色谱

• 中药质量控制专栏 • 上一篇    下一篇

中药质量控制技术发展展望

梁鑫淼1 ,丰加涛1,2,金郁1,2,郭志谋1,2,徐青1

  

  1. 1.Dalian Institute of Chemical Physics, the Chinese Academy of Sciences, Dalian 116023, China; 2.Graduate School of the Chinese Academy of Sciences, Beijing 100039, China
  • 收稿日期:2007-12-28 修回日期:1900-01-01 出版日期:2008-03-30 发布日期:1984-06-25
  • 通讯作者: 梁鑫淼

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

LIANG Xinmiao1, FENG Jiatao1,2, JIN Yu1,2, GUO Zhimou1,2, XU Qing1   

  1. 1.Dalian Institute of Chemical Physics, the Chinese Academy of Sciences, Dalian 116023, China; 2.Graduate School of the Chinese Academy of Sciences, Beijing 100039, China
  • Received:2007-12-28 Revised:1900-01-01 Online:2008-03-30 Published:1984-06-25

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。

关键词: 安全性控制, 质量控制标准体系, 质量控制技术, 中药, 中药现代化

Abstract:

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.

Key words: modernization of TCMs
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quality control technology, safety control, standard system of quality control, traditional Chinese medicines (TCMs)