This document discusses traditional herbal medicines and phytotherapy. It begins with a brief history of traditional medicines from China, India, the West, and other regions. Herbal medicines and complementary alternative medicines are commonly used, with 25% of prescribed drugs in the US containing plant-derived active substances. The document then defines various types of traditional herbal preparations, including jamu from Indonesia. It describes standardized herbal medicines, phytopharmaca, and potential contaminants in herbal medicines. The document discusses toxicity testing, interactions with conventional drugs, and issues like adulteration. In summary, it provides an overview of traditional herbal medicine practices globally and in Indonesia, defines various preparation types, and discusses quality, safety
This document discusses pharmacovigilance as it relates to herbal medications. It defines pharmacovigilance and outlines its goals of improving patient safety, public health, and risk assessment of medicines. It then discusses specific challenges in monitoring the safety of herbal medicines, including quality control issues due to their complex chemical profiles. Several methods for herbal pharmacovigilance are described, including spontaneous adverse event reporting, prescription event monitoring, and reporting by herbal practitioners. Some herbs with known safety risks are highlighted as examples.
The branch of herbal medicine that describes the potentials and limitations of herbal drugs in the treatment of human diseases and should be practiced by physicians trained in herbalism.
Herbal medicine has a long history dating back to ancient civilizations. It involves the use of whole plants or plant extracts rather than isolated compounds. Herbal medicines are classified as complementary and alternative medicine. Key differences between herbal medicines and conventional drugs include safety, cost, active compounds present at lower concentrations with varying compositions, and actions through synergistic effects of multiple compounds. Herbal medicines are also classified based on potency from highly potent requiring specialist use to gentle and mild forms generally safe for self-treatment.
PHARMACOLOGY NOTES REVISED BY KelvinKean 1.pptkkean6089
This document provides an overview of pharmacology concepts and commonly used drugs. It defines key terms like pharmacology, pharmacodynamics, pharmacokinetics and toxicology. It also discusses drug interactions, dependence, and sources of drugs from plants, animals, inorganic sources and synthetic sources. The document outlines naming conventions for drugs and their uses for curative, symptomatic and preventive purposes. It also lists common drug forms and preparations like tablets, liquids, and capsules.
Phytopharmacueticals.pdf for pharmacy studentsGulyChwas
This document discusses phyto-pharmaceuticals and herbs as raw materials. It defines phyto-pharmaceuticals as herbal remedies prepared from dried plant parts traditionally used to cure illnesses. It emphasizes the importance of standardized herbal extracts for consistent efficacy and safety. It also discusses guidelines for quality of herbal drugs and cosmetics. Regarding herbs as raw materials, it covers the selection, identification and authentication of herbal drugs, as well as their cultivation, collection and processing into final herbal products.
This document provides an introduction to pharmacology for nursing students. It defines key terms like pharmacology, drugs, medicines, dosage, and branches of pharmacology. It discusses the absorption, distribution, metabolism, and excretion of drugs. It also covers classifications of drugs based on their source and sale status. Various concepts in pharmacology are explained like bioavailability, therapeutic index, drug interactions, and factors affecting drug response.
Pharmacology is the study of drug action and pharmacognosy is the study of drugs from natural sources. The major divisions of pharmacology are pharmacodynamics, which studies how drugs affect the body, and pharmacokinetics, which studies how the body affects drugs. Drugs can come from plant, animal, microbial, or synthetic sources. Common routes of drug administration include oral, sublingual, rectal, intravenous, intramuscular, and subcutaneous. The ideal properties of a drug include effectiveness, safety, minimal side effects, and ease of administration.
This document discusses pharmacovigilance as it relates to herbal medications. It defines pharmacovigilance and outlines its goals of improving patient safety, public health, and risk assessment of medicines. It then discusses specific challenges in monitoring the safety of herbal medicines, including quality control issues due to their complex chemical profiles. Several methods for herbal pharmacovigilance are described, including spontaneous adverse event reporting, prescription event monitoring, and reporting by herbal practitioners. Some herbs with known safety risks are highlighted as examples.
The branch of herbal medicine that describes the potentials and limitations of herbal drugs in the treatment of human diseases and should be practiced by physicians trained in herbalism.
Herbal medicine has a long history dating back to ancient civilizations. It involves the use of whole plants or plant extracts rather than isolated compounds. Herbal medicines are classified as complementary and alternative medicine. Key differences between herbal medicines and conventional drugs include safety, cost, active compounds present at lower concentrations with varying compositions, and actions through synergistic effects of multiple compounds. Herbal medicines are also classified based on potency from highly potent requiring specialist use to gentle and mild forms generally safe for self-treatment.
PHARMACOLOGY NOTES REVISED BY KelvinKean 1.pptkkean6089
This document provides an overview of pharmacology concepts and commonly used drugs. It defines key terms like pharmacology, pharmacodynamics, pharmacokinetics and toxicology. It also discusses drug interactions, dependence, and sources of drugs from plants, animals, inorganic sources and synthetic sources. The document outlines naming conventions for drugs and their uses for curative, symptomatic and preventive purposes. It also lists common drug forms and preparations like tablets, liquids, and capsules.
Phytopharmacueticals.pdf for pharmacy studentsGulyChwas
This document discusses phyto-pharmaceuticals and herbs as raw materials. It defines phyto-pharmaceuticals as herbal remedies prepared from dried plant parts traditionally used to cure illnesses. It emphasizes the importance of standardized herbal extracts for consistent efficacy and safety. It also discusses guidelines for quality of herbal drugs and cosmetics. Regarding herbs as raw materials, it covers the selection, identification and authentication of herbal drugs, as well as their cultivation, collection and processing into final herbal products.
This document provides an introduction to pharmacology for nursing students. It defines key terms like pharmacology, drugs, medicines, dosage, and branches of pharmacology. It discusses the absorption, distribution, metabolism, and excretion of drugs. It also covers classifications of drugs based on their source and sale status. Various concepts in pharmacology are explained like bioavailability, therapeutic index, drug interactions, and factors affecting drug response.
Pharmacology is the study of drug action and pharmacognosy is the study of drugs from natural sources. The major divisions of pharmacology are pharmacodynamics, which studies how drugs affect the body, and pharmacokinetics, which studies how the body affects drugs. Drugs can come from plant, animal, microbial, or synthetic sources. Common routes of drug administration include oral, sublingual, rectal, intravenous, intramuscular, and subcutaneous. The ideal properties of a drug include effectiveness, safety, minimal side effects, and ease of administration.
. Introduction to Pharmacology Course Title: Pharmacology I Course No.: PHAR 2113 Prepared by: Biswajit Biswas Reference: Goodman & Gilman’s Manual of Pharmacology and Therapeutics
2. Pharmacology Greek pharmakon : "drug“ ; and logia : "the study of“. Greek: Pharmacon (Drug) Modern Latin: Pharmacologia 18th Century: Pharmacology The branch of medicine concerned with the uses, effects, and modes of action of drugs.
3. Historic development of pharmacology Worlds oldest pharmacology - from India and China Materia medica (2735 B.C.) by Pan Tsao- contained mainly Plant and metal with few animal products Ayurveda - described by Charaka accordig to Rigveda (3000 B.C.) - includes 300 vegetable drugs , classified into 50 groups according to their effects on symptoms. Papyrus (1500 B.C.) discovered by Eber -700 drugs Modern medicine (from 450 B.C.) by Hippocrates- concept of disease as a pathologic process and organize pharmacology on the basis of observation, analysis and deduction.- use simple and efficacious drugs.
4. Allopathay (James gregory, 1753-1821) -treatment without any rational basis- use symptomatic treatment with obnoxious remedis. Homeopathy (Hanneman, 19th century)-
This document provides an overview of herbal medicine (also known as phytotherapy). It discusses the history and use of herbal medicines, characteristics of herbal drugs, herbal approaches to diseases, and commonly used herbal supplements. The document outlines the objectives of learning about herbal medicine and introduces key concepts such as herbalism, botanical medicine, conventional vs. herbal medicine, and alternative/complementary medicine. Examples of alternative therapies like acupuncture, chiropractic, and cupping are also mentioned.
This document discusses herbs and herbal medicines. It defines herbs as leafy or flowering parts of plants used for culinary, medicinal, or spiritual purposes. Herbal medicines can be raw plant materials, processed plant materials, or herbal medicinal products. The document emphasizes the importance of properly identifying, authenticating, and processing herbal raw materials to ensure safety and efficacy of the final herbal product.
This document provides an overview of key concepts in pharmacology for nursing students. It discusses the following main points in 3 sentences or less:
Pharmacology is the study of drugs and their effects on the body. It utilizes concepts from biology, pathology, and chemistry to understand drug therapies. The history of pharmacology dates back to ancient times when various cultures applied natural remedies, and it began to emerge as a modern science in the 19th century with the isolation of active drug components.
The FDA and other regulatory agencies were created to standardize drugs and ensure they are safe and effective through various laws and standards. The FDA specifically regulates drug approval and safety through three centers that oversee prescription drugs, biologics,
Effects of herbal drugs on clinical laboratories testing Swati Wadhawan
This document discusses the regulation of herbal medicines. It states that herbal medicines should be regulated to ensure their quality, safety and efficacy through mechanisms like licensing, good manufacturing practices, and pharmacovigilance. Manufacturers must adhere to standards and provide detailed product information for registration. Countries should establish regulatory systems and procedures appropriate to their situations to manage the use of herbal medicines.
Application of quality control principles to herbal drugsNarongchai Pongpan
This document discusses the importance of quality control for herbal drugs. It outlines World Health Organization guidelines for standardizing herbal formulations, including quality control of crude materials, stability assessment, safety assessment, and efficacy evaluation. The challenges of standardizing herbal products are also addressed, such as identifying plant materials correctly and issues related to the complexity of polyherbal formulations. Standards from countries like Germany are also discussed. In summary, the document emphasizes the need for quality control and standardization of herbal medicines to ensure safety, effectiveness, and consistency.
STANDARDIZATION AND QUALITY CONTROL OF HERBAL DRUGS.pptxSharang Bali
Standardization and quality control of herbal drugs is important to ensure their efficacy and safety. Herbal drugs can be standardized using various methods including botanical, physical, chemical, and biological. Botanical standardization involves morphological and microscopical studies to identify the plant material. Physical standardization includes determining moisture content, ash value, and extractive value. Chemical standardization uses qualitative chemical tests and analytical methods like chromatography. Biological standardization involves animal and microbial studies. Together, these standardization methods help confirm identity, quality, purity and detect adulteration of herbal drugs.
The document discusses medication history interviews, which are used to obtain a complete record of all medications a patient is currently taking or has taken recently. A medication history interview provides valuable insights into a patient's allergies, adherence to treatments, and use of alternative medicines. The goal is to collect information that can be used to prevent prescription errors, detect drug-related issues, and inform an overall care plan for the patient. Common questions asked during an interview include what medications the patient is currently taking, any allergies or side effects, adherence to past treatments, and use of over-the-counter or herbal remedies.
Pharmacology is the study of medications, or chemical compounds, which interact with various living systems, from tiny molecules to cells, to tissues and whole organisms in order to produce a certain effect
It is science of medicine from plants. It is far different from homeopathy and have various advantages over conventional medicine. Various traditional medicine system existed in past.
This document discusses the various branches of pharmacology. It explains that pharmacology is the study of drugs and their interaction with living systems. Some key branches mentioned are pharmacognosy, which deals with natural drug sources; pharmacy, which involves drug preparation and quality control; pharmacokinetics, which examines how the body affects drugs; and pharmacodynamics, which analyzes how drugs affect the body. The document also defines toxicology, pharmacogenetics, and chemotherapy in relation to pharmacology. It provides the WHO definition of a drug and differentiates drugs from medicines. Finally, it outlines common drug sources and naming conventions.
This document provides an overview of herbal medicines. It discusses that herbal medicines are plant-based preparations used in traditional and modern medical practices. The World Health Organization defines herbal medicines and categorizes them. The document then covers the scientific and non-scientific reasons for using herbal medicines to treat diseases. It also discusses herbal medicine safety, efficacy, present market scenario, and potential future developments. In particular, it notes the growing interest in herbal medicines due to concerns about side effects of synthetic drugs, herbal medicines' potential as sources of new pharmaceuticals, and their widespread traditional use.
Pharmacology is the study of drugs and their actions on the body. Drugs are chemicals used to diagnose, treat, and prevent disease. This document outlines general principles of pharmacology, including drug names, classifications, routes of administration, and factors that can influence drug response. It emphasizes the importance of understanding pharmacokinetics and following legal and safety guidelines when providing patient care using medications.
This document provides an introduction to pharmacology. It defines key terms like efficacy, potency, therapeutic index, and adverse drug reactions. It describes pharmacokinetic principles such as absorption, distribution, metabolism and elimination of drugs. It also discusses pharmacodynamics concepts like agonists, antagonists, and drug-receptor interactions. The document outlines various drug classifications and therapeutic categories. It discusses routes of drug administration including enteral and parental routes. It also covers topics like drug interactions, drug labeling, and patient records.
The document discusses the benefits and risks of traditional herbal medicine. It notes that while herbal medicines are more affordable and their natural ingredients may cause fewer side effects than pharmaceutical drugs, their dosages are not standardized and long term use or high dosages could potentially damage organs. It emphasizes that herbal medicines should be used preventatively, not to treat diseases, and that consumption should be stopped if symptoms don't improve after a few days. The document also warns that herbal medicines could interact negatively with other drugs and their safety has not been proven through clinical trials in the same way as pharmaceutical medicines. Overall, it suggests that while herbal medicines have some benefits, they also carry risks and should be consumed carefully and not as a
The document discusses the benefits and risks of traditional herbal medicine. It notes that while herbal medicines are more affordable and their natural ingredients may cause fewer side effects than pharmaceutical drugs, their dosages are not standardized and long term usage could potentially damage organs. It emphasizes that herbal medicines should only be used for prevention or to complement pharmaceutical treatments, not as standalone cures, and cautions around risks like interactions with other drugs, reactions varying between individuals, and potential contamination. It concludes that more scientific evidence is needed to prove the safety and efficacy of herbal medicines.
The document discusses the benefits and risks of traditional herbal medicine. It notes that while herbal medicines have affordable prices and are considered more natural, their effects are often not as fast as modern medicines. It also warns that herbal medicines may have side effects, especially if consumed without proper dosage, for too long, or in combination with other drugs. The document emphasizes that herbal medicines should generally only be used for prevention or minor ailments, and that medical treatment is still needed for serious illnesses. Overall, it argues that while herbal medicines are popular, their safety and efficacy have not been scientifically proven through clinical trials in the same way as conventional drugs. Caution is advised in consuming herbal remedies.
This document provides an introduction to the field of pharmacognosy. It defines pharmacognosy as the study of drugs from natural sources, including their composition, characteristics, and uses. The document outlines the history of pharmacognosy from ancient Greek physicians to modern studies of plant and animal extracts. It also discusses the scope of pharmacognosy, key terms, classification systems for natural drugs, and sources of medicinal compounds.
This document discusses issues with solid phase extraction (SPE) as a sample preconcentration method. SPE provides lower detection limits than large sample volumes but can show artifacts from incomplete recovery. The Regional Monitoring Program uses SPE to process 100L water samples through glass fiber filters and XAD2 resin columns. Comparisons of 100L SPE samples to 4L solvent extraction samples show the SPE method may underestimate for high organic samples due to short contact times, while overestimating for low organic samples where solvent extraction recovers more. Alternatives like switching to solvent extraction are not preferable due to increased sampling and shipping volumes required. The status quo 100L SPE method is preferred if its tendencies toward over or under-estimation are taken into account.
Dokumen tersebut memberikan penjelasan singkat tentang proses fotosintesis pada tumbuhan, meliputi definisi fotosintesis, reaksi kimia yang terjadi, komponen-komponen yang terlibat seperti klorofil, air dan karbondioksida, serta perbedaan mekanisme fotosintesis pada tanaman jenis C3, C4 dan CAM.
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. Introduction to Pharmacology Course Title: Pharmacology I Course No.: PHAR 2113 Prepared by: Biswajit Biswas Reference: Goodman & Gilman’s Manual of Pharmacology and Therapeutics
2. Pharmacology Greek pharmakon : "drug“ ; and logia : "the study of“. Greek: Pharmacon (Drug) Modern Latin: Pharmacologia 18th Century: Pharmacology The branch of medicine concerned with the uses, effects, and modes of action of drugs.
3. Historic development of pharmacology Worlds oldest pharmacology - from India and China Materia medica (2735 B.C.) by Pan Tsao- contained mainly Plant and metal with few animal products Ayurveda - described by Charaka accordig to Rigveda (3000 B.C.) - includes 300 vegetable drugs , classified into 50 groups according to their effects on symptoms. Papyrus (1500 B.C.) discovered by Eber -700 drugs Modern medicine (from 450 B.C.) by Hippocrates- concept of disease as a pathologic process and organize pharmacology on the basis of observation, analysis and deduction.- use simple and efficacious drugs.
4. Allopathay (James gregory, 1753-1821) -treatment without any rational basis- use symptomatic treatment with obnoxious remedis. Homeopathy (Hanneman, 19th century)-
This document provides an overview of herbal medicine (also known as phytotherapy). It discusses the history and use of herbal medicines, characteristics of herbal drugs, herbal approaches to diseases, and commonly used herbal supplements. The document outlines the objectives of learning about herbal medicine and introduces key concepts such as herbalism, botanical medicine, conventional vs. herbal medicine, and alternative/complementary medicine. Examples of alternative therapies like acupuncture, chiropractic, and cupping are also mentioned.
This document discusses herbs and herbal medicines. It defines herbs as leafy or flowering parts of plants used for culinary, medicinal, or spiritual purposes. Herbal medicines can be raw plant materials, processed plant materials, or herbal medicinal products. The document emphasizes the importance of properly identifying, authenticating, and processing herbal raw materials to ensure safety and efficacy of the final herbal product.
This document provides an overview of key concepts in pharmacology for nursing students. It discusses the following main points in 3 sentences or less:
Pharmacology is the study of drugs and their effects on the body. It utilizes concepts from biology, pathology, and chemistry to understand drug therapies. The history of pharmacology dates back to ancient times when various cultures applied natural remedies, and it began to emerge as a modern science in the 19th century with the isolation of active drug components.
The FDA and other regulatory agencies were created to standardize drugs and ensure they are safe and effective through various laws and standards. The FDA specifically regulates drug approval and safety through three centers that oversee prescription drugs, biologics,
Effects of herbal drugs on clinical laboratories testing Swati Wadhawan
This document discusses the regulation of herbal medicines. It states that herbal medicines should be regulated to ensure their quality, safety and efficacy through mechanisms like licensing, good manufacturing practices, and pharmacovigilance. Manufacturers must adhere to standards and provide detailed product information for registration. Countries should establish regulatory systems and procedures appropriate to their situations to manage the use of herbal medicines.
Application of quality control principles to herbal drugsNarongchai Pongpan
This document discusses the importance of quality control for herbal drugs. It outlines World Health Organization guidelines for standardizing herbal formulations, including quality control of crude materials, stability assessment, safety assessment, and efficacy evaluation. The challenges of standardizing herbal products are also addressed, such as identifying plant materials correctly and issues related to the complexity of polyherbal formulations. Standards from countries like Germany are also discussed. In summary, the document emphasizes the need for quality control and standardization of herbal medicines to ensure safety, effectiveness, and consistency.
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Standardization and quality control of herbal drugs is important to ensure their efficacy and safety. Herbal drugs can be standardized using various methods including botanical, physical, chemical, and biological. Botanical standardization involves morphological and microscopical studies to identify the plant material. Physical standardization includes determining moisture content, ash value, and extractive value. Chemical standardization uses qualitative chemical tests and analytical methods like chromatography. Biological standardization involves animal and microbial studies. Together, these standardization methods help confirm identity, quality, purity and detect adulteration of herbal drugs.
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Pharmacology is the study of medications, or chemical compounds, which interact with various living systems, from tiny molecules to cells, to tissues and whole organisms in order to produce a certain effect
It is science of medicine from plants. It is far different from homeopathy and have various advantages over conventional medicine. Various traditional medicine system existed in past.
This document discusses the various branches of pharmacology. It explains that pharmacology is the study of drugs and their interaction with living systems. Some key branches mentioned are pharmacognosy, which deals with natural drug sources; pharmacy, which involves drug preparation and quality control; pharmacokinetics, which examines how the body affects drugs; and pharmacodynamics, which analyzes how drugs affect the body. The document also defines toxicology, pharmacogenetics, and chemotherapy in relation to pharmacology. It provides the WHO definition of a drug and differentiates drugs from medicines. Finally, it outlines common drug sources and naming conventions.
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This document provides an introduction to pharmacology. It defines key terms like efficacy, potency, therapeutic index, and adverse drug reactions. It describes pharmacokinetic principles such as absorption, distribution, metabolism and elimination of drugs. It also discusses pharmacodynamics concepts like agonists, antagonists, and drug-receptor interactions. The document outlines various drug classifications and therapeutic categories. It discusses routes of drug administration including enteral and parental routes. It also covers topics like drug interactions, drug labeling, and patient records.
The document discusses the benefits and risks of traditional herbal medicine. It notes that while herbal medicines are more affordable and their natural ingredients may cause fewer side effects than pharmaceutical drugs, their dosages are not standardized and long term use or high dosages could potentially damage organs. It emphasizes that herbal medicines should be used preventatively, not to treat diseases, and that consumption should be stopped if symptoms don't improve after a few days. The document also warns that herbal medicines could interact negatively with other drugs and their safety has not been proven through clinical trials in the same way as pharmaceutical medicines. Overall, it suggests that while herbal medicines have some benefits, they also carry risks and should be consumed carefully and not as a
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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
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
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