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中药质量标志物(Q-Marker):中药产品质量控制的新概念

刘昌孝1 陈士林2 肖小河3 张铁军1 侯文彬1 廖茂梁1

(1.天津药物研究院新药评价研究中心现代中药研究中心, 天津 300193)
(2.中国中医科学院中药研究所, 北京 100700)
(3.中国人民解放军第三〇二医院全军中药研究所, 北京 100039)

【摘要】为促进中医药产业健康发展,完善质量标准体系,健全以《中国药典》为核心的国家药品标准体系,提升中药及产品质量标准,在研究现有质量评价与控制方法及存在问题的基础上,提出中药质量标志物的新概念。在此基础上从影响中药质量的因素和次生代谢物的因素、中药产品的质量和质量标准与监管存在的问题、中药质量的物质基础的确定、中药质量标志物的定义、研究方法及其在质量评价中的应用等方面与同行们共同讨论,并愿此概念引起同行共鸣。

【关键词】 中药;制剂;药用资源;药典;质量管理;质量标志物;质量标准;一测多评;次生代谢物;

【DOI】

Quality markers of Chinese medicinal herbs: a new concept of quality control for Chinese herbal products

LIU Chang-xiao1 CHEN Shi-lin2 XIAO Xiao-he3 ZHANG Tie-jun1 HOU Wen-bin1 LIAO Mao-liang1

(1.Research Center for New Drug Evaluation, Research Center for Modern Chinese Medicines, Tianjin Institute of Pharmaceutical Research, Tianjin 300193)
(2.Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700)
(3.China Military Institute of Chinese Medicine, Integrative Medical Center, 302 Military Hospital of China, Beijing 100039)

【Abstract】To promote the healthy development of traditional Chinese medicine and herbal industry, improve the quality standard system, strengthen the national pharmaceutical standard system centered on Chinese Pharmacopoeia, and elevate the quality standards of Chinese medicinal herbs and herbal products, a new concept of the quality markers of Chinese medicinal herbs was proposed on the basis of analyzing the existing methods for quality assessment and current problems. Furthermore, discussions were held from the following aspects: factors that affect the quality of Chinese medicinal herbs and secondary metabolites, the quality of Chinese herbal products and the problems about quality standards and regulation, determination of the material basis of Chinese medicinal herbs, and the definition and research methods of the quality markers of Chinese medicinal herbs and the application of the quality markers in quality assessment, with the hope of stimulating peer resonation.

【Keywords】 Chinese medicinal herb; preparation; medicinal resource; pharmacopoeia; quality administration; quality marker; quality standard; quantitative analysis of multi-components by single marker; secondary metabolites;

【DOI】

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This Article

ISSN:0253-2670

CN:12-1108/R

Vol 47, No. 09, Pages 1443-1457

May 2016

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Article Outline

Abstract

  • 1 Factors that affect the quality of Chinese medicinal herbs
  • 2 The quality of Chinese herbal products and the problems about quality standards and regulation
  • 3 Determination of the material basis of Chinese medicinal herbs and the evidence underlying the proposition of Q-markers
  • 4 The basic concept of Q-markers for Chinese medicinal herbs and its application in quality assessment
  • 5 Research examples
  • 6 Discussion
  • References