Transcript traditional drugs and herbal medicine

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
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DEFINITION :
 Traditional
Drugs
 Herbal Medicine
 TOGA
 Phytopharmaca
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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
Direction for use
JAMU
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
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TOGA  Tanaman Obat KeluarGA
 Garden
plants
 Simple preparations
 Can be found and planted at home
 First aid before going to hospital
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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
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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
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ADVERSE EFFECTS & EFFICACY
OF OTI/TM
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Adverse effects : rarely, but be careful
SEES (Side effects Eliminating
Substances)
Secondary Efficacy Enhancing Substances
PREPARATION OF AN ORAL DOSAGE FORM
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LIQUID
 Medicinal
 Infusion
 Decoction
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SOLID
 Tablets
 Pills
 Powder
tea
HERBAL MEDICINE BE ORTHODOX
MEDICINE/MODERN DRUG
ALKALOIDS of Plants
The name of the plant
Active substance
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Rauwolfia serpentina
Ephedra sp
Atropa belladonna
Pilocarpus jaborandi
Vinca rosea
 Reserpine (HBP)
 Ephedrine (Asthma)
 Atropine, scopolamine
 Pilocarpine
 Vincristine, vinblastine
(antiviral drugs)
ADVERSE EFFECTS OF HERBAL DRUGS
Liver cell necrosis has been reported
caused by herbal tea from comfrey leaves
(Symphytum officinale)
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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
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Information for fresh, dried and processed plant
materials
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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
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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
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Various pharmacological effects
Animals
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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
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Route 0f administration : PO (clinic)
Frequency of administration
Control group :
Negative (vehicle only)
 Positive ( modern drugs )
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Toxicity investigation of herbal medicines
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Acute toxicity test
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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
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Long term toxicity test
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Animal species
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Sex
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At least two species (rodent & non rodent)
The same number of male and female
Number of animals
Rodents : at least 10/sex
 Non rodents : at least 3/sex
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Route of administration
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Adm. Period
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The expected period of clinical use
Dose levels
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The expected clinical route of administration
At least 3 different dose levels
Observations and examination
General signs, body weight , food & water intake
 Hematological examination
 Renal & hepatic function tests
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Recovery from toxicity
Expected period of clinical use
Adm. period for the
toxicity study
-------------------------------------------------------------------------Single adm. or repeated adm. for less
than one week
2 weeks to 1 month
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
than 6 months
9 to 12 months
Local toxicity test & special toxicity tests
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Local toxicity tests
 Skin
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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
(1979)
-Chuifong Toukuwan
(Hongkong)
Tay and Johnston (1989)
Bury et al
-Dr.Tong Shap Yee’s
asthma pills
-Powder : colds and
flu
(1987)
One patient developed
Cushing’s 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