【作者】 董国锋；

【导师】 图娅； 孙东东；

【作者基本信息】 北京中医药大学 ， 针灸推拿学， 2009， 博士

【摘要】 [研究背景]标准是为在一定的范围内获得最佳秩序,经协商一致制定并由公认机构批准,共同使用的和重复使用的—种规范性文件。标准化是为在一定范围内获得最佳秩序,对现实问题或潜在问题制定共同使用和重复使用的条款的活动。中医药标准化在促进中医药学术发展,提高中医药临床疗效,加强中医药依法行政,加快中医药走向世界,实现中医药现代化方面发挥着重要作用。然而,由于中医药的特殊性和复杂性,中医药标准化工作在探索发展中存在一些突出问题,其中,中医药标准化工作本身就存在亟需标准和规范的问题。现行中医药标准化法律法规体系很不完善,目前中医药标准化法治建设还很薄弱。因此,中医药标准化要真正切实、很好地发挥作用,其在理论和现实上都需要解决上述亟待解决的突出问题。中医药标准化问题的法学研究能为解决这些突出问题,提供重要的思路、方法、途径和对策。[研究目的]本课题的研究目的是为保证中医药标准化工作各个方面和环节的健康发展和运行提供法学支撑,以保证中医药标准化工作在中医药事业的全面振兴和可持续发展过程中应发挥的基础性技术支撑作用得以顺利有效实现。[研究方法]本课题的研究方法主要采用的是法学研究方法。法学研究方法有三个层次,即:(1)具有普遍指导意义的唯物辩证法。(2)一般科学研究方法:①社会调查方法;②历史考察方法;③比较分析方法;④系统论、控制论、信息论方法等。(3)法学自身的研究方法:①价值分析方法;②法律解释方法;③逻辑推理方法④法规汇编、法典编篡方法;⑤语义分析方法。此外,法学研究时,还积极借鉴其他具体科学研究方法,比如,生物学方法、心理学方法、物理学方法、文献检索法等等。[研究结论]本文的研究结论如下:(1)中医药标准化理论体系正处在构建中,亟待完善;(2)我国中医标准化工作和中药标准化工作不是同步开展的,我国中药标准化工作比我国中医标准化工作开展的要早一些,也一直走在中医标准化工作的前面。目前,我国中医标准化工作还处在发展阶段,中药标准化工作已进入全面发展提高阶段:(3)中医国际标准化活动与中药国际标准化活动的开展也不是同步的,与中医国际标准化活动相比,中药国际标准化活动进展的要缓慢一些。目前,中医国际标准化工作整体水平还较低,还只是处在发展阶段初期;中药国际标准化活动还只是处在中药材的国际标准创制阶段;(4)我国中医药标准化工作中确实存在一些亟需解决的问题。中医药标准化工作中存在的问题,既有实体问题,也有程序问题,这些实体和程序问题的存在是法学支撑作用得以发挥的现实基础和依据;(5)以法学维度研究中医药标准化问题对解决我国目前中医药标准化工作中存在的问题大有作为。法的方法、法的价值、法的作用、法的运行和法的体系对解决中医药标准化问题提供了法学支撑,为中医药标准化问题的解决给予了法学应对;(6)中医药标准化问题的法学研究具有十分重要的理论意义和现实使用价值,问题研究前沿,思维角度独特,创新性强。[研究价值和意义]本课题的研究价值和意义如下:(1)中医药标准化问题的法学研究对解决中医药标准化问题具有重要支撑作用;(2)对更好地保障中医药预防治疗保健养生水平的提高、保障中医药科技创新和学术水平的提高、保障中医药管理水平的提高、保障中医药产业发展、规范中医药市场秩序、保障中医药国际贸易发展、提高中医药产品的国际竞争力、保障中医药现代化的顺利进行等方面具有积极参考价值和借鉴意义;(3)对加强中医药管理、临床、科研、教育和产业诸方面的标准化建设都具有促进和支撑作用;(4)对构建中医药标准化法律法规体系,加强中医药标准化法治建设具有现实和理论意义。[创新点]本文的创新点如下:(1)首次以法学的思想、观点和方法研究了中医药标准化现状、问题和问题的法学应对;(2)首次对国内、国际中医药标准化的发展阶段进行了划分;(3)对构建中医药标准化理论体系做了一些创造性的探索;(4)创造性地提出了构建中医药标准化法律法规体系的多项实质性建议。更多还原

【Abstract】 Research of Science of Law on Standardization Problem of Traditional Chinese Medicine【Background】Standard refers to a normative document,established by consensus and approved by a recognized body for common and repeated use,aimed at the achievement of the optimum degree of order in a given context Standardization refers to activities about clauses established accouding to actual and potential problems for common and repeated use, aimed at the achievement of the optimum degree of order in a given context Standardization of traditional Chinese medicine(TCM) plays an important role in some aspects such as promoting academic development of TCM,improving clinical curative effect of TCM, enhancing administration of TCM according to law,speeding up TCM to meet the world and accomplishing modernization of TCM.However,because of particularity and complexity of TCM,in the probe and development of standardization work of TCM,there are some outstanding problems,among which some problems of urgent requirement of standards and norms exist in itself of standardization work of TCM.System of laws and regulations of TCM standardization in force is fairly imperfect,present rule construction of TCM standardization by law remains fairly weak.Thus,if standardization of TCM really,practically and commendably produces a marked effec,it need solve outstanding problems of urgent solution required mentioned above in theory and practice.In order to solve these outstanding issues, research of science of law on standardization problem of TCM can provide some important thread,methods,path and countermeasure.【Objective】Research objective of this subject is to provide support of science of law in order to ensure healthy development and action of each aspect and component element in standardization work of TCM,so as to ensure that the fundamental effect of technological support of TCM standardization which should be originally produced in the all-round rejuvenation and sustainable development of TCM cause,can be smoothly and effectively realized.【Methods】This subject mainly adopts research methods of science of law.Research methods of science of law have three levels,that is,(1) Materialistic dialectics which has generally guidance significance;(2) Research methods of general science:①Methods for social investigation;②Historical exploration method;③Comparative and analytical method;④Methods of system theory,cybernetics and information theory etc.;(3) Research methods of science of law itself:①Method for value analysis;②Method for interpretation of law;③Method for logical reasoning;④Methods for corpus of the laws and regulations and codification;⑤Method for semantic analysis. In addition,science of law also actively draws on the experience of research methods of other specific sciences,for instance,biological method,psychological method,physical approach and method for literature retrieval etc.【Conclusions】Research conclusions of this dissertation are as follow:(1) Theory system of TCM standardization is being constructed,and urgently requires to be perfected;(2) In our country,standardization work of Chinese medicine and that of traditional Chinese drug are not synchronized.Compared to standardization work of Chinese medicine, that of traditional Chinese drug carried out earlier,and has been in the ahead of standardization work of Chinese medicine.At present,standardization work of Chinese medicine of our country is in the stage of development,that of traditional Chinese drug has gotten in the stage of overall development and elevation;(3) International standardization of Chinese medicine and that of traditional Chinese drug are also not synchronous.Contrast with international standardization of Chinese medicine,that of traditional Chinese drug evolves slowlier.For the time being,total level of international standardization of Chinese medicine remains low,and is just in the initial stage of development;That of traditional Chinese drug is merely in the creation stage of international standard of Chinese crude drug;(4) There are really some problems to urgently require to solve in the standardization work of TCM of our country.Problems existed in the standardization work of TCM are procedural problems as well as substantial problems,existence of these problems is actual fundament and evidence which the support effect of science of law can be produced;(5) Researching standardization problems of TCM by means of science of law can provide plenty of room for development for solving problems existed in the present TCM standardization of our country.Research methods of science of law,value of law,function of law,operation of law and system of law provided the support and countermeasures of science of law for solving the problems of TCM standardization;(6) Research of science of law on standardization problem of TCM has a very important theoretical significance and actual use value,and its issue research advanced,view angle unique and groundbreaking powerful.【Value and Significance】Value and significance of this subject are as follow:(1) Research of science of law on standardization problem of TCM has an important support function for solving standardization problem of TCM;(2) It has an active value to refer and significance to draw on in such aspects as better ensuring elevation of level of prevention,treatment,health care and health preserving of TCM, ensuring innovation of science and technology of TCM and elevation of academic level of TCM,ensuring elevation of management level of TCM,ensuring industry development of TCM and standardization of market order of TCM,ensuring international trade development of TCM and enhancement of international competition capabilities of TCM products and ensuring modernization of TCM to proceed smoothly etc.;(3) It has promotion and support function for strengthening the standardization construction of some aspects of TCM such as management,clinic,scientific research, education and industry;(4) It has an actual and theoretic significance for constructing the system of laws and regulations of TCM standardization and reinforcing rule construction by law of TCM standardization.【Groundbreaking】This dissertation brings new ideas as follow:(1) It researched current situation,issues and countermeasures of science of law of issues of TCM standardization by means of thought,viewpoint and methods of science of law for the first time;(2) It divided developmental stage of TCM standardization internal and international for the first time;(3) It attempted to undertake some creative exploration for constructing theory system of TCM standardization;(4) It creatively gives many substantial recommendations for constructing the system of laws and regulations of TCM standardization.更多还原