中药质量标志物Q.pdfVIP

·NQR · 中草药 qea 第 QT 卷 第 V 期 OMNS 年 R 月 中药质量标志物 （nJ ）研究：延胡索质量评价及质量标准研究 1 1 1 2 1 3* 张铁军 ，许 浚 ，韩彦琪 ，张洪兵 ，龚苏晓 ，刘昌孝 1. 天津药物研究院 中药现代研究部，天津 300193 2. 天津中医药大学，天津 300193 3. 天津药物研究院 新药评价中心，天津 300193 摘 要：基于提出的质量标志物（Q-marker ）的概念、确定标准及研究模式，以延胡索为范例进行示范性研究，通过对延胡 索化学物质组辨识明确化学物质基础；通过延胡索化学成分生源途径及成分特异性分析明确其化学成分的来源及特异性；通 过药效、药性及药动学研究及其物质基础的相关性分析，明确其主要药效物质基础；并综合研究结果，确定质量标志物。最 后以延胡索乙素、延胡索甲素、黄连碱、巴马汀、去氢延胡索甲素、a- 四氢药根碱及原阿片碱 7 个生物碱为质量标志物， 建立了延胡索多指标成分定量测定及指纹图谱控制方法。 关键词：延胡索；质量标志物；生源途径；特异性；药效；质量控制 中图分类号：R286.02 ；R284 文献标志码：A 文章编号：0253 - 2670(2016)09 - 1458 - 10 alf 10.7501/j.issn.0253-2670.2016.09.002 nn o 1 1 1 2 1 3 ZHANG Tie-jun , XU Jun , HAN Yan-qi , ZHANG Hong-bing , GONG Su-xiao , LIU Chang-xiao 1. Department of Traditional Chinese Medicine, Tianjin Institute of Pharmaceutical Research Co., Ltd., Tianjin 300193, China 2. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 3. Safety and Evaluation Center of the New Drug, Tianjin Institute of Pharmaceutical Research Co., Ltd., Tianjin 300193, China o was taken as an example for demonstration research based on the concept of quality markers (Q-markers), confirmed standards and research modes were proposed by the author. The chemical constituents of o were identified using high performance liquid chromatography/electrospray ionization quadruple time-of-flight mass spectrometry (HPLC/ESI-Q-TOF MS). The source and specificity of chemical constituents were confirmed by analyzing biosynthetic pathway and component specificity. The major effective components were clarified through efficacy, drug property, pharmacokinetic studies, and correlation analysis of chemical constituents. The Q-markers were determined by integrating all