TRADITIONAL DRUGS AND

HERBAL MEDICINES
(PHYTOTHERAPY)

Kuswinarti and Muchtan Sujatno

Department of Pharmacology & Therapy
Medical School , Padjadjaran University
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 peoples
Users in Indonesia increase
------------- Development of Herbal Medicine
 INTRODUCTION
DEFINITION :
Traditional
Drugs
Herbal Medicine
TOGA
Phytopharmaca

Herbal preparations :
Simplicia, Infusion, decoct, etc.
Jamu is a herbal preparation, an Indonesian traditional
medicine (Obat Tradisional Indonesia OTI)
Departemen Kesehatan RI divided jamu into 3
cathegories :

1. Jamu
2. Standardized herbal medicine
3. Phytopharmaca
Someone was ill. He took a natural substances then he
felt better and healed.
That substances 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) or mix of
those all substances that used from the ancient to heal the illness
base on experiences (empiric). These experiences are passed on
from old generation to the next generation (turun temurun)
Jamu 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

JAMU Direction for use

LOGO non pharmacological

terminology
Direction to use : Traditionally used
for relieving headache
Dosage : 1 eatspoon in a glass of
boiled water
STANDARDIZED HERBAL MEDICINE
Herbal medicine can be made from same type of plant, but it
found from different area, so the effect is also different
standard simplicia :
A. From 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, Fitogaster,
Fitolac, Glucogard, Hi-stimuno, Irex-max, Kiranti pegal linu,
kiranti sehat datang bulan etc.

Obat Herbal terstandar

LOGO
Have a special LOGO

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
Named by 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 by 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

LOGO

PHYTOPHARMACA

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 (Allium sativum L for
hypercholesterolemia).
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 Food Supplement
 ADVERSE EFFECTS & EFFICACY
OF OTI/TM

Adverse effects : rarely, but be careful

SEES (Side effects Eliminating
Substances)
Secondary Efficacy Enhancing Substances
PREPARATION OF AN ORAL DOSAGE FORM

LIQUID
Medicinal tea
Infusion
Decoction

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 Ephedrine (Asthma)
Atropa belladonna Atropine, scopolamine
Pilocarpus jaborandi Pilocarpine
Vinca rosea Vincristine, vinblastine
(antiviral drugs)
 ADVERSE EFFECTS OF HERBAL DRUGS

Liver cell necrosis has been reported

caused by herbal tea from comfrey leaves
(Symphytum officinale)

General rule of simplisia

tested for microbiological quality and for
residues of pesticides and fumigation
agents, toxic metals, likely contaminant and
adulterants, etc
 POTENTIAL CONTAMINANTS
Type of contaminants Examples
______________________________________________________
Botanicals Atropa belladonna, digitalis, Rauwolfia
serpentina
Micro-organism Staph. aureus, E. coli, Salmonella, Shigella,
Psudomonas aeroginosa
Microbial toxins Bacterial endotoxins, aflatoxins
Pesticides & fumigants agents
Metals Lead, Cadmium, mercury, arsenic
Synthetic drugs Analgesic and antiinflammatory agents
(aminophenazone, phenylbutazone,
indomethacin ), corticosteroids, HCT, diazepam
Animals drugs Thyroid hormones
 Quality specifications of plant
materials and preparations
Information for fresh, dried and processed plant
materials
Name and characteristics
Latin, native languages, English
Part of the plant used and its condition
(Root, leaf, flower, fruit, tuber, seed etc)
A brief description of the distribution and habitat
Quality specifications
Authenticity
Purity
Assay
Packaging, labeling and storage
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)
 PHARMACODYNAMIC AND GENERAL
PHARMACOLOGICAL STUDIES OF HERBAL
MEDICINES
Various pharmacological effects
Animals
Species : mice, rats, guinea pigs, rabbits, dogs, etc
Characteristics of the animals : strain, sex, age, holding
conditions
Disease models : chemicals & other modalities
Test assays can use : whole animals, isolated organs/tissue, etc
Administration
Route 0f administration : PO (clinic)
Frequency of administration
Control group :
Negative (vehicle only)
Positive ( modern drugs )
Toxicity investigation of herbal medicines
Acute toxicity test
Animals species : at least two species (rodents & non rodents)
Sex : males & females
Number of animals : rodents 5 animals/sex
non rodents 2 animals/sex
Route of administration= PO
Dose levels : rodents LD ; non rodents toxic signs
Frequency of administration : one or more doses /24 hour period
Observation : toxic signs & severity, onset, progression,
reversibility of the signs ; at least 7-14 day
 Long term toxicity test
Animal species
At least two species (rodent & non rodent)
Sex
The same number of male and female
Number of animals
Rodents : at least 10/sex
Non rodents : at least 3/sex
Route of administration
The expected clinical route of administration
Adm. Period
The expected period of clinical use
Dose levels
At least 3 different dose levels
Observations and examination
General signs, body weight , food & water intake
Hematological examination
Renal & hepatic function tests
Recovery from toxicity
Expected period of clinical use Adm. period for the
toxicity study
--------------------------------------------------------------------------
Single adm. or repeated adm. for less 2 weeks to 1 month
than 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 months

than 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) Cushings syndrome from
12 pills/day
The pills contained dexa-
methasone, indomethacin,
HCT, diazepam
Tay and Johns- -Dr.Tong Shap Yees Theophylline 12 mg
ton (1989) asthma pills
Bury et al -Powder : colds and One patient gained weight
(1987) flu and became 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
 TERIMAKASIH
Pandanglah masalah dengan mata
hatimu
Bukan sekedar memandang dengan
mata di kepalamu