UHDDJKD

1. TRADITIONAL DRUGS AND
HERBAL MEDICINES
(PHYTOTHERAPY)
Kuswinarti and Muchtan Sujatno
Department of Pharmacology & Therapy
Medical School , Padjadjaran University

2. 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

3. INTRODUCTION
 DEFINITION :
 Traditional Drugs
 Herbal Medicine
 TOGA
 Phytopharmaca
 Herbal preparations :
Simplicia, Infusion, decoct, etc.

4. 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.

5. 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 to use : Traditionally used
for relieving headache
Dosage : 1 eatspoon in a glass of
boiled water
LOGO
Direction for use
 non pharmacological
terminology

6. 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

7. 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
Used for increase, decrease, speed up,
subside…………
The user compliance is better caused by
certainty of effect and safety of the
medicine
LOGO

8.  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.

9. 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,
Tensigard Agromed and X-gra

10. 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.

11. 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

12. 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

13. ADVERSE EFFECTS & EFFICACY
OF OTI/TM
 Adverse effects : rarely, but be careful
 SEES (Side effects Eliminating
Substances)
 Secondary Efficacy Enhancing Substances

14. PREPARATION OF AN ORAL DOSAGE FORM
 LIQUID
 Medicinal tea
 Infusion
 Decoction
 SOLID
 Tablets
 Pills
 Powder

15. 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)

16. 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

17. 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

18. 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

19. 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)

20. 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 )

21. 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

22.  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 expected clinical route of administration
 Adm. Period
 The expected period of clinical use
 Dose levels
 At least 3 different dose levels
 Observations and examination
 General signs, body weight , food & water intake
 Hematological examination
 Renal & hepatic function tests
 Recovery from toxicity

23. 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 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 9 to 12 months
than 6 months

24. Local toxicity test & special toxicity tests
 Local toxicity tests
 Skin sensitization test
 Special toxicity tests
 Mutagenicity test
 Carcinogenicity test
 Reproductive and development toxicity test

25. 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

26. 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 moonface
Contained prednisolone +
paracetamol

27. 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

28. TERIMAKASIH
Pandanglah masalah dengan mata
hatimu
Bukan sekedar memandang dengan
mata di kepalamu