By the end of 2010, the standardization of Chinese Herb Slices has basically met all legal demands. In particular GMP and China Pharmacopoeia have provided reflected one kind of modification appropriate for Traditional Chinese Medicine. The paper aims to study the standardization process of Chinese Herb Slice industry and to evaluate the impacts of standardization. Archival data from China Economic Information Network and first-hand materials from field work at three Chinese Herb Slice companies are analyzed in this paper. The paper summarized laws, regulations and policies on standardization of Chinese Herb Slices from 1949 and studied the establishment of Chinese Herb Slice industrial standards from the process, participants and performance of the standards perspectives. At the chapter of standard establishment, literature review has found that the previous research of standards of TCM and Chinese Herb Slices mainly focus on the establishment of quality standard and pharmacopoeial standard and the comparison between Chinese and foreign standard. The paper analyzes the process of standard establishment from the point of the Good Manufacturing Practice (GMP) and the pharmacopoeia. And discuss the participants and management system of the standard subsequently. In the chapter of contents of standard, the paper explained necessity of discussing contents of the standard. The contents of standard will change as the ideas and objectives of standard establishment. In addition, the different Chinese and western thinking models will result in different contents of the standard. 1) What is the content of pharmacopoeia standard of Chinese Herb Slices? Which is the guide theory, the TCM theory or western medicine one? 2) The management framework of GMP learned more from the manufacturing characteristics of TCM itself or the management thoughts of manufacture of western medicine? In the chapter of standard performance, data of manufacture of Chinese Herb Slice industry from 2003 to 2011 have showed great improvements in industrial standardization since the establishment. By comparing with detailed process of standard establishment, it revealed that GMP of Chinese Herb Slices and pharmacopoeia (version 2005) impacted the Chinese Herb Slice industry significantly while pharmacopoeia published in 2010 had few influence on the industry. Therefore an additional TCM enterprises field survey was conducted to analysis the actual impact from the perspective of establishment and contents of standard. Finally, in the conclusion chapter, it discusses the influences of the establishment and contents of standard on the performance of standard and suggests expanding enterprises’ participation, contents of standard and regional communication. The limit of this research is mainly compliance problems and the actual execution of the standard, which is also the next research focus.

本文旨在分析作为传统中华医药组成部分的中药饮片产业是如何在历史条 件下发展标准化的。中药饮片虽然历史悠久，但是缺乏确定的炮制过程、确定的 产成品标准和完整的管理过程体系。作为一种传统中药产品，它的实际制造过程 多为定性的语句和经验指导。而在实际标准上，则是省级标准或者企业自行设置 标准。我国从 2002 年开始了自行研制标准的过程。那么标准的建立过程、标准 建立的参与者和标准的绩效成为我们的关注问题。 本文首先通过二手资料总结了从建国以来的标准化法令，再从过程、参与者、 绩效三个方面入手来研究中药饮片产业标准建立的具体情况。 标准的建立一章首先回顾了标准建立的文献。在对标准的文献关于标准建立 的研究进展的讨论之后，本章探讨了前人对中药和中药饮片标准的研究情况。之 前的研究者主要从饮片的质量标准的建立、药典标准的建立和中外标准的比较来 分析饮片标准。作者从标准的重要组成部分 GMP 和药典两个入手对二者的建立 过程进行详细的评述，从标准的参与者和管理体系的角度对标准的建立进行分析。 在标准的内容一章，标准的内容的探讨是必要的。因为内容的差异直接显示 了标准的建立思路和目的。同时中西方思维模式的不同直接反映在标准的内容上， 会产生不同的结果。1）以药典为代表的中药饮片成品标准的内容是怎样的呢？ 是关注了中药饮片传统的中医科学思想还是西医的科学系统在里面发挥了主要 的指导作用？2）而从实际生产入手，GMP 的管理框架的建立是更多的考虑了中 药本身的制造特点还是借鉴了西药制造管理思想呢？ 在标准的绩效一章。本文首先对于标准建立以来（2003 年到 2011 年）的中 药饮片制造工业数据进行了分析。发现中药饮片在标准化之后的这段期间有了巨 大的发展和变化。并通过与标准建立详细过程进行对比，发现中药饮片 GMP 和 2005 版药典从时间上看对于饮片产业结构影响显着，但是 2010 版药典则由于时 间的限制并不明显。所以，本文通过企业调研的数据，从标准的建立和内容的角 度来研究会产生哪些影响。 最后，在总结一章，本文总结了上面三章内容的结论。探讨了标准建立和标准的内容对标准绩效的影响，并提出增加企业参与，增加标准内容和增强区域交 流三个建议。本文的不足和下一步的研究主要集中在标准的依从性问题和标准的 实际执行上。 关键字：中药饮片；产业标准化；生产质量规范（GMP）；中国药典