TRADITIONAL DRUGS AND HERBAL MEDICINES (PHYTOTHERAPY)

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TRADITIONAL DRUGS AND HERBAL MEDICINES(PHYTOTHERA
PY)

• Kuswinarti and Muchtan Sujatno
• Department of Pharmacology Therapy
• Medical School , Padjadjaran University

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• History
• Chinese Traditional Medicine ? Oriental
  Traditional
• Medicine
• Ayurvedic Traditional Medicine from Ayurveda
  (India)
• Western Herbal Medicine
• 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

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INTRODUCTION

• DEFINITION
• Traditional Drugs
• Herbal Medicine
• TOGA
• Phytopharmaca
• Herbal preparations
• Simplicia, Infusion, decoct, etc.

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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.
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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 ? non pharmacological
terminology
JAMU Direction to use Traditionally used for
relieving headache Dosage 1 eatspoon in a glass
of boiled water
LOGO
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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
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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
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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
• JAMU / HERBAL MEDICINE
• Used by Empirical
• Simple preparations
• Named by traditional terminology tolak angin,
  pegel linu, galian singset, lancar haid, gempur
  batu etc.

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PHYTOPHARMACAused 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

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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.
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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
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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

• Adverse effects rarely, but be careful
• SEES (Side effects Eliminating
• Substances)
• Secondary Efficacy Enhancing Substances

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PREPARATION OF AN ORAL DOSAGE FORM

• LIQUID
• Medicinal tea
• Infusion
• Decoction
• SOLID
• Tablets
• Pills
• Powder

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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)

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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

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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

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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

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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)

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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 )

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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

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• 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

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• 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

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Local toxicity test special toxicity tests

• Local toxicity tests
• Skin sensitization test
• Special toxicity tests
• Mutagenicity test
• Carcinogenicity test
• Reproductive and development toxicity test

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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

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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
• flu and became moonface
• Contained prednisolone
• paracetamol

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INTERACTIONS BETWEEN HERBAL MEDICINES AND DRUGS
USED IN ORTHODOX MEDICINE

• Herbal preparation Orthodox
  medicine Interaction
• --------------------------------------------------
  --------------------------------------------------
  -------
• Sedatives
• Sedative prep. Alcohol/antihistamines,hypn
  otics Potentiation
• Tropane alkaloids Alcohol/antihistamines,h
  ypnotics 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

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