痹祺胶囊研究进展及其质量标志物的预测分析  

Research progress on Biqi Capsule and predictive analysis of its quality markers

作　　者：张星艳 李虎玲[2] 李新 许妍妍 高晶[2] 曾勇[2] 于飞[3] 王玉丽 刘昌孝[2,5] ZHANG Xing-yan;LI Hu-ling;LI Xin;XU Yan-yan;GAO Jing;ZENG Yong;YU Fei;WANG Yu-li;LIU Chang-xiao(Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Research Center for Modem Chinese Medicines,State Key Laboratory of Drug Delivery Technology and Pharmacokinetics,Key Laboratory of Quality Markers of Traditional Chinese Medicine,Tianjin Institute of Pharmaceutical Research,Tianjin 300462,China;Tianjin Key Laboratory of Clinical Drug Key Technology,School of Pharmacy,Tianjin Medical University,Tianjin 300070,China;Key Laboratory of Systems Bioengineering(Ministry of Education),School of Chemistry Engineering and Technology,Tianjin University,Tianjin 300072,China;Research Unit for Drug Metabolism,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]天津中医药大学,天津301617 [2]天津药物研究院现代中药研究中心,释药技术与药代动力学国家重点实验室,中药质量标志物重点实验室,天津300462 [3]天津医科大学药学院,天津市临床药物关键技术重点实验室,天津300070 [4]天津大学化学工程与技术学院,系统生物工程教育部重点实验室,天津300072 [5]中国医学科学院药物代谢新技术创新单元,北京100730

出　　处：《中草药》2021年第9期2746-2757,共12页Chinese Traditional and Herbal Drugs

基　　金：国家自然科学基金重点项目(81430096);国家新药创新项目(2017ZX09301062);天津市科技计划项目(19YFSLQY00110);天津市“项目+团队”重点培养专项(创新类)(XC202030);中国医学科学院医学与健康科技创新工程项目资助(2019-I2M-5-020)。

摘　　要：中药质量控制一直是中药临床需求和产业发展的关键。刘昌孝院士于2016年提出的中药质量标志物(quality marker,Q-Marker)新概念和核心理论,建立了中药质量控制系列共性关键技术,构建了中药质量研究新模式,为中药品种的现代化研究指明了方向。以痹祺胶囊药效学、药动学研究为实例,在Q-Marker理论的指导下,从特有性、可测性、有效性和中药理论关联性等方面对痹祺胶囊的研究进行总结分析,发现士的宁、马钱子碱、甘草苷、丹酚酸B、甘草酸、隐丹参酮和丹参酮IIA可作为该复方的Q-Marker,为痹祺胶囊的质量控制及二次开发提供基础和依据,同时,也为建立痹祺胶囊的全程质量控制及质量可溯源体系奠定良好基础。The quality of traditional Chinese medicine(TCM)has always been an important concern for the clinical needs and industrial development of TCM.The new concept and core theory of quality markers(Q-Marker)of TCM proposed by Academician Changxiao Liu in 2016 has established a series of common key technologies for quality control,built a new model for quality research,and pointed out the direction for modernization research of varieties of TCM.This paper briefly outlines the clinical applications and pharmacological effects of Biqi Capsule(痹祺胶囊),and summarizes and analyzes the research on Biqi Capsule in terms of ingredient specificity,measurability,component validity,and relevance theory of TCM.The results suggested that strychnine,brucine,liquiritin,glycyrrhizic acid,salvianolic acid B,cryptotanshinone and tanshinone IIA can be used as Q-markers for this formula.It provides a basis for quality control and secondary development of Biqi Capsule,and also provides a good basis for the establishment of a full quality control and quality traceability system for Biqi Capsule.

关 键 词：痹祺胶囊 中药 质量标志物 士的宁 马钱子碱 甘草苷 丹酚酸B 甘草酸 隐丹参酮 丹参酮ⅡA 

分 类 号：R284[医药卫生—中药学] R285[医药卫生—中医学]