中药配方颗粒质量控制的研究进展  

Research progress on quality control of Chinese medicine formula granules

作　　者：韩子璇 陶晓倩 程岚[1] 张纯刚 HAN Zixuan;TAO Xiaoqian;CHENG Lan;ZHANG Chungang(College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116620,China;Department of Pharmacy,Changzhi Medical College,Changzhi 046000,China;Qimeng Co.,Ltd.,Chifeng 024330,China)

机构地区：[1]辽宁中医药大学药学院,辽宁大连116620 [2]长治医学院药学系,山西长治046000 [3]祈蒙股份有限公司,内蒙古赤峰024330

出　　处：《沈阳药科大学学报》2024年第7期847-854,共8页Journal of Shenyang Pharmaceutical University

基　　金：国家重点研发计划(2018YFC1706903);内蒙古自治区科技重大专项(2021ZD0017);辽宁省自然科学基金指导计划项目(2019-ZD-0968);中医脏象理论及应用国家教育部重点实验室一般项目(zyzx1809);沈阳市中青年科技创新人才项目(RC200204)。

摘　　要：随着中药配方颗粒试点工作宣告结束、部分品种中药配方颗粒的国家标准正式发布,中药配方颗粒正式进入“标准化”的新时代。在中药配方颗粒快速发展的过程中,如何有效对其进行质量控制一直是众多学者研究的重点。文章以质量标准的现状为切入点,分析质量标准难以建立的主要问题,并通过文献查阅总结目前中药配方颗粒的质量控制模式及未来发展的新思路,为推动中药配方颗粒的国际化、标准化发展提供参考。After the completion of the pilot work of Chinese medicine formula granules and the release of national standards,Chinese medicine formula granules have entered the era of"standardization".In the process of rapid development of Chinese medicine formula particles,how to effectively control the quality of formula particles has been the focus of scholars′research.The article took the current status of quality standards as the breakthrough point,analyzed the main problems that were difficult to establish quality standards,and summarized the current quality control mode of Chinese medicine formula granules and new ideas for future development through reviewed literatures.The present review provides reference for promoting the internationalization and standardization of Chinese medicine formula granules.

关 键 词：中药配方颗粒 质量标准 质量控制 多指标成分 生物评价 

分 类 号：R28[医药卫生—中药学]