres-sive effect of cyclophosphamide (Chu and others 1988c).An additional study by the same primary investigator con-firmed these findings and reported that the fraction exhib-ited similar activity as the crude extract in rats (Chu andothers 1989).

The immunorestorative effects of astragalus were con-firmed by another group using a polysaccharide fractiondesignated as FB. In a local graft-versus-host reaction, thereaction of cells from normal healthy individuals increasedin area from 69.6 ± 20.8 mm3 to 148.9 ± 40.8 mm3 (P <0.001). The reaction of cells from 9 advanced-stage cancerpatients increased from what was defined as a negativereaction to that within the range of healthy individuals, forexample from 29.3 ± 9.5 mm3 to 137.2 ± 35.8 mm3 (P <0.001) (Wang 1989).

In another study, fraction F7, characterized as 4.6 mgcarbohydrate/mL, increased the number of antibody-pro-ducing cells in mice. The F7 fraction was effective wheninjected immediately before, or up to 1 day after, immu-nization with the antigen. Immunosuppression induced bycyclophosphamide (100 mg/kg intraperitoneal [ip]), aging(3 months versus 14 months), and irradiation (300 cGytotal body) was reversed by ip administration of 0.2 mL ofF7 into mice (Zhao and others 1990).

Another group of researchers isolated a polysaccharidefraction, containing astragalan I and II, from the roots of A.


mongholicus. An unspecified quantity of the fractionincreased the weight and number of cells in the spleens ofmice, stimulated the phagocytosis activity of peritonealmacrophages, and increased the agglutination of sheep redblood cells. Astragalan I, tested separately, increased theweight and number of spleen cells, but inhibited theagglutination of sheep red blood cells (Fang and others1982).

An acidic polysaccharide fraction derived from acrude hot water extract of A. mongholicus roots, designatedas AMon-S, enhanced the ability of tissue macrophages toengulf carbon particles. AMon-S, at 20 mg/kg ip and 40mg/kg ip increased phagocytosis (P < 0.001 and 0.005,respectively) in mice as measured by the carbon clearancetest (the ability of macrophages to engulf carbon particles)(Shimizu and others 1991). A similar glycan designated asAMem-P also showed activity in the carbon clearancemodel (Tomoda and others 1992).

A decoction of astragalus was studied for its ability tostimulate the generation of blood cells and platelets fromstem cells in the bone marrow of mature Kunming hybridmice. Proliferation and differentiation of pluripotent stemcells and granulocytic progenitor cells in the bone marrowwere enhanced by injection of 0.2 mL of the astragalusextract (equivalent to 0.2 g root) twice daily for 10 days.Increases in the bone marrow-nucleated cells, peripheralwhite blood cells, and granulocytes were also noted. It waspostulated that the effect was not directly on the hemopoi-etic cells, but rather through uncharacterized humoral fac-tor(s) which have colony-stimulating activity (Rou andRenfu 1983).

A combination of astragalus and ligustrum was shownto reduce tumor load in mice with implanted renal carci-noma. The preparation consisted of 500 µg of each botan-ical and was administered for 10 days. With an initialtumor load of 1 x 105 cells, there was 100% inhibition ofgrowth. With an initial tumor load of 2 x 105 cells, theamount of inhibition was reduced to 57% (Lau and others1994). In contrast to the aforementioned findings, thesame combination was found to be ineffective in prevent-ing cyclophosphamide-induced myelosuppression in rats(Khoo and Ang 1995).

In Vitro StudiesCrude aqueous extracts of astragalus (100 µg/mL) werereported to increase the proliferative response of mononu-clear cells derived from 14 cancer patients to stimulus byphytohemagglutinin (PHA) (P < 0.01) (Sun and others1983b). This finding was confirmed using the polysaccha-ride fraction designated as FB. Addition of 10 µg/mL FBincreased the blastogenic response of lymphocytesobtained from 18 normal individuals and 9 cancer patientsto suboptimal concentrations of PHA, concanavalin A, andpokeweed mitogen (P < 0.01 to 0.001). The increase inproliferative response was greater for lymphocytesobtained from normal individuals (Wang 1989). Similarincreases in the proliferative rate of mixed lymphocyte cul-

tures and the granulopexis of both macrophages and poly-morphonucleates were reported for astragalus polysaccha-rides (10 µg/mL) (Bombardelli and Pozzi 1991).

In another study, an aqueous astragalus extract (10 gpowder to 100 mL water) stimulated oxidative burst (anindicator of phagocytic activity) by a murine macrophagecell line (J774) in a dose-dependent manner. The dose-response curve was bell-shaped with significant enhance-ment beginning at 10 µg/mL and peak enhancement at100 µg/mL. Photon emissions increased from 9.7 x 106 to33 x 106 (P < 0.001) (Lau and others 1989; Lau and others1990). In further studies these researchers observed a rever-sal of tumor-associated macrophage suppression ofmacrophage chemiluminescent oxidative burst.Suppression induced by the addition of viable cells or cell-free extracts of urological neoplasms (murine cell carcino-ma and murine bladder tumor) were either completely orpartially reversed by extracts of astragalus and ligustrumeither alone or in combination (50-100 µg/mL)(Rittenhouse and others 1991).

Batches of crude root from pharmacies in Canada,Hong Kong, and the United States were also tested fortheir ability to stimulate macrophage activity. Hot waterextracts prepared from these samples were found to exhib-it a range of potencies, some being quite effective and oth-ers having no activity. Specific details were lacking.Honey-baked astragalus, a preparation used in traditionalChinese medicine, reportedly shows little to no effect onstimulating phagocytic activity in murine macrophage cellline (J774) (Lau and others 1989).

Astragalus was also studied for its ability to effect nat-ural killer (NK) cell activity using an enzyme-release assay.The NK cell activity of peripheral blood mononuclearcells (PBMC) from 28 patients with systemic lupus erythe-matosus (SLE) was increased after in vitro incubation withan undefined astragalus preparation. Low levels of NK cellactivity were correlated with disease activity. PBMC frompatients with SLE had significantly decreased NK cellactivity as compared to those from healthy donors. Theextent of stimulation by the astragalus preparation wasrelated to dose and the length of the preincubation period(Zhao 1992).

The effects of an astragalus preparation and α-inter-feron on NK cell cytotoxicity was studied using human gas-tric carcinoma cells as targets. Effector cells treated witheither astragalus or α-interferon demonstrated increasedcytotoxicity. When used together, cytotoxicity wasincreased 5- to 6-fold. When the target carcinoma cellswere pretreated with either astragalus or α-interferon, theywere protected from the NK cells. Cytotoxicity was againmarkedly increased when both the effector and target cellswere treated (Jin and others 1983).

The ability of the fraction F3 to potentiate the effectsof recombinant interleukin-2 (rIL-2) has been demonstrat-ed. Lymphokine-activated-killer cells (LAK) were treatedwith a combination of 55 µg carbohydrate/mL of fractionF3 and 100 units/mL of rIL-2. The combination therapy


produced the same amount of tumor-cell killing activity asthat generated by 1000 units/mL of rIL-2 on its own, thusshowing the astragalus fraction to elicit a 10-fold potentia-tion of rIL-2 in this in vitro model (Chu and others 1988b).These findings were confirmed in a follow-up study by thesame group of researchers using LAK cells from cancerand AIDS patients. In this study, the cytotoxicity of rIL-2(50 µg/mL) against Hs294t melanoma cell line of LAKcells was comparable to the activity of 500 µg/mL of rIL-2alone. With the combination, the effector-target cell ratiocould be reduced to one-half to obtain a level of cytotoxi-city that was equivalent to the use of rIL-2 alone.Additionally, F3 was also shown to increase the respon-siveness of peripheral blood lymphocytes that were noteffected by rIL-2. In this study, and in another by the sameresearchers, the authors concluded that the F3 fractionpotentiates the activity of LAK cells and allows for thereduction of rIL-2, thus minimizing the toxicity of rIL-2therapy (Chu and others 1990; Chu and others 1994).Almost identical findings (a 10-fold potentiation) werereported by other researchers who concluded astragalus iseffective in potentiating interleukin-2 generated LAK cellcytotoxicity in vitro (Wang and others 1992; Zhou and oth-ers 1995).

Astragalus was also found to enhance the secretion oftumor necrosis factor (TNF) from human PBMC. A poly-saccharide fraction (molecular weight 20,000-25,000)increased secretion of TNFα and TNFβ after isolation ofadherent and nonadherent mononuclear cells fromPBMC (Zhao and Kong 1993). Specific details regardingthe level of enhancement were lacking.

Cardiovascular EffectsHuman Clinical StudiesVarious cardioactive properties have been reported in theliterature. In one study, 92 patients with ischemic heart dis-ease were given an unidentified preparation of astragalus.Marked relief from angina pectoris and some improve-ments as measured by electrocardiogram (EKG) andimpedance cardiogram were reported. Improvement inthe EKG index was reported as 82.6%. Overall improve-ment was significant as compared to the control group (P< 0.05) (Li and others 1995). Similar improvement in car-diac performance was reported by other groups ofresearchers. In one study, 43 patients were hospitalizedwithin 36 hours of acute myocardial infarct. After adminis-tration of an astragalus preparation (undefined profile), theratio of pre-ejection period/left ventricular ejection time(PEP/LVET) was decreased, the antioxidant activity ofsuperoxide dismutase (SOD) of red blood cells wasincreased, and the lipid peroxidation (LPO) content ofplasma was reduced (Chen and others 1995). In anotherstudy, 20 patients with angina pectoris were given an unde-fined astragalus preparation. Cardiac output, as measuredby Doppler Echocardiogram (DEC), increased from 5.09± 0.21 to 5.95 ± 0.18 L/minute 2 weeks after administra-tion of astragalus (P < 0.01). In this study, no improvement

in left ventricular diastolic function and no inhibition ofadenosine triphosphate was observed (Lei and others1994). Intravenous administration of astragalus (undefinedpreparation) was also reported to significantly shorten theduration of ventricular late potentials in cardiac patients(39.8 ± 3.3 ms versus 44.5 ± 5.9 ms; P < 0.01) (Shi and oth-ers 1991).

Patients with congestive heart failure were treated for2 weeks with injections (unspecified amount) of astragalo-side IV, a primary triterpene of astragalus. Symptoms, suchas tightness in the chest, difficulty in breathing, and exer-cise capacity, improved. Radionuclide ventriculographyshowed that left ventricular modeling improved and leftventricular end-diastolic and left ventricular end-systolicvolume diminished significantly. The authors concludedthat astragaloside IV is an effective positively inotropicagent (Luo and others 1995).

The effect of astragalus on erythrocyte sodium contentand sodium transport in patients with coronary heart dis-ease was investigated. Intravenous administration of 24g/day of astragalus infused into a 5% glucose solution (250mL) significantly decreased erythrocyte sodium contentand significantly increased sodium pump activity (P <0.01) (Jin and Dai 1991).

Animal StudiesAstragalus saponins were reported to attenuate the scope ofmyocardial infarction and reduce infarct damage in anacute myocardial infarction model using anesthetizeddogs. The authors suggested that the protection resultedfrom inhibition of the production of free radicals (Lei andothers 1995).

In another study, a mild hypotensive effect occurredfollowing iv administration of an undefined astragaluspreparation to anesthetized rats. The magnitude ofhypotensive effect was reported to be qualitative and quan-titative although the exact decline in blood pressure wasnot reported. The researchers indicated that GABA was theconstituent responsible for the hypotensive activity(Hikino and others 1976).

Dose-dependent inotropic effects on coronary flowhave also been reported for saponin fractions of astragalus.Extracts were shown to exhibit a negative inotropic effecton the working hearts of rats at 30 µg/mL and a positiveinotropic effect at concentrations of 50-200 µg/mL. Theauthors suggested that the inotropic action was due to amodulation of Na+-K+-ATPase and worked in a mannersimilar to strophanthin K (0.75 µg/mL) (Wang and others1993; Zhong and others 1994).

Astragalus (1.0 g/day ip) was shown to ameliorateabnormal mRNA expressions in the aortic and renal cortexin aortocaval fistula-induced heart failure in rats. In thismodel, arginine vasopressin (AVP V1a) mRNA expressionlevels were decreased in the aortic arch and renal medullaand increased in the renal cortex; levels of mRNA expres-sions of AVP V2 receptor and aquaporin-2 increased in therenal cortex and decreased in the renal medulla. Theauthors concluded astragalus significantly improved the


renal reaction to atrial natriuretic peptide in rats with heartfailure (Ma and others 1998).

In Vitro StudiesAstragalus inhibited chemically-induced lipid peroxida-tion in isolated heart mitochondria by approximately 40%at a concentration of 2 mg dried root/mL mitochondrialsuspension (Hong and others 1994). A number ofisoflavonoids have been identified as having free radicalscavenging activity. This may account for some of the car-dioprotective effects attributed to astragalus (Yu and Liu1993). Astragalus polysaccharides were also reported toprevent free radical damage caused by xanthine/xanthineoxidase added to cultured cardiac cells (Sun and others1996).

The use of astragalus was reported to be superior tothe use of the calcium channel blocker verapamil and thecorticosteroid dexamethasone in the treatment of acuteviral myocarditis. All three agents decreased the calciuminflux across the myocardial plasma membrane in culturedneonatal rat heart cells after infection with coxsackie virusB-3. However, only the astragalus treatment inhibitedreplication of the virus in this in vitro assay (Guo and oth-ers 1996). Additional research suggests astragalus may beused as prophylaxis and treatment of acute coxsackie B-2virus-induced myocarditis (Yuan and others 1990). In onestudy, the effects of astragalus were assessed based onchanges in morphologic and electric activity of the cells.Rhythm, beating frequency, beating percentage, cardiaccellular damage, and cytopathic effects (CPE) were moni-tored every 24 hours after challenge; electric activitiesparameters were measured by conventional intracellularmicroelectrode technique. Administration of an undefinedastragalus preparation in the early period of infection wasreported to result in significant protective effects.

Astragalus has been reported to influence blood clot-ting through two different mechanisms. Human umbilicalvein endothelial cells (HUVECs) were pretreated with thesaponin astragaloside IV (0.01-100 µg/mL). Upregulationof tissue plasminogen activator (t-PA), which is involvedwith the breakdown of freshly formed clots (within the first4 hours), and a downregulation of plasminogen activatorinhibitor I (PAI-1), a potent inhibitor of t-PA, was observed.The clinical relevance of this, if any, is not known sincethis activity is not consistent with the traditional or modernuse of astragalus (Zhang and others 1997).

Hepatoprotective EffectsHuman Clinical StudiesIn China, astragalus is widely used in the treatment ofchronic hepatitis. According to a review article, elevatedserum levels of glutamate pyruvate transaminase (SGPT)were reported to return to normal, and symptoms associat-ed with the disease subsided within 1-2 months of treat-ment with an unspecified astragalus preparation (Tang andEisenbrand 1992). In another report, an aggregate effec-

tive rate of 85.7% (significantly effective rate 61.2%) wasobserved in 49 cases of chronic hepatitis. Normalization ofGPT levels was observed in 80% of the responsive patientswithin 1-2 months of treatment with an undefinedinjectable astragalus preparation (Chang and But 1987).More detailed data regarding these findings were not avail-able. Positive effects of oral administration of astragaluspolysaccharides for treatment of hepatitis were reported bya group of researchers who demonstrated enhanced inter-feron production in a manner similar to that demonstratedin in vitro studies (Zhang and others 1995).

Animal StudiesIn one study, oral administration of an ethanol extract ofastragalus reportedly prevented hepatic injury induced bystilbenemide, a hepatotoxic chemotherapeutic agent.Mice given 3 g/kg/day for 11 days had significantlyreduced SGPT levels. Histological changes in hepatic tis-sue, including fatty infiltration, vacuolar degeneration, andhepatocellular necrosis, were also reduced (Zhang andothers 1990).

In another study, fractionated saponins (ASI and SK)isolated from A. membranaceus Bge. and A. sieversianusPull., respectively, were shown to exhibit marked hepato-protective effects against liver damage induced by carbontetrachloride (CCl4), Escherichia coliform endotoxin, D-galactosamine, and acetaminophen in mice. The saponinswere shown to inhibit the elevation of SGPT levels,decrease malondialdehyde (MDA) content, and increaseglutathione (GSH) concentration in mouse livers. In addi-tion, the level of microsomal cytochrome P-450 in all micegiven the saponin fractions was significantly increased.The same findings were observed using primary culturedrat hepatocytes. The authors believed this activity was dueeither to antioxidant or immunomodulating activity(Zhang and others 1992).

In Vitro StudiesA single study exploring the possible effects of astragalus inthe treatment of hepatitis B reported significant inhibitionof viral protein expression and little effect on viral DNAsynthesis (Fan and others 1996). No additional data regard-ing this study were available.

Antiviral EffectsAnimal StudiesAstragalus (250 mg/kg/day for 5 days) in combination withacyclovir (50 mg/kg/day for 5 days) was tested againstHerpes Simplex Virus type-1 (HSV-1). The mortality ofHSV-1 infected mice was reduced by 46.88% in thosetreated with the combination therapy. When treated withastragalus or acyclovir alone, reduction in mortality was34.38 and 21.88%, respectively. In addition, the mean sur-


vival time was extended by 6.16 days with the combinedtherapy as compared to 4.39 and 2.37 days with the astra-galus and acyclovir, respectively (Zuo and others 1995).

In Vitro StudiesOne study on the effects of astragalus on a cold virus foundthat a 0.3% astragalus solution increased the cytopathicinhibitory effects of interferon α2b against rhinovirus type14 in WI-38, MRC-5, and 2BC human diploid cell cul-tures by 2.4 times (Zhang and others 1996). No additionaldata regarding this study were available.

Antioxidant EffectsAnimal and In Vitro StudiesThe antioxidant potential of components of astragalus hasbeen examined in a series of studies. The findings reportedhere are in addition to the antioxidant activities cited pre-viously in the review of the cardiovascular and hepatopro-tective effects of astragalus. The models used included pro-duction of luminol chemiluminescence by xanthine/xan-thine-oxidase (Xan/Xo), PMA-stimulated polymorphonu-clear leukocytes (PMNs), and hydrogen peroxide ion-induced lipid peroxidation of rat liver homogenate.Flavonoid and saponin extracts were reported to inhibitproduction of free radicals in all three models. A polysac-charide extract caused a slight inhibition of Xan/Xo emit-ted chemiluminescence, but it increased the respiratoryburst of PMA-stimulated PMNs and lipid peroxidation(Wang and others 1994). In a further study, flavonoid andsaponin extracts were reported to inhibit lipid peroxidationin purified human erythrocyte membranes stimulated byoxygen, peroxide, and ultraviolet irradiation (Wang andothers 1996a). Astragalosides VI, IV, and III were active inthe Xan/Xo model with the LC50 values cited as 11, 50,and 80 µg/mL, respectively (Liu and others 1991).Calycosin, an isoflavone isolated from the roots of astra-galus, was found to inhibit lecithin peroxidation inducedby hemoglobin and hydrogen peroxide with an IC50 of23.5 µM. This activity was greater than that of both ethyl-enediaminetetra-acetic acid (EDTA) (IC50 191.5 µM) andα-tocopherol (IC50 2.6 mM) (Toda and Shirataki 1998).

A flavonoid-rich astragalus preparation was reported toprotect DNA in V79 cells against damage by γ-irradiationor hydroxyl radicals at concentrations from 0.6-1.2 mg/mL(Wang and others 1995a, 1995b). Although these concen-trations are quite high, this group explored the possibilitythat this flavonoid mixture might be effective in protectingtissue from free radical damage during radiotherapy treat-ment of inoperative lung cancer (Wang and others 1996b).

Other EffectsIn vitro antibacterial activity of astragalus has been report-ed against a wide spectrum of bacteriae, including Bacillusanthracis, B. subtilis, Corynebacterium diphtheriae, C.pseudodiphtheriae, Diplococcus pneumoniae, Shigella shi-gae, Staphylococcus aureus, S. citreus, and S. hemolyticus.

No information about the preparation used was reported(Chang and But 1987).

In an attempt to identify Chinese medicinal herbs thatmight improve human sperm motility, water extracts of 18herbs were screened with a trans-membrane migrationmethod. The method measures the percentage of spermthat moves across the 5 µm pores of a nucleopore mem-brane from a semen-extract mixture into phosphatebuffered saline during incubation for 2 hours. Astragalus,at a concentration of 10 mg/mL, was the only herb of the18 tested shown to increase sperm motility when added toboth washed and unwashed fractions of human sperm(Hong and others 1992).

In a mouse model for senility, which involved inhala-tion of ozone and resultant induction of free radicals,administration of astragalus restored the balance of theintestinal flora (Yan and others 1995).

Astragalus root was reported to significantly lowerblood sugar levels in streptozotocin-induced diabetic rats(Park and others 1997).

ConclusionEvidence to support the oral administration of astragalusfor treatment of colds, upper respiratory infections, and asan adjunct to cancer therapies comes from its apparentremarkable ability to restore the functioning of a sup-pressed immune system. Xenogeneic graft-versus-hostexperiments have demonstrated the ability of astragaluspolysaccharides to restore the responsiveness of mononu-clear cells obtained from cancer patients. A corroboratingin vitro study demonstrated reversal of suppression ofmacrophage function caused by either tumor cells or cell-free extracts.

Restoration of immune function was also demonstrat-ed in animal models of immunosuppression induced bycycloposphamide, aging, or irradiation. Other studiesreport general immune stimulation including: increasedstem cell generation of blood cells and platelets, increasedlymphocyte proliferation, increased numbers of antibody-producing cells, increased numbers of spleen cells, stimu-lation of phagocytic activity by macrophages and leuko-cytes, and increased cytotoxicity by natural killer cells.

The benefits of astragalus to cardiovascular healthwith relief from angina, congestive heart failure, andimprovement in clinical parameters following acutemyocardial infarct are demonstrated. Cardiovascular bene-fits may be due in part to antioxidant properties of astra-galus preparations. It is important to note here that, in bothclinical and animal studies, astragalus was administered byinjection which may preclude application of these findingsto dietary supplement products. Animal studies demon-strating protection against hepatotoxic agents support themodern clinical use of the herb for liver diseases.

From the studies cited here it is evident that astragaluspreparations have significant therapeutic potential. More


studies are warranted, especially human clinical trialsexploring the possible benefits of astragalus to cancerpatients and immunocompromised individuals.

ActionsImmunostimulant (Chu and others 1988a, 1988b; Houand others 1981; Jin and others 1983; Sun and others1983a, 1983b), anticarcinogenic (Lau and others 1994),antiviral (Guo and others 1996; Zuo and others 1995),antioxidant (Hong and others 1994; Wang and others1996a, 1996b; Yu and Liu 1993), hepatoprotective (Zhangand others 1990; Zhang and others 1992), mild hypoten-sive (Hikino and others 1976).

IndicationsAstragalus is most commonly used as a general tonic andspecifically for immune enhancement. It has been used totreat the common cold and other upper respiratory tractinfections (Hou and others 1981), and it is commonly usedto enhance immune resistance in those experiencingrecurring upper respiratory infections. Astragalus potenti-ates rIL-2 (Chu and others 1988b) and α-rIFN-1 and -2immunotherapy (Hou and others 1981; Qian and others1990) and by lowering the therapeutic thresholds, canreduce the side effects normally associated with these ther-apies (Chu and others 1988b). It is useful as a comple-mentary treatment during chemotherapy, radiation thera-py, and immune deficiency syndromes (Rou and Renfu1983; Sun and others 1983a, 1983b).

In traditional Chinese medicine and Western clinicalherbal medicine, astragalus is most commonly used incombination with other botanicals and is very seldom usedas a single agent. Pharmacological research of astragalus incombination with ligustrum provides evidence for activityagainst cancers of the breast, cervix, and lung. Astragalushas been shown to support hematopoiesis which can lessenside effects and reduce the immunosuppression common-ly caused by chemotherapy and radiation therapies for can-cer (Rou and Renfu 1983; Zhao and others 1990).

Substantiated Structure and Function ClaimSupports immune function, enhances macrophage activi-ty (Hou and others 1981; Shimizu and others 1991; Sunand others 1983a; Tomoda and others 1992).

DosagesPowder:

9-30 g daily (Pharmacopoeia of the People’s Republicof China 1997). In serious conditions, 30-60 g daily(Bensky and others 1993). According to the findingsof one group of researchers, the optimal dosage forenhancement of macrophage activity is 4-7 g dailyfor a 79 kg human* (Lau and others 1990).

Decoction: 0.5-1 L daily (up to 120 g of whole root/L of water).

Use in Formulas: 1.5-9 g (Bensky and Barolet 1990; see TCMSupplement).

Soup: Approximately 30 g/3.5 L of soup (simmer with otherfood ingredients).

*Lau and others found astragalus to possess an inverted-U dose responsecurve with lower dosages eliciting significant enhancement ofmacrophage activity while larger doses had no effect or were immuno-suppressive. These researchers suggest that dosages in excess of 28 g perday should be avoided (Lau and others 1990).

S A F E T Y P R O F I L E

Classification of the American HerbalProducts AssociationClass 1: Herbs that can be safely consumed when usedappropriately (McGuffin and others 1997).

Side Effects None cited in the literature.

Contraindications None cited in the literature (see TCM Supplement).

Interactions Potentiates the effects of acyclovir (Zuo and others 1995),rIL-2 (Chu and others 1988b), and α-rIFN-1 and -2 thera-pies (Hou and others 1981; Qian and others 1990). May beincompatible with immunosuppressive agents.

Pregnancy, Mutagenicity, andReproductive ToxicitySpecific data are lacking. According to one report, astra-galus is reported to have no mutagenic effects (Wagner andothers 1997).

LactationSpecific data are lacking. Based on a review of the avail-able pharmacologic and toxicologic literature, no limita-tion is to be expected.

CarcinogenicitySpecific data are lacking.

Influence on DrivingSpecific data are lacking. Based on the available pharma-cologic and toxicologic literature, no limitation is to beexpected.

PrecautionsMay not be appropriate for the treatment of autoimmunediseases or following organ transplantation. Since


immunostimulating polysaccharides may stimulate hista-mine release, allergic symptoms may be aggravated by theuse of astragalus.

OverdoseSpecific data are lacking.

Treatment of OverdoseSpecific data are lacking.

ToxicologyInformation on the toxicologic profile of astragalus wasreviewed from the available English language literatureand is as follows. A crude astragalus extract, prepared byreflux of 100 g coarsely ground root for 6 hours with 1000mL distilled water and concentrated to 100 mL by rotaryevaporation, was administered to rats by lavage at a dosageequivalent to 75-100 g/kg. In this model, no toxicity wasreported (Chang and But 1987; Wagner and others 1997).Injection of 50 g/kg ip to mice reportedly elicited no sig-nificant toxic reactions though prostration, paralysis, dysp-

nea, cyanosis, and in some animals, contracture of theextremities, were observed before the death of the animals.The LD50 in mice is reported to be approximately 40 g/kgip (Chang and But 1987). Specific fractions show no or lit-tle toxicity (Chu and others 1988b).

I N T E R N A T I O N A L S T A T U S

United States: Regulated as a dietary supplement.China: Listed in the 1997 Pharmacopoeia of the

People’s Republic of China (see TCMSupplement for indications).

Japan: Listed in the 1986 JapanesePharmacopoeia XI (Wagner and others1997). Ingredient in Kampo medicines(Tsumura 1991). Injectable preparationsare regulated under the PharmaceuticalAffairs Law.

Taiwan: Available with and without a prescription.

22 Amer i c an He rba l Pha r mac opo e i a ™ • A s t ra g a l u s Ro o t • TCM Supp l emen t • Augu s t 1999

�stragalus �oot

T H E R A P E U T I C S

Taste and properties: Sweet, slightly warm.Channels of entry: Lung, spleen.

Spleen Qi TonificationAstragalus supports the transformative and transportivefunctions of the spleen and uplifts the yang qi of the spleenand stomach. It treats spleen qi deficiency characterized bypoor digestion and poor assimilation, abdominal pain dueto spleen qi deficiency, general fatigue, poor appetite,anorexia, prolapsed organs, uterine bleeding due to spleenqi deficiency, and chronic diarrhea. Because astragalus isused to tonify the spleen, it is also used to engender blood.It is useful for postpartum fever due to blood and qi defi-ciency and can be used to assist recovery after severe bloodloss (Bensky and others 1993; Li 1590; Pharmacopoeia ofthe People’s Republic of China 1997).

Lung Qi Tonification andSecuring the ExteriorAstragalus tonifies the lungs which govern the protectiveqi, which in turn governs and secures the exterior. It isused to alleviate qi deficiency edema, protect against windcold external patterns, and treat excessive sweating andshortness of breath caused by qi deficiency. It may also beused to promote sweating in instances when diaphoreticsare ineffective (Bensky and others 1993; Li 1590;Pharmacopoeia of the People’s Republic of China 1997).

Promotes Discharge of Pus andGrowth of New TissueAstragalus enhances the eliminative functions of the skin,especially in promoting the healing or elimination of non-healing or nonsuppurative chronic sores or ulcerationscaused by deficiency (Bensky and others 1993;Pharmacopoeia of the People’s Republic of China 1997).

Immune SupportIn China, astragalus is often used to prevent the collapse ofimmune function associated with conventionalchemotherapy and radiation therapy for cancer (Wang1989). These immune-enhancing therapies are known asfu zheng gu ben, which means to “restore the correct andsecure the root”. Such therapies are used to enhance non-specific immunity, protect adrenal cortical function duringradiation and chemotherapy, and ameliorate bone marrowdepression (Lau and others 1989).

ActionsAstragalus tonifies spleen, lung, and vital qi: engendersblood; uplifts yang; secures the exterior and reinforces theprotective qi; promotes growth of new tissue; promotesurination; promotes suppuration; reduces edema. In addi-tion to these classically recognized uses, a review of the tra-ditional literature reveals that it drains yin fire (Ang 1694;Li 1590) and that its effects are numerous depending uponwith which herbs it is combined.

The honey-fried root is used to tonify qi, uplift yang,and invigorate the spleen (Bensky and others 1993; Li1590; Pharmacopoeia of the People’s Republic of China1997).

T r a d i t i o n a l C h i n e s e M e d i c i n e S u p p l e m e n t

Huang Qi

Amer i c an He rba l Pha r mac opo e i a ™ • A s t ra g a l u s Ro o t • TCM Supp l emen t • Augu s t 1999 23

IndicationsQi deficiency; general weakness, lethargy. Lung qi and weiqi deficiency; shortness of breath, recurring colds, exces-sive sweating, and inhibited urination. Spleen qi deficien-cy; anorexia, loose stools, chronic diarrhea, organ prolapse.Astragalus also treats wasting thirst syndromes such as dia-betes (Bensky and others 1993; Li 1590; Pharmacopoeia ofthe People’s Republic of China 1997). Immunologic dis-eases.

Many references state that astragalus is contraindicat-ed for hot pathologies due to its warming and tonifyingnature. However, various classic references specifically citeits use in draining heart and lung fire, draining deficiencyfire, and for treating wind heat toxin (Ang 1694; Li 1590).According to Wang An the actions of astragalus varydepending upon with which herbs it is combined. Hereports, “When used in harmonizing preparations, it toni-fies and supplements; in sweating preparations, it relievesthe surface; in cooling preparations, it drains pathogenicheat; in moistening preparations, it nourishes the yin andblood.” According to the Pharmacopoeia of the People’sRepublic of China (1997), astragalus is additionally usedfor albuminuria in chronic nephritis and diabetes mellitus.

Standard Formulas• Tonify the Middle and Augment the Qi Decoction

[bu zhong yi qi tang]: tonifies middle burner qi,uplifts yang.

• Jade Windscreen Powder [yu ping feng san]:augments qi, secures the exterior, stops sweating.

• Astragalus and Cinnamon Twig Five SubstanceDecoction [huang qi gui zhi wu wu tang]: tonifiesqi, warms and harmonizes the channels, unblockspainful [bi patterns] obstructions.

• Astragalus Decoction to Construct the Middle[huang qi jian zhong tang]: warms and tonifies themiddle burner, moderates spasmodic abdominalpain. Used in severe qi deficiency (Bensky andBarolet 1990).

S A F E T Y P R O F I L E

ContraindicationsAstragalus should be used with care in most excess heatpathologies. It is contraindicated for qi stagnation, dampobstruction, and food stagnation. When the exterior isexcess and the pathogen is flourishing, astragalus is alsocontraindicated for hot toxic skin lesions (Bensky and oth-ers 1993).

Illustration of astragalus [huang ch’i] from theCh’ung-hsiu cheng-ho pen-ts’ao (1249)

24 Amer i c an He rba l Pha r mac opo e i a ™ ~ A s t ra gu lu s Ro o t ~ Augu s t 1999

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American Herbal Pharmacopoeia™PO Box 5159Santa Cruz, CA 95063 USTel: 831-461-6335Fax: 831-475-6219Email: [email protected]: herbal-ahp.org

T A B L E O F C O N T E N T S

Nomenclature 1Botanical NomenclatureBotanical FamilyDefinitionCommon Names

History 1

Identification 2Botanical IdentificationMacroscopic IdentificationMicroscopic Identification

Commercial Sources and Handling 7CollectionQualitative DifferentiationDryingCultivationProcessingAdulterationStoragePreparations

Constituents 9

Analytical 10Thin Layer Chromatography (TLC/HPTLC)High Performance Liquid Chromatography (HPLC)Qualitative Standards

Therapeutics 14PharmacokineticsPharmacodynamics

Immunomodulatory EffectsCardiovascular EffectsHepatoprotective EffectsAntiviral EffectsAntioxidant EffectsOther EffectsConclusion

ActionsIndicationsSubstantiated Structure and Function ClaimDosages

Safety Profile 20Classification of the American Herbal Products AssociationSide EffectsContraindicationsInteractionsPregnancy, Mutagenicity, and Reproductive ToxicityLactationCarcinogenicityInfluence on DrivingPrecautionsOverdoseTreatment of OverdoseToxicology

International Status 21

Traditional Chinese Medicine Supplement 22

References 24

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