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药学综合实验以新药研发为主线，依据现行版《药品注册管理办法》，结合实例，根据中药新药研制的相关研究方法和实验手段，综合运用生药学、天然药物化学、分析化学、药剂学、药理学等学科的相关知识、实验技能和方法，学习研发新药的关键技术问题。课程主要涉及中药新药的药学和部分药理学研究，包括药材的真实性研究、有效成分提取分离和纯化工艺研究、药物剂型选择、质量标准制定和药理学研究等内容。
本课程教学采用中—英文双语和Team-Based Learning（TBL）相结合的教学方法，以组为单位进行。教学内容分为上下两篇，上篇包括导学（文献查阅与综述）、综合实验、论文写作、实验拓展和课程总结汇报五部分，下篇为药学综合实验涉及的相关知识。导学部分要求学生在教师指导下、根据综合实验所选药材查阅国内外近10年相关文献，了解该药材的本草考证、市场问题、药材鉴定方法、含有的化学成分及提取分离方法、有效成分或指标性成分的含量测定方法、主要的药理作用和研究方法、药剂研究现状等，并写成综述，为后续综合实验和拓展试验奠定基础。综合性实验部分，围绕中药或天然药物，以新药研究为背景，介绍相关中药及天然药物新药研究方法和实验技能，使学生将所学相关学科知识融会贯通。实验论文写作部分按科研实验论文要求撰写，对实验出现的问题进行充分讨论，寻求解决办法。拓展实验部分是要求学生在综合实验的基础上、结合查阅文献获得的资料，对感兴趣的待开发部分自行选题、自行设计实验方案；或选择其他天然药物集中命题、学生自主设计完整的实验。课程总结汇报以组为单位，采取中英文双语、PPT形式汇报和答辩。课程汇报答辩包括综合实验和拓展实验两部分。下篇为新药研发知识链接部分，主要介绍中药及天然药物新药研究主要内容、相关法规、新药申报与审批程序、中药及天然药物新药申报资料、中药及天然药物新药研究关键技术和方法，以及药学文献的查阅和论文的撰写。
本课程综合实验和拓展试验旨在增强学生的实验操作技能、独立工作能力、分析问题和解决问题的能力；双语教学旨在提高学生的专业英语水平；TBL教学方法旨在提高学生协调性和团队合作的精神，为药学专业学生今后运用现代实验手段从事天然药物的新药研究开发工作奠定基础。
Pharmaceutical Integrated Experiments is designed to focus on the new drug research and development and based mainly on the latest version of “ Drug Registration Regulation ”(implemented in October of 2007 in China),which aimed at teaching students the key techniques in the new drug research and development process by integrating the knowledge,experimental skills and methods in such disciplines as Pharmacognosy,Natural Medicinal Chemistry,Analytical Chemistry,Pharmaceutics,and Pharmacology,etc .The related research approaches and experimental methods in new drug development of Chinese Materia Medica were exemplified with certain showcases.This course is mainly involved in the pharmaceutical section of new drug development chain,including authentication of crude drugs,extraction and purification procedures of effective components,methodological and pharmacological research on setting quality standards,selection of pharmaceutical dosage forms and dissolution, etc .
This course will adopt the methods of bilingual teaching (Chinese-English) and Team-Based Learning (TBL).Students will be divided into teams.The teaching content is classified into two parts,in which part One includes learning guidance (literature searching and review writing),integrated experiments,scientific paper writing,expanding experiments,and course summary and report,while part Two is the related knowledge of pharmaceutical integrated experiments.The guidance learning part requires students,under the instruction of teachers,to retrieve literatures related to the selected experimental natural medicine of the last ten years,to learn its textual research,marketing status,natural medicine identification methods,chemical constituents contained and their extraction and purification methods,assay of effective or marker compounds,major pharmacological actions and research method,current situation of pharmaceutical research,and so on,and to write a literature review for the later integrated experiment and expanding experiments.The part of integrated experiments,focusing on new drug research and development of Chinese Materia Medica compound formulas,introduces related new drug research methods and experimental skills of Chinese Materia Medica and natural medicines,and tends to acquaint students with multi-disciplinary knowledge they have learnt.The experimental thesis should be written in accordance with the requirements for writing lab-based research papers and also the existing problems in the experiment should be thoroughly discussed in order to seek a solution.The expanding experiment part requires students to select their interested drug research project and design their own experimental program,based on the integrated experiment and the acquired literature data; or select other assigned natural medicine project to design a complete experiment.The course summary report will be in groups to report and defend in both Chinese and English with the aid of PPT.The course report and defense should include both parts of integrated experiments and expanding experiments.Part Two is about knowledge of new drug development,including new drug development of Chinese Materia Medica and natural medicines,related policies and regulations,new drug application and review procedures await approval,new drug application dossiers of Chinese Materia Medica and natural medicines,key technologies in new drug research of Chinese Materia Medica and natural medicines,retrival of pharmaceutical literatures and scientific paper writing.
The design of integrated experiment and expanding experiment in this course aims at improving students’ experiment operation skill,independent working ability,problem-analyzing and solving ability.Bilingual teaching may improve the professional English level of students.The TBL teaching method could enhance the coordination ability and spirit of teamwork and lay a solid foundation for pharmaceutical students to engage in the new drug research and development of natural medicines with the application of modern experimental means.