Quality control of herbal drug

Transcription

1 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 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 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

4 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 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).

5 2-Egyptian Pharmacopoeia 3-European Pharmacopoeia -British Pharmacopoeia 6.3- Periodicals, Web Sites,. etc 1- World Health Organization: "Traditional medicine". [ 2- The European Medicines Agency: "Reflection Paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products" [ 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: Course Coordinator: Head of Department: Prof. Dr. Azza A. Khalifa 5

6 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 K. and U. A3 Int. S. Prof./Pract. S. G./Trans.S. Monographs from FDA and other legal authorities *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