TRADITIONAL DRUGS AND

HERBAL MEDICINES
(PHYTOTHERAPY)
 INTRODUCTION
 DEFINITION :
 Traditional Drugs :
 Material (plants, animals, mineral), empirical
 TOGA
 HerbalMedicine
 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
 Inventarisasiobservasiseleksi

Uji praklinik obat tradisional

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

 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 :
 Livercell 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 to3 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
 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 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