Quality Assurance Unit Course Specification Assiut University Department of Faculty of Pharmacy Quality control of herbal drug Programme(s) on which the course is given: Bachelor of Pharmaceutical sciences (Clinical pharmacy) Major or Minor element of programmes: Major element Department offering the programme: Faculty of Pharmacy Department offering the course: Pharmacognosy Dept. Academic year / Level: Fourth year/ semester 6th Date of specification approval: I-Basic Information: Title: Quality control of herbal drug Code: PG 606 Credit Hours: Lecture: 2 hr /week Tutorial Practical: 1 hr Total: 3 hr/week II-Professional Information: 1- Overall Aims of Course 1- Knowledge about quality control of herbal medicine 2- Why we carry out quality control 3- Factors affecting on production of active constituents - Determination of the best harvesting time 5- Assessment of processing methods 6- Quality evaluation of herbal medicine either pre- and during marketing 7- Identification and quantitative determination of proprietary products 8- Stability tests of proprietary products 9- Diagnosis of herbal intoxication and its risks 10- Lead compounds for new drug discovery 11- Shortage of chemical markers 12- Methods for quality control a) Physical methods b) Chemical methods c) Chromatographic methods d) Microbiological methods e) Biological methods 13- Detection of the adulterants in herbal medicine
2- Intended Learning Outcomes of Course (ILOs) A- Knowledge and Understanding: After successfully completed the course, student should be able to: A3- mention different methods to estimate the active principles of medicinal plants - mention different factors affecting on the production of herbal medicine -describe different methods for identification and quantitative determination of proprietary products A5-describe different macro and micro morphological characters of medicinal plants B- Intellectual Skills: After successfully completed the course, student should be able to: B2- choose the best method of evaluation of natural product formulation and medicinal herbs B5- Differentiation between the uses, toxicity and safety of natural drugs B7- comprehend, analyze and criticize published information on herbal medicine B8- Conclude that the pharmaceutical natural product suitable for use and suggest of solutions if it is not safe for use. B10-Classify the different factors affecting the production of medicinal plants and the main effect of each class C- Professional and practical Skills: C1- Estimate the active principles and detect adulteration in any given samples of medicinal plant or natural product - Uses of the different methods for the collection, drying, storage of the herbal drugs - Deal with the different methods used in quality control D- General and Transferable Skills: Having successfully completed the course, student should be able to. D2- Apply information technology skills, including word processing, database use, information retrieval through online searches, internet communication and using text books in the library for writing a report in the field of natural product D3- Manage time effectively. D7- Participate in research team concerned with medication by natural products. 2
3- Contents Topic Lectures Introduction, history of quality control 2 Factors affecting production of herbal medicine Assessment of processing methods Quality evaluation of herbal medicine Lead compound for new drug discovery 2 Insuring herbal product quality Multi-tiered GMP standards Monographs from FDA and other legal authorities 6 Total 30 Topic Practical/Tutorial Introduction for quality control 1 Pharmacopeial monographs 3 Microscopical examination of herbal tea 1 Microscopical measurements 1 Assessment of processing methods Applications 3 Revision 1 Total 1 - Teaching and Learning Methods.1- Lectures: using blackboard, OHP, markers, computers and data show.2- Practical training: using laboratory chemicals and laboratory glass wears.3- Discussions.- Class activity.5- Case study.6- Research assignments.7- Field visit 5- Student Assessment Methods 5.1- Practical examination to assess his experimental skills in the isolation and identification and estimation of the chemical constituents. 3
5.2 Written practical examination to solve some problems that may occur during practical classes and to assess recognition of the theoretical bases of practical work. 5.3- Oral examination to assess his ability to understand and evaluate his communication skills and to measure his ability to deal with the society after graduation. 5.- Written examination to assess his knowledge, understanding and his ability to express his scientific knowledge. Assessment schedule Assessment Time 1 Periodical written exam Week 8 th 2 Practical student note Evaluated periodically every week 3 Practical exam Week 15 th Final written exam As decided by vice dean of student affairs 5 Oral exam Weighting of Assessments NO. Exam Mark % 1 Written 50 50% 2 Mid-term 10 10% 3 Practical note 5 5% Practical exam 20 20% 5 Oral exam 15 15% 6 Other type of assessment - - Total 100% 6- List of References 6.1- Essential Books (Text Books): 1- Evans, W.C. Trease and Evans Pharmacognosy Saunders Elsevier, Edinburgh, London, New York, Philadelphia, St Louis, Sydney, Toronto, (16 th Ed., 2009). 2- Heinrich, M. and Barners, J. "Fundamental of Pharmacognosy and Phytotherapy" Elsevier (200). 3- Wagner, H., Bladt, S., "Plant Drug Analysis", Springer, Berlin, (2 nd, 1996). 6.2-Recommended Books: 1- Wagner, H., Bladt, S., "Plant Drug Analysis", Springer, Berlin, (2 nd, 1996).
2-Egyptian Pharmacopoeia 3-European Pharmacopoeia -British Pharmacopoeia 6.3- Periodicals, Web Sites,. etc 1- World Health Organization: "Traditional medicine". [http://www.who.int/mediacentre/factsheets/fs13/en/]. 2- The European Medicines Agency: "Reflection Paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products" [http://www.emea. europa. eu/pdfs/human/hmpc/.] 3- Chan SSK, Li SL, Lin G: Pitfalls of the selection of chemical markers for the quality control of medicinal herbs." J Food Drug Anal" 2007, 15:365-71 Course Coordinator: Head of Department: Prof. Dr. Azza A. Khalifa 5
University Assiut Course Title Pharmacognosy 2 Faculty Pharmacy Course Code. Code :PG 303 Department Pharmacognosy Topic Introduction, history of quality control *Introduction for quality control Factors affecting production of herbal medicine *Pharmacopeial monographs Assessment of processing methods *Pharmacopeial monographs *Microscopical examination of herbal tea Quality evaluation of herbal medicine *Microscopical measurements *Assessment of processing methods Lead compound for new drug discovery *Assessment of processing methods Insuring herbal product quality *Assessment of processing methods Multi-tiered GMP standards *Applications Matrix of the Intended Learning Outcomes (ILOs) of the Course Week 1 2-3 -5 6-7 8 9-10 11-12 K. and U. A3 Int. S. Prof./Pract. S. G./Trans.S. Monographs from FDA and other legal authorities 13-15 *Applications *Revision *Practical exam K. and U. : Knowledge and Understanding; Int. S.: Intellectual Skills; Prof./Pract. S.: Professional and Practical Skills; G./Trans. S.: General and Transferable Skills * Practical lessons Course Coordinator: Head of Department: Prof. Dr. Azza A. Khalifa Date : / /2012 6