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第二章
导学
Chapter 2 Learning Guidance

第一节 药学综合实验简介
1 Brief lntroduction to the Pharmaceutical lntegrated Experiments

传统实验教学大多是单一型实验,是针对某一课程的单一知识点、用单一方法或技能所设置的实验,旨在加强学生对某一知识点采用单一方法进行的验证性的技能训练,即使是课程内的综合型实验,综合的也仅仅是同一课程的不同知识点、不同方法或技能。

现代综合性实验大多是指实验内容涉及一门课程的综合知识或与本课程相关课程知识的实验,其内容应涉及一门课程或者多门课程的多个知识点,是对多项实验内容的综合。本教材设计的药学综合实验是上海中医药大学教学改革的创新实验。本教材以天然药物(或中药)新药研发的基础研究为主线,在整合了生药学、天然药物化学、药剂学、药物分析、药理学的教学资源的基础上开展的集探索性、设计性、TBL和双语实验教学为一体的多样式药学综合实验教学。实验目的是提高药学或中药学专业的教学质量、培养学生实际动手能力、专业知识综合运用能力、自主学习和创新精神,提高学生的专业英语水平,以达到提高学生的综合素质,培养复合型和创新型药学人才的目的。

The conventional experimental teaching is often designed with a single type of experiment,introduces a single method or skill,and focuses on a single knowledge point of a certain course,which aims at deepening students’ understanding on a certain knowledge point through the confirmatory skill training with a single method.Even in the case of an intra-curriculum integrated experiment,it only integrates different knowledge points,methods or skills within the same course.

Modern integrated experiments mostly refer to experiments involving comprehensive knowledge of a course or related knowledge from other courses.The design of pharmaceutical integrated experiment designed in this book is an innovation of the educational reform of Shanghai University of Traditional Chinese Medicine.With the fundamental investigation on the new drug research and development of natural medicines (or Chinese Materia Medica)as the principle line,this book is a diversified pharmaceutical comprehensive experimental teaching material which integrates exploration,designability,TBL,and bilingual experimental teaching by integrating instructional resources of Pharmacognosy,Natural Medicinal Chemistry,Pharmaceutics,Pharmaceutical Analysis,and Pharmacology .The reform purpose of these experiments is to enhance the teaching quality for the major of Pharmacy or Chinese Materia Medica,to train students’ practical operational ability,comprehensive application competence of the professional knowledge,self-learning ability and innovative spirit,to improve their professional English levels,and finally advance their comprehensive quality and cultivate interdisciplinary and innovative pharmaceutical talents.

第二节 药学专业知识在综合实验中的综合应用
2 Comprehensive Application of Pharmaceutical Knowledge in Pharmaceutical lntegrated Experiments

药学综合实验要求学生必须完成生药学(或中药鉴定学)、天然药物化学(或中药化学)、药剂学(或中药药剂学)、药物分析(或中药分析)、药理学(或中药药理学)、药学文献检索(包括中药文献检索)和科研论文写作等课程学习后方可选课。以下是各学科知识的综合运用和主要知识点。

国内常用的生药绝大多数是在历代本草中已有记载的中药。由于历代本草记载、地区用语、地区用药习惯的不同,部分中药外形相似以及人为造假等原因,使中药材品种混乱现象严重,常有同名异物、同物异名现象发生,如中药女贞子,别名冬青子,为木犀科植物女贞 Ligustrum lucidum Ait.的果实,在某些地区同科植物冬青 Ilex chinensis Sims的果实亦作为女贞子药用。该药既存在同名异物现象,又有同物异名问题。另外中药一药多基原情况较为普遍,如大青叶在历史上不同地区用药习惯不同,分别有不同科的植物叶入药,分别为十字花科植物菘蓝 Isatis indigotica Fort.、蓼科植物蓼蓝 Polygonum tinctorium Ait、爵床科植物马蓝 Strobilanthes cusia (Nees) O.Ktze和马鞭草科植物大青 Clerodendrum cyrtophyllum Turcz.。利用生药学或中药鉴定学知识进行真实性鉴定即基原鉴定是保证中药使用的安全、有效及质量可控的基础,是一切中药研究的前期保障,基原一错,满盘皆否。中药的真实性鉴定依据《中华人民共和国药典》及各级药品标准进行,即根据该中药的性状、显微、理化等特征,鉴定其原植(动)物学名。在鉴定生药(或中药)的真伪优劣实验方面,本实验设计提供多基原药材及易出现混乱品种的未知生药,要求学生利用生药学和分析化学知识相结合鉴定原材料的真伪优劣,从中选出优质、正品药材,为后续主要化学成分的提取分离等实验提供保障。

在正确选择了实验用药材的基础上,利用天然药物化学知识设计科学可行的提取分离和纯化工艺,获得期待的提取物,为后续的药理学、中药质量分析的含量测定方法学研究和药剂学方面的研究提供实验样品。

药理学(或中药药理学)实验设计应严密整合“处理因素、实验对象、实验效应”三大要素,严格遵循“随机、对照、重复”三大基本原则,并采用正确的统计学方法处理实验结果,研究工作才能对药物的有效性做出客观准确的评价。中药是天然药物的重要组成部分,但是又有其特殊性。因此在药学综合实验中,中药的药效学研究还需在中医药理论指导下,根据中药的功效主治,选用或建立与中医“证”或“病”相符或相近似的动物模型和实验方法,制定具有中医药特点的实验方案。

利用药物分析和中药质量分析知识对新药有效成分、活性或指标性成分的含量测定方法进行方法学考察研究,包括线性关系、精密度、重现性、稳定性及回收率实验等,上述实验建立的含量测定方法可用于新药或原材料所含化学成分质量控制。

利用药剂学(或中药药剂学)知识研究适合该化学成分或提取物等的适宜剂型及溶出度。

通过上述实验,总结出各学科在天然药物或中药在新药研究中各知识点的应用及相互关系,对实验中出现的问题提出合理解决方法,写出实验论文。实验教学以组为单位,以学生为主体形式汇报成果。各学科带教老师共同点评,对综合实验给出综合成绩。

The course of pharmaceutical integrated experiment could not be selected until the completion of the following courses,which are Pharmacognosy (or Identificology of Chinese Medicinal Substances ), Natural Medicinal Chemistry (or Chinese Medicinal Chemistry ), Pharmaceutics (or Chinese Pharmaceutics ), Pharmaceutical Analysis (or Analysis of Chinese Medicine Preparations ), Pharmacology (or Chinese Pharmacology ), Pharmaceutical Literature Retrieval (including Chinese Pharmaceutical Literature Retrieval ), and Scientific Paper Writing ,etc.The following presents the comprehensive application of the knowledge from each discipline and the major knowledge points.

Most crude drugs commonly used domestically were recorded in monographs of Chinese Materia Medica of past dynasties.Due to different records in different dynasties,different languages and drug preference in different regions,as well as similar-looking of Chinese medicinal substances and counterfeit ones,the market of Chinese crude drugs is in chaos with Chinese herbs in various species being homonymic or synonymic.For instance,Ligustri Lucidi Fructus (Nü Zhen Zi) a.k.a.Dong Qing Zi,is the fruit of Ligustrum lucidum Ait.,a plant belonging to the family of Oleaceae.However,the fruit of Ilex chinensis Sims (Dong Qing)of the same family is also used as Ligustri Lucidi Fructus in some districts.Both homonym and synonym were cited for this herb.In addition,the multiple-origin-for-one-single-herb is also popular for Chinese medicinal substances.In the case of Isatidis Folium,due to the drug preference in different districts recorded in the past,leaves used for the medicinal purpose were from the following families,such as Isatis indigotica Fort.of Cruciferae, Polygonum tinctorium Ait of Polygonaceae, Strobilanthes cusia (Nees) O.Ktze of Acanthaceae,and Clerodendrum cyrtophyllum Turcz.of Verbenaceae.The authenticity identification,a.k.a origin identification on the basis of the knowledge of Pharmacognosy or Identificology of Chinese Medicinal Substances ensures the safety,efficacy,and quality controllability of the Chinese Materia Medica usage,and gurantees Chinese Materia Medica researches in advance.If the origin is incorrect,everything done is in vain.The authenticity identification of Chinese medicinal substances is mainly based on Chinese Pharmacopoeia ,in terms of characters,microscopic and physiochemical properties,identifying the Latin names of the original plant or animal of the drug material.In the aspect of identification of the authenticity,superiority/inferiority of drug material (or Chinese medicinal substances),experiments designed in this book provide students with drug materials of multiorigin and unknown crude drugs of chaotic species,and the students are required to identify the authenticity,superiority/inferiority of the drug materials and to select good-quality drug materials by integrating the knowledge of Pharmacognosy and Analytical Chemistry ,in order to guarantee the proceeding of the extraction and isolation experiments of major chemical components.

Based on the selection of proper drug materials,the scientific and feasible experiment design of extraction,isolation,and purification technologies target extract could be obtained,which provides experimental samples for subsequent pharmacologic research,methodological research of content determination for quality evaluation and pharmaceutical research.

The experimental design of Pharmacology (or Chinese Pharmacology ) should strictly integrate three elements of “studying factor,experimental subject,and experimental effect”and observe three principles of “randomization,control,repetition”; meanwhile,the correct statistical methods should be applied for the processing of experiment data.In this way,drug effectiveness could be evaluated objectively and accurately.As an important part of the natural medicines,Chinese medicinal substances still have uniqueness.Therefore,pharmaceutical integrated experiments,especially experiments related to pharmacodynamic research on Chinese medicinal substances,should be conducted under the guidance of TCM theories,selecting or establishing animal models and experimental methods in accordance with Chinese medicine“patterns” or “diseases” and designing experimental programs with TCM features based on the effects and indications of Chinese medicinal substances.

The methodological studies on the content determination of bioactive or marker components of the Chinese Materia Medica new drugs are performed by taking advantage of the knowledge of Chinese Materia Medica quality analysis,in terms of the linearity,precision,repeatability,stability,and recovery.The obtained assay method is then used as the quality standard for the quality control of new drugs or the chemical components contained in the drug materials.

The knowledge of Pharmaceutics (or Chinese Pharmaceutics) is used to develop a proper dosage form and dissolution rate.

According to the aforementioned experiments,the application and mutual relationship of each knowledge point in the research of natural medicines or new drugs of Chinese Materia Medica are summarized.The reasonable solution should be proposed to target the problems occurring in the course of experiments.The experimental thesis is then written and the results should be reported group by group with the students as the main body.The teachers from each discipline examine together to give a comprehensive score on the integrated expeimental section.

第三节 药学文献查阅及论文撰写
3 Retrieval of Pharmacological Literatures and Paper Writing

文献检索是利用各种检索工具从数量庞大的知识和信息源中查找所需知识和信息的过程。中医药文献检索是中医药专业人员获取中医药信息的基本途径。通过中医药文献的检索获得的信息可以使研究者在前人研究的基础上进行再创造,从而避免重复研究、节省研究人员的大量时间、少走或不走弯路。因此成功的信息检索对中医药科学研究和产品开发及利用具有重要的意义。常用中药学文献检索查询手段、推荐网站及数据库详见下篇知识链接。

药学(或中药学)论文从不同角度看,有多种分类,如文献综述、研究性论文、简讯等。本教材重点介绍与药学综合实验相关的文献综述论文和基础研究论文的写作。主要包括综述论文和科研实验论文。

1.药学(或中药学)综述论文的撰写 药学综述论文属于归纳性综述,归纳性药学综述是作者将搜集到的文献资料进行整理归纳,反映出某一天然药物或某一方法等在一定时期内的研究工作进展情况。可以把该天然药物或该方法各方面研究的最新进展、新水平、新发现、新原理及技术和新趋势比较全面地介绍给读者,为从事该天然药物领域的研究者提供参考。综述论文基本不需要作者自己的见解和观点,但可有适当的总结及展望。

2.药学(或中药学)科研论文的撰写 药学科研论文是科研工作的一部分,是科研成果的一种表现形式。论文写作的目的是交流思想、记录、保存和传播研究成果。本综合实验以学位论文的方式体现,按照温哥华格式撰写,要求是具有科学性、创新性、实用性、规范性。药学(或中药学)论文的具体写作方法和要求见下篇知识链接。

Literature retrieval refers to a process of searching the required knowledge and information from numerous knowledge and informational sources by diverse search tools.The TCM literature retrieval is the basic approach for the acquisition of TCM information for TCM professionals.The researchers can recreate,on the basis of the previous studies due to the availability of information obtained through TCM literature retrieval,avoid the repeated studies,save plenty of time,and avoid detours.Therefore,the successful information retrieval is of vital significance for TCM scientific research and product development and utilization.The common approaches for the Chinese Materia Medica literature retrieval,recommended websites and related databases are available in the knowledge links of part two.

Pharmacological (or Chinese pharmacology) papers can be classified into versatile categories from different points of view,such as review paper,research paper and short communication,etc.This teaching material focuses on the introduction of the scientific writing of review articles and research papers associated with pharmaceutical integrated experiments.It mainly includes the literature review papers and scientific research papers.

3.1 Writing of pharmacological (or Chinese pharmacology) review paper

Pharmaceutical review papers belong to the conclusive reviews.The conclusive pharmaceutical reviews give an index to research progress of a certain natural medicine or a certain method within a certain period,with the retrieved document literature summarized and collated by the authors.The pharmaceutical reviews can comprehensively introduce the latest progress,new levels,new findings,new principles,new technologies and new trends in all fields with respect to the target drug material or method to the readers,providing reference to the researchers having the interest in this drug material.The review papers in general do not require the authors to express their own understandings and viewpoints,but appropriate summary and outlook will be well accepted.

3.2 Writing of pharmacological (or Chinese pharmacology) research paper

Pharmaceutical scientific papers are parts of the scientific research work and a type of manifestation of the scientific achievements.The writing of scientific research papers aims to exchange ideas,record,preserve and transmit scientific outcome.In the form of academic dissertation of Vancouver format,the part of integrated experiment requires scientificity,innovativeness,practicability,and standardisation.Detailed writing methods and requirements for pharmacological (or Chinese pharmacology) papers are available in the knowledge links offered in part two. 7nsQRRH1Yhgq7WyZs5JinTqCrp21hHKCbDvSS44K7wno4YGEG/msPyHJjIiYxnPS

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