中药整体质量控制标准体系构建的思路与方法  

Strategies for elaboration of comprehensive quality standard system on traditional Chinese medicine

作　　者：吴婉莹[1] 果德安[1] 

机构地区：[1]中国科学院上海药物研究所 中药标准化技术国家工程实验室,上海201203

出　　处：《中国中药杂志》2014年第3期351-356,共6页China Journal of Chinese Materia Medica

基　　金：国家中医药管理局2013年中医药行业科研专项(201307002);中国科学院重点部署项目(KSZD-EW-Z-004-01)

摘　　要：基于中药标准"以我为主,引领国际"的研究目标,阐述了中药质量标准体系构建的科学方法。作者所在实验室多年从事中药质量标准的研究,通过对国内外标准构建方法与思路的学习与实践,提出科学与实用为基本原则,"深入研究,浅出标准"为指导思想,符合中医理论的中药整体质量控制标准体系构建理念。中药标准体系构建主要包括基础研究与标准建立两部分工作,其中深入的基础研究是需要溯本求源,需要全面的药效物质基础及作用机制的深入探讨;同时也对如何浅出科学实用的质量标准,提出了相关建议,包括对照物质,对照图谱以及新的定量分析方法的应用等。Based on the research goal of ＂traditional Chinese medicine standards lead in the international standard-setting＂, scientific strategies for the elaboration of traditional Chinese medicine （TCM） comprehensive quality standard system were introduced. TCM is a complex multi-component system which was used under the guidance of traditional Chinese medical theory. The present paper has put forward the basic principle of ＂deep research and simplified standard＂ to construct the quality standards of TCM. ＂ Deep research＂ refers to systematic, thorough investigations on active constituents and biological mechanisms. On the basis of deep research, ＂simplified standard＂ means to establish a scientific and feasible standard, which should be practical and less complicated, to control the quality of Chinese herbs. Three key issues related to the elaboration of the quality standards are suggested. For reference substances, we propose the research methodology using reference extract to develop the qualitative and quantitative determination methods. Compared with that of using reference compounds, the preparation of reference extract is more accessible, economical and practical. Moreover, compared with reference crude drugs, the reference extract showed better batch-to-batch consistency. For identification, in addition to conventional methods, high performance liquid chromatography （ HPLC）, chemical fingerprints and characteristic chromatogram are proposed, in which more major marker compounds are monitored. And then LC-MS technique is employed to comprehensively analyze and characterize the peaks in the fingerprint. For multi-component quantification, the method of single standard to determine multi-components （SSDMC） is suggested, providing solutions for the lack of reference standards in quality evaluation. The SSDMC method uses a single reference standard to simultaneously determine the content of multiple compounds. In general, the integrate quality control standard of TCM is established based on

关 键 词：中药整体质量控制标准体系 对照提取物 对照图谱 一测多评 

分 类 号：R28[医药卫生—中药学]