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II_A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 II_A 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.

R284;R285

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）