SYLLABUS FOR THE COURSE FELLOWSHIP IN STANDARDIZATION OF ISM DRUGS SUBJECTS OF STUDY:

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1 SYLLABUS FOR THE COURSE FELLOWSHIP IN STANDARDIZATION OF ISM DRUGS SUBJECTS OF STUDY: Paper Paper -I Paper II Paper -III Paper -IV Paper -V Subjects STANDARDIZATION & QUALITY CONTROL OF ISM DRUGS BOTANICAL & CHEMICAL TESTING OF ISM DRUGS BIOLOGICAL SCREENING OF ISM DRUGS PRACTICAL AND VIVA - VOCE PROJECT AND VIVA-VOCE Paper I - STANDARDIZATION & QUALITY CONTROL OF ISM DRUGS Chapter I Introduction to Drug Standardization Chapter II General Methods of Processing of Herbs Definition, sources, identification and authentication of herbs. Different methods of processing of herbs like collection, harvesting, garbling, packing and storage conditions. Methods of drying Natural and artificial drying methods with their merits and demerits. Chapter - III Methods of Preparation of Extracts Principles of extraction and selection of suitable extraction method. 1

2 Different methods of extraction including maceration, percolation, hot continuous extraction, pilot scale extraction and supercritical fluid extraction with their merits and demerits. Purification and Recovery of Solvents. Chapter -IV Standardization of Herbal Raw materials and Extracts Standardization of herbal raw materials including Pharmacognostical, physical, chemical and biological methods with examples. Standardization of herbal extracts, physical, chemical and spectral analysis. Qualitative and Quantitative estimation of active principles from standardized extracts by HPTLC. Biological standardization -Pharmacological screening of herbal extracts and Microbiological evaluation of herbal extracts. Toxicity studies of herbal extracts Chapter - V GMP for the Production of ISM Drugs Primary processing of herbal products. Documentation required. Other guidelines for Quality Assurance of Herbal drugs. Chapter -VI Isolation and Estimation of Phytoconstituents Different methods (including industrial) for isolation and estimation of phytoconstituents from the following drugs (with special emphasis on HPLC and HPTLC). Chapter-VII Global Regulatory Status on Herbal Medicines. 2

3 Paper II - BOTANICAL & CHEMICAL TESTING OF ISM DRUGS Chapter-I Chapter-II Chapter-III Introduction to Pharmacognosy Role of Pharmacognosy in the herbal industry. General aspects of cultivation,collection and Processing of Herbal durgs. Good Agricultural Practice. Chapter-IV Chapter-V Plant growth regulators. Fermentation technology : Introduction, Production of secondary plant metabolites by fermentation technology including design and operation of industrial fermentors and Detailed study of production of Ergot alkaloids(selected ISM Drugs) Chapter-VI Recent advances in Pharmacognosy. Drug discovery from Medicinal plant sources. High through put screening. Chapter-VII Phytochemical screening 1. Methods of extraction 2. Analysis of secondary Metabolites 3.Role of biomarkers in crude ISM drug analysis. 4. Isolation of Phyto Constitutes by using Chromotography 4. Identification of Phyto Constitutes by Septra studies 3

4 Paper -III - BIOLOGICAL SCREENING OF ISM DRUGS Chapter - I Toxilogical testing of herbal drugs Use of animals for toxicology testing of ISM Drugs acute, subacute and chronic toxicology studies Chapter - II Pharmacological screening and review of literature for the following group of ISM drugs In vivo and In Vitro methods of screening a) Immunomodulatory drugs and its review. b) Anticancer drugs and its review. c) Antidiabetic drugs and its review. d) Anti hepatotoxic drugs and its review e) Hypolipidemic drugs and its review. f) Antiinflammotory Drugs and its review. g)analgesic drugs and its review. h) Anti Rheumatic Drugs and its review. i) Antifertility screening in Female & Male j) Anti Psychotic drugs and its review Chapter -III a) Anti bacterial studies of ISM Drugs b)antifungal studies of ISM Drugs c)antiviral studies studies of ISM Drugs 4

5 Paper-IV- PRACTICAL & VIVA VOCE I.Evaluation of crude drugs 1. Macroscopic and microscopic evaluation. 2. Determination of ash value. 3. Determination of extractive value. 4. Determination of moisture content. 5. Determination of foaming index. 6. Determination of swelling index. 7. Determination of microbial load. II. Preliminary phytochemical screening of certain medicinal plants Application of TLC and paper chromatography in phytochemical evaluation of crude drugs. III. Isolation and estimation of phyto-constituents 1. Isolation of fixed oils from different sources and their physical,physiochemical and chemical evaluation. IV. Isolation of known marker compounds by column chromatography (Demonstrative) V.Systematic analysis of crude drugs from unknown origin. Paper-V- PROJECT & VIVA VOCE Any ISM drugs screened for Pharmacognosy & Phytochemical studies 5

6 Scheme of Examination Paper Subjects Internal Assessment (IA) Paper -I Paper -II Paper-III Standardization & Quality control of ISM Drugs Botanical & Chemical testing of ISM drugs Biological screening of ISM drugs Paper-IV Practical and Viva - Voce Theory/Practical Viva Max 50 min 25 Max100 min50 No Viva Max 50 min 25 Max100 min50 No Viva Max 50 min 25 Max100 min50 No Viva Max 50 min 25 Max100 min50 Max50 min25 Paper-V Project and viva-voce No IA Max100 min50 Max50 min25 Result: Note: A candidate must secure 50% for a pass in each component of the examination. 6

2. Selection criteria for substances of herbal origin relevant for standardization and quality control of herbal medicines 77

2. Selection criteria for substances of herbal origin relevant for standardization and quality control of herbal medicines 77 Annex 1 WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines 1. Introduction 72 1.1 Background 72 1.1.1 Preparation of the document 73 1.2 Objectives