SUKRASNO SITI KUSMARDIYANI

COURSE AGENDA # TOPIC SCOPE 1 Introduction Scope, objective, plants and medicine, quality, safety and efficacy 2 Concept of crude drug analysis and its product 3 in relation to standardization Factors affecting quality, Concept of standardization(standard and quality) Scope to be measured (biological, physical, chemical and physicochemical parameters) 4 Legal aspect Definition, similarity and differences related to crude drug and their product. Regulation of herbal medicine. 5 Botanic identity test. Morphological, microscopical, micro chemical and genetic methods 6 Macroscopic, microscopic and organoleptical analysis of crude drugs and their products Foreign material, macroscopic and microscopic of crude drugs

- COURSE AGENDA # TOPIC SCOPE 7 Physical and chemical parameters of crude drugs and their products Sample collection, size of powder. Ash content, water content, volatile oil content, foaming index, hemolytic index, fish index 8 Swelling index, pungency index, bitterness index, sweet index 9 Mid Semester 10 Pesticide residues in the crude drug and their analysis 11 Microbe in the crude drug and its analysis Source of contamination, maximal residue level and the determination of the residue Microbial number, molds, specific microbe and micotoxin 12 Quantitative and qualitative analysis of powder Marker in crude drug and their mixture, determination of composition in mixture of crude drug

# TOPIC SCOPE 13 Chemical group testing and quantification - COURSE AGENDA Alcohol, phenol, aldehyde, ketone, acid, ester and lactone, carbohydrate group 14 The glycoside of saponin, steroidtriterpenoid and flavonoid 15 The alkaloid, tannin, quinone and cyanogenic compound 16 Final Examination

Course Objectives After completing the course, students will be able to understand the method for analysis and to apply the method in evaluating crude drugs and their products as well as take part in the standardization of herbal medicine.

REFERENCES Quality Control Methods for Medicinal Plant Material, WHO, Geneva, 2005. Trease and Evans Pharmacognosy, W. C. Evans (Ed.), 16 th ed., WB Saunders, Edinburgh, 2009. WHO Monograph on Selected Medicinal Plants, Vol. I, WHO, Geneva, 1998 Farmakope Herbal Indonesia & Supplements, 2008, 2010, 2011 Current Review of Chinese Medicine,

2005

MONOGRAPHS: CRUDE DRUGS & EXTRACTS

Read and discuss.

INTRODUCTION Scope, objective, plants and medicine, quality, safety and efficacy

-- explain -- Wild Standardized Extract Jamu / TM Standardized Herbal Medicine Phytopharmaca Cultivated Natural Product Standardized Crude Drug Herbal Pharm l Product Cosmetic, Food, Pesticide, etc. Genetically eng. Extract Active (Pure) Compound Inert (Pure) Compound Pharm l Product / Novel Compound -Excipients-

Mesopotamia and Egypt Ebers Papyrus 1600 BC Pedanus Dioscorides (1 BC) more than 600 medicinal plants Hippocrates (Corpus Hippocraticum, 460-375 BC) Claudius Gallen (130-201 AD)

THE USE OF MEDICINAL PLANTS -- explain -- Hippocrates (459-370 SM) Dioscorides (40-80 M) Galen ( 129-200 M) Ibnu Sina, Avicenna ( 980-1037 M)

Bas-relief depicting servants gathering lilies and preparing perfumes and ointments. Egyptian, 650-550 BC or 450-350 BC. The Louvre., Paris.

Taoist: meditation, specific diet, herbal medicine, physical exercise. Shen nong ben cao jing : 365 drugs mostly natural Ben cao Gang Mu (Li Shinzhen: 1518-1593, 1892 drugs and 11000 prescriptions) Shennong tasting herbs to discover their qualities. The Compendium of Materia Medica is a pharmaceutical text written by Li Shizhen (1518-1593 AD) during the Ming Dynasty of China. This edition was published in 1593. Ayurveda (life-knowledge) 1200 BC

Kampo Small dose of TCM Daidoruijoho by 808 984 Ishinho (Yasuyori Tamba) 1574, Edo period, Kampo by Yorimoto Minamoto Jamu Bali, the conserved Majapahit culture Serat kawruh bab jampi-jampi, 1734 prescription Serat Centhini in Surakarta library, 12 volumes, written in 18 century. Sukarno: Berdikari (Self reliance), oriented at Jamu -- get more information --

Emperor Shen Nung +2000 SM, Write the common and scientific names for medicinal herbs in this picture.

DOCTRINE OF SIGNATURE -- explain --

shape, color or general appearance of plants resemble organs of human body -- explain & criticize --

-- explain & criticize -- Shape of plants resemble organs of human body??

Shape of plants resemble organs of human body?? Anisa Nurfitri -- explain & criticize -- cordatus (Latin), cord binahong Anredera cordifolia (Ten.) Steenis.

(NATURAL) MEDICINE Explain how these three factors related to the issues in previous slides. SAFETY QUALITY EFFICACY

Purity Non-toxic High LD-50 No mutagenic activity No teratogenic activity Customer satisfaction Fulfill the minimal requirement Assure consistent performance Evidence base Scientific evidence Clinical evidence Clinical response as indicated Give examples of cases and state your reasons.

Basic principle of quality in herbal medicine Authenticity General quality and purity Assay of the active constituents

-- explain --

Authentication Illustrated by the case of Orthosiphon stamineus and Epatorium reptans as an example -- discuss and give other examples --

Authentication Ginseng (Panax ginseng) - explain & criticize - American ginseng (Panax quinqueefolium) Curent Rev. Chinese Med., Vol. 2, 2006, p3.

Adulteration STANDARDISED Quality assessment of extracts of Ginkgo biloba leaves : total flavonoides 24% total terpene lactones 6% -- criticize -- PRODUCT Curent Rev. Chinese Med., Vol. 2, 2006, p3.

Problems with Herbal Medicine Maximum activity is not always derived from isolated compound. It may be due to the whole crude drug or crude extract. Important: Authenticity and general quality Shelf life of crude drug and preparation

Quality varies Standard must be set Standard relatively low to accommodate the interest producer and assure the availability at any season Producers/manufacturers reduce the quality to minimum standard

Example Producers/manufacturers reduce the quality to minimum standard Belladona herbs contain more stem than alkaloid rich leaves. Atropa belladonna L. SOLANACEAE High quality of volatile oil is mixed with lower grade but still within the limit of the requirement.

Plants in Modern Medicine Drug Raw Material Herbal Medicine Modern Medicine Precursor for semi synthetic Lead Compound

Sampling Preliminary examination General quality evaluation (purity to assure safety) Specific quality evaluation ========================= FA3203 =========================

BP USP BHP 1996 (British Herbal Pharmacopoeia) British Herbal Compendium (1993) USHP ESCOP (European Scientific Commission on Phytotherapy) German Commission E Chinese Pharmacopoeia (1990, 1995) ============================================================SK2013