TRADITIONAL MEDICINE HERBAL MEDICINES(PHYTOTHERAPY)

Department of Pharmacology & Therapy

SW

HISTORY :1. Chinese Traditional Medicine Oriental

Traditional

Medicine

2. Ayurvedic Traditional Medicine from Ayurveda (India)

3. Western Herbal Medicine

4. Others : Egypt, Indonesia

25% of prescribed drugs in America at least one active substance is plant origin

Herbal medicine and CAM (Complementary and Alternative Medicine) used by 42% of American

Users in Indonesia increase and all over the world

Development of Herbal Medicine

INTRODUCTION

DEFINITION : Traditional Drugs Herbal Medicine TOGA/Tanaman Obat Keluarga Phytopharmaca

Herbal preparations : Simplicia, Infusion, decoct, etc.

Jamu is a herbal preparation, an Indonesian traditional medicine (Obat Tradisional Indonesia – OTI)

Departemen Kesehatan RI divided herbal medicine into 3 cathegories :

1. Jamu

2. Standardized herbal medicine

3. PhytopharmacaSomeone was ill. He took a natural substances then he felt better and healed.

Substances of jamu could be taken from plants, animal, minerals. This herbal medicine is made by dukun, someone or by a special team in a kingdom.

Traditional Medicine are substances or preparation

consist of plants, minerals, animal, galenic

(sari tumbuhan/plant extract) or mix of those

all substances that used by the ancestor to

heal the illness base on experiences (EMPIRIC).

These experiences are passed on from old generation to

the next generation (turun temurun). This herbal

preparation is called JAMU

JAMU

LOGO

JAMU

Is a pride of IndonesiaJamu Home made and industrial product

Jamu that produced by manufacture has to give label JAMU in every jamu package and give a special logo of jamu

Direction for use : not in pharmacological terminology

Example :

This herbal traditionally used for relief headache.

One eat spoon in 1 glass boiled water no accurate dose

STANDARDIZED HERBAL MEDICINE Herbal medicine can be made from same type

(genus or species) of plant, but it is found from different area, the effect is different

Standard simplicia :A. From a plant that grow in same area with

same

treatment and same drying procedure

B. PLUS preclinical trial to find the special effect and the

safety

C. PRODUCED by fulfill the criteria of CARA PEMBUATAN OBAT TRADITIONAL YANG BAIK (CPOTB)

A & B & C STANDARDIZED HERBAL MEDICINE

Standardized Herbal Medicine has a special LOGO

In BPOM (Badan Pengawasan Obat dan Makanan)-

FDA of Indonesia there are 17 SHB : Diabmeneer,

Diapet, Diapet,Fitogaster, Fitolac, Glucogard, Hi-stimuno, Irex-max, Kiranti pegal linu, kiranti sehat datang bulan, Kuat segar, Lelap, Rheumakur, Virugon, Sehat tubuh, Songgolangit, Stop Diar Plus.

Have a special LOGO

SHM :

Used for increase, decrease, speed up, subside…………

The user compliance is better caused by certainty of effect and safety of the medicine

TOGA Tanaman Obat KeluarGA # Garden plants

#Simple preparations #Can be found and planted at

home #First aid before going to hospital

JAMU / HERBAL MEDICINE : Used by Empirical Simple preparations Name or indication of traditional

terminology : tolak angin, pegel linu, galian singset, lancar haid, gempur batu etc.

PHYTOPHARMACA used in formal health facilities

Standardized Clinical trial Efficacy and safety (+) Ruled by Health Ministry : 1995 SP3T Direction for use in pharmacological

terminology : analgesic, diuretic, antipyretic, etc

= modern drugs / orthodox medicine Preparations : capsule, tablets, ointment, etc Modern packaging 5 phytopharmaca have to be confessed by

BPOM : Nodia, Rheumaneer, Stimuno, Tensigard Agromed and X-gra

PACKAGE of PHYTOPHARMACA

PHYTOPHARMACA

Example of labeling :

Indication : Hypertension

Dysfunction of erection

Immunomodulator, etc.

Dosage : 1 tablet in the morning

1 capsule 3 times a day

etc.

Phytopharmaca are available in formal health care

system : hospital or public heath

service.

It can be prescribed by doctors

It has precaution for person who can directly consumed this drug such as :

Only for patient with hypertension that established by doctor

If side effect occurred, stop medication and contact the doctor

HERBAL MEDICINES (PHYTOTHERAPY)

May have pharmacological actions which affect the patient

Not all herbal medicines are free from adverse effects

May interact with orthodox medicines if they are taken concurrently

In the West is called Food Supplement

ADVERSE EFFECTS & EFFICACY OF OTI/TM

Adverse effects : rarely, but be careful

SEES (Side effects Eliminating Substances) or Secondary Efficacy Enhancing Substances One and another contents of herbal

make together a safety and efficacy of drug

PREPARATION OF AN ORAL DOSAGE FORM

LIQUID Medicinal tea Infusion; it is not solution for infused

SOLID Tablets Pills Powder

HERBAL MEDICINE BE ORTHODOX MEDICINE/MODERN DRUG

ALKALOIDS of Plants

The name of the plant Active substance---------------------------------------------------- Rauwolfia serpentina Reserpine (HBP) Ephedra sp /Ma huang Ephedrine (Asthma) Atropa belladonna Atropine, scopolamine Pilocarpus jaborandi Pilocarpine Vinca rosea Vincristine, vinblastine (anticancer drugs)

Katzung chapter 65

Allium sativum - bawang putih kolesterol

Centella asiatica – pegagan revitalisasi

tubuh dsb

Orthosiphon arsitatus -kumis kucingdiuretik

Typhoniumflagelliforme – keladi tikus anti

cancer

Morinda citrifolia – mengkudu

Piper betle – sirih

Phyllanthus urinaria - meniran

ADVERSE EFFECTS OF HERBAL DRUGS

Liver cell necrosis has been reported caused by herbal tea from comfrey leaves (Symphytum officinale); this plant was not used anymore

General rule of simplisia tested for microbiological quality and

for residues of pesticides and fumigation agents, toxic metals, likely contaminant

and adulterants, etc

POTENTIAL CONTAMINANTSType of contaminants Examples______________________________________________________Botanicals Atropa belladonna, digitalis,

Rauwolfia serpentinaMicro-organism Staph. aureus, E. coli, Salmonella, Shigella, Psudomonas aeroginosaMicrobial toxins Bacterial endotoxins, aflatoxinsPesticides & fumigants agentsMetals Lead, Cadmium, mercury, arsenicSynthetic drugs Analgesic and antiinflammatory

agents (aminophenazone, phenylbutazone,

indomethacin ), corticosteroids, HCT,

diazepamAnimals drugs Thyroid hormones

Drug dosage form for medicinal preparations of plant materials

Powdered plants materials traditional powders and pills

Extracts tablets, granules, ointments and newer types of pills

Purified extracts/pure active constituents isolated from the plants material injections

(phytopharmaca)

Expected period of Adm. period for the

Clinical use toxicity study--------------------------------------------------------------------------Single adm. or repeated adm. for less 2 weeks to 1 monththan one week

Repeated adm., between 1 to 4 weeks 4 weeks to 3 months

Repeated adm, between 1 to 6 months 3 to 6 months

Long-term repeated adm. for more 9 to 12 monthsthan 6 months

Local toxicity test & special toxicity tests

Local toxicity tests Skin sensitization test

Special toxicity tests Mutagenicity test Carcinogenicity test Reproductive and development

toxicity test

ADULTERATION OF COMMERCIAL PRODUCTS

= Mix certain substance into jamu decrease quality and may be harmful Replaced by an equivalent related species To add modern drugs in the herbal medicine Careless gathering, storage, or distribution of medical plant material

ADULTERATION OF ASIAN HERBAL MEDICINES WITH SYNTHETIC DRUG SUBSTANCES

Reference Preparations Chemical and clinical details-------------------------------------------------------------------Itdehaag et al -Chuifong Toukuwan One patient developed(1979) (Hongkong) Cushing’s syndrome from 12 pills/day

The pills contained dexa- methasone, indomethacin, HCT, diazepam

Tay and Johns- -Dr.Tong Shap Yee’s Theophylline 12 mgton (1989) asthma pillsBury et al -Powder for colds One patient gained (1997) and flu weight and moonface

Contained prednisolone +paracetamol

INTERACTIONS BETWEEN HERBAL MEDICINES AND DRUGS USED IN ORTHODOX MEDICINE

Herbal preparation Orthodox medicine Interaction

--------------------------------------------------------------------------------------------------------- Sedatives :

Sedative prep. Alcohol/antihistamines,hypnotics Potentiation Tropane alkaloids Alcohol/antihistamines,hypnotics Potentiation

Endocrine : Antidiabetic prep. Antidiabetic agents, insulin Loss of diabetic

contr. Guar gum Penicillin Reduced bioav.of

ab Rauwolfia, ginseng Drugs causing gynaecomastia, Potentiation of

gynae. phenothiazine comastia, galactorrhea

Antidepressant :

Ginseng Phenelzine Headaches, insomnia,

visual hallucinations

SAINTIFIKASI JAMU DAN PELAYANAN

KESEHATAN : IMPLEMENTASI KONKRIT

JAMU SBG BRAND INDONESIA 2008

Konsepsi Filosofis Saintifikasi Jamu

Pintu penghubung upaya mengangkat harkat jamu di semua level pelayanan, gunakan Dr/Drg sbg duet lit-yan menuju sistem penyelenggaraan jamu sendiri (sbg ICON) berdampingan secara TERHORMAT dgn yansediaan farmasikonvensional sehingga melestarikan BUDAYA BANGSA INDONESIA

PARADIGMA SAAT INI

VALUE:BAGAIMANA JAMU JADI TUAN RUMAH DI REPUBLIK INDONESIA

PERMENKES 3/2010&1109/2007

Pemerolehanbuktiilmiah,thdjamusbgobattradisionalIndonesia,olehdokter(&doktergigi)sbgprofesibersumpah,darisuatuklaimpenggunaanturuntemurunyangbertahapdiarahkanmenopangparadigmasehat:promotif,preventif,rehabilitatifdanpaliatifsebelummenujuindikasikuratifmelaluifasyankes

Jejaring“duet”lit-yandipelbagaiklinikjamusbginfrastrukturpenelitianberbasispelayanan

Tujuan pengaturan saintifikasi jamu (Ps 3 Permenkes 3/2010)

Mendorong terbentuknya jejaring dokter atau dokter gigi dan tenaga kesehatan lainnya sebagai peneliti dalam rangka upaya preventif, promotif, rehabilitatif dan paliatif melalui penggunaan jamu.

Meningkatkan kegiatan penelitian kualitatif terhadap pasien yang tidak sakit dengan penggunaan jamu.

Meningkatkan penggunaan jamu di kalangan profesi kesehatan. Menjamin jamu yang aman, bermutu dan bermanfaat serta

melindungi masyarakat dari penggunaan jamu yang tidak tepat. Meningkatkan penyediaan jamu yang memiliki khasiat nyata

yang teruji secara ilmiah, dan dimanfaatkan secara luas baik untuk pengobatan sendiri maupun dalam fasilitas pelayanan kesehatan.

TERIMAKASIHPandanglah masalah dengan

mata hatimu

Bukan sekedar memandang dengan mata di kepalamu