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

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

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
Direction to use : Traditionally
used for relieving headache
Dosage : 1 eatspoon in a glass of
boiled water

non pharmacological
terminology

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
Have a special LOGO

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,

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
Infusion
Decoction

SOLID
Tablets
Pills
Powder

tea

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

Adm. Period
The

expected period of clinical use

Dose levels
At

expected clinical route of administration

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

for the

Adm. period

toxicity study
-------------------------------------------------------------------------Single adm. or repeated adm. for less
month
than one week
Repeated adm., between 1 to 4 weeks
months

Repeated adm, between 1 to 6 months

Long-term repeated adm. for more

than 6 months

2 weeks to 1

4 weeks to 3

3 to 6 months

9 to 12 months

Local toxicity test & special toxicity

tests
Local
Skin

toxicity tests
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

(1979)
(Hongkong)

Tay and Johns- -Dr.Tong Shap Yees

ton (1989)
asthma pills
Bury et al
-Powder : colds and
(1987)
flu

One patient developed

Cushings syndrome from
12 pills/day
The pills contained dexamethasone, indomethacin,
HCT, diazepam
Theophylline
12 mg
One patient gained weight
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