中药质量控制技术发展展望  

Prospects of the development of quality control technologies for traditional Chinese medicine

作　　者：梁鑫淼[1] 丰加涛[1] 金郁[1] 郭志谋[1] 徐青[1] 

机构地区：[1]中国科学院大连化学物理研究所,辽宁大连116023

出　　处：《色谱》2008年第2期130-135,共6页Chinese Journal of Chromatography

基　　金：中国科学院知识创新工程重要方向项目(KGCX2-SW-213)

摘　　要：本文从中药产业需求、现代化需求、技术需求、机遇与挑战等方面概括了中药质量控制技术发展的背景;讨论了中药质量控制技术对于提高中药药效和安全性、推动产业发展和推进中药国际化的意义;综述了中药质量控制技术的现状,分析了在过程控制、安全性控制、标准品和对照品制备、指纹图谱技术等方面的不足;提出了中药质量控制技术应重点发展以分离和表征技术为主的中药质量控制关键技术、中药安全性控制技术、中药质量控制标准体系、中药质量控制原创性技术和中药标准品、对照品生产技术,制定技术标准,建立具有中药特色的过程控制和产品质量控制标准。Quality control is one of bottleneck problem limiting the applications and development of traditional Chinese medicines（TCMs）.In recent years,the research on TCMs has already made a great progress.In this review,the background of quality control is discussed from the requirement of TCMs industry,modernization of TCMs,the requirement of techniques as well as opportunities and challenges in the quality control of TCMs.The significance of quality control to improve the efficiency and safety of TCMs,to promote the development of TCMs industry and the globalization of TCMs are also discussed.The status quo of quality control is reviewed,in which the drawbacks of process control,safety control,the preparation of reference compounds and fingerprint in quality control of TCMs were analyzed.In addition,the technological prospects based on modern separation techniques and detection methods for the quality control of TCMs are put forward,including the key techniques of the quality control,the techniques of safety control,the standard systems of the quality control,the innovative techniques,the techniques for the preparation of reference compounds,the establishment of technique standards,etc.

关 键 词：中药 质量控制技术 安全性控制 质量控制标准体系 中药现代化 

分 类 号：O658[理学—分析化学]