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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



Aman + Aman + Aman - Aman-
Khasiat + khasiat - khasiat + khasiat-

Terus beredar Terus beredar Tdk dipakai dilarang
+ label klaim tanpa klaim ind. sp pen. lanjut edar

Standarisasi Tek. Farmasi Isolat
Sederhana
Uji klinik OT Uji klinik OT Uji klinik OT

Bermanfaat bermanfaat bermanfaat

Pelayanan kesehatan Obat jadi

Inventarisasiobservasiseleksi


Uji praklinik obat tradisional
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 Adm. period for the
toxicity study
--------------------------------------------------------------------------
Single adm. or repeated adm. for less 2 weeks to 1 month
than one week

Repeated adm., between one week to 4 weeks to 3 months
four weeks

Repeated adm, between one to 3 to 6 months
six months

Long-term repeated adm. for more 9 to 12 months
than six 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 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 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