中药质量标志物（Q-Marker）中药产品质量控制的新概念.PDFVIP

中草药 Chinese Traditional and Herbal Drugs 第 47 卷 第 9 期 2016 年 5 月 ·1443· ·专 论· 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 中图分类号：R284；R288 文献标志码：A 文章编号：0253 - 2670(2016)09 - 1443 - 15 DOI: 10.7501/j.issn.0253-2670.2016.09.001 A new concept on quality marker of Chinese materia medica: Quality control for Chinese medicinal 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, China 2. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China 3. China Military Institute of Chinese Medicine, Integrative Medical Center, 302 Military Hospital of China, Beijing 100039, China Abstract: To promote the healthy development of pharmaceutical industry, improve the quality standard system, core of national pharmacopoeia standards, and product quality standards of Chinese materia medica (CMM), we analyzed the existing quality assessment methods and problems on the proposed new concept on Chinese medicine quality markers. On this basis, the factors affecting the quality of CMM and secondary metabolites, herbal product quality and quality standards and regulatory problems in the quality of the material basis of CMM to determine the definition of quality markers of CMM, and research methods in terms of quality evaluation of applications to discuss with colleagues. For a common goal, we would like to respond to this concept can l