中成药质量控制研究进展

中成药是我国医药学宝库的重要组成部分，在推动我国医药产业的发展过程中具有不可替代的作用。但是中成药有效成分复杂，药效物质基础不明确，以及单味药材易受品种、产地、加工方法等因素的影响，使得中成药的质量评价成为阻碍中成药走向现代化与国际化的障碍。所谓中成药的现代化就是指用现代化的分析检测手段去解决中成药的质量问题，而中成药的国际化就是指在我国传统中成药知识产权和法律制度的前提下，用国际化的视野和创造性的思维来促进中成药的科技创新，加强与国际之间的交流与合作，达成共识，创建国际化与标准化的中成药质量控制体系。本文从历代药典对中成药质量控制的变化、中成药质量控制的现状分析及存在问题三方面进行了综述，提出了完善中成药质量控制的策略，从而进一步使中成药走向现代化与国际化。

Research Progress on the Quality Control of Chinese Patent Medicine

Chinese patent medicine （CPM） is an important component of the treasure-house of Chinese medicine and pharmacology. It plays an irreplaceable role in the development of China＇s pharmaceutical industry. However, the drawbacks of CPM including the complex of active constituent, uncleamess of therapeutic material basis, as well as the single herb are influenced by variety, origin and processing methods, becoming obstacles for the quality control of CPM. The modernization of CPM is to solve its problems of quality control by modernized analytic methods, and the internationalization of CPM is to establish its international and standard quality control system by international eyesight and creative thinking to promote the innovation of technology, strengthen communication and cooperation, and finally reach a consensus, based on our traditional intellectual property rights and legal institutions of CPM. This article reviews quality control of CPM through changes of Chinese pharmacopoeia in the different historical periods, analysis current situation and exiting problems, and finally proposes methods to improve the quality control of CPM, and further makes it will be modernized and internationalized.