TRADITIONAL DRUGS AND

HERBAL MEDICINES
(PHYTOTHERAPY)
Department of Pharmacology &
Therapy
Medical Faculty, Lampung University

INTRODUCTION
DEFINITION :
Traditional Drugs :
Material (plants, animals, mineral), empirical

TOGA
Herbal Medicine
Phytopharmaca

Simplicia
Herbal preparations
Infusion, decoct, etc.

 TOGA
Garden plants
Simple preparations

JAMU / HERBAL MEDICINE :

Empirical
Simple preparations
Traditional terminology : tolak angin, pegel linu, galian singset

PHYTOPHARMACA
Efficacy and safety (+)
Pharmacological terminology : analgetic, diuretic,
antipiretic, etc
= modern drugs / orthodox medicine
Preparations : capsule, tablets, etc
Modern packaging

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

Inventarisasiobservasiseleksi

Uji praklinik obat tradisional

Aman +

Aman +

Aman -

Aman-

Khasiat +

khasiat -

khasiat +

khasiat-

Terus beredar

Terus beredar

+ label klaim

tanpa klaim ind.

Standarisasi

Tdk dipakai

dilarang

sp pen. lanjut

edar

Tek. Farmasi

Isolat

Uji klinik OT

Uji klinik OT

Uji klinik OT

Bermanfaat

bermanfaat

Sederhana

Pelayanan kesehatan

bermanfaat
Obat jadi

ADVERSE EFFECTS & EFFICACY

OF T.D
Adverse effects : rarely
SEES (Side effects Eliminating Substances)
Secondary Efficacy Enhancing Substances

PREPARATION OF AN ORAL DOSAGE

FORM
LIQUID
Medicinal tea
Infusion
Decoction

SOLID
Tablets
Pills

HERBAL MEDICINE ORTHODOX

MEDICINE/MODERN DRUG
ALKALOIDS

Rauwolfia serpentina Reserpine

Ephedra sp
Ephedrine
Atropa belladonna Atropine, scopolamine
Pilocarpus jaborandi Pilocarpine
Vinca rosea
Vincristine, vinblastine

ADVERSE EFFECTS OF HERBAL

DRUGS
Report :
Liver cell necrosis : herbal tea from comfrey leaves
(Symphytum officinale)

General rule :
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
A brief description of the distribution and habitat

Quality specifications
Authenticity
Purity
Assay

Packaging, labeling and storage

Information 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

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 adm. : PO (clinic)
Frequency of adm.
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 adm.= PO
Dose levels : rodents LD ; non rodents toxic signs
Frequency of adm : 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 ten/sex
Non rodents : at least three/sex

Route of adm
The expected clinical route of adm

Adm. Period
The expected period of clinical use

Dose levels
At least three different dose levels

Observations and examination

General signs, body weight , food & water intake
Haematological 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 one week to
months
four weeks

2 weeks to 1

4 weeks to 3

Repeated adm, between one to

six months

3 to 6 months

Long-term repeated adm. for more

9 to 12 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
Replaced by an equivalent related species
Careless gathering, storage, or distribution of medical
plant material
To add modern drugs in the herbal medicine

ADULTERATION OF ASIAN HERBAL MEDICINES WITH

SYNTHETIC DRUG SUBSTANCES
Reference

Preparations

Chemical and clinical details

------------------------------------------------------------------Itdehaag et al

-Chuifong Toukuwan

(1979)

(Hongkong)

One patient developed

Cushings syndrome from

12 pills/day

The pills contained dexamethasone, 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 moonfaced
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,
galactorrhoea
Antidepressant :
Ginseng
Phenelzine
Headaches,insomnia,
visual hallucinations