中药配方颗粒质量控制研究进展  

Research Progress on Quality Control of Chinese Medicine Formulation Granules

作　　者：巴楠楠 郭朝晖 朱旭江 何怀情 Ba Nannan;Guo Chaohui;Zhu Xujiang;He Huaiqing(College of Pharmacy,Gansu University of Chinese Medicine,Lanzhou 730000,China;Gansu Institute of Drug Inspection,Lanzhou 730000,China)

机构地区：[1]甘肃中医药大学药学院,甘肃兰州730000 [2]甘肃省药品检验研究院,甘肃兰州730000

出　　处：《亚太传统医药》2024年第10期216-225,共10页Asia-Pacific Traditional Medicine

基　　金：甘肃省药品检验研究院:古代经典名方金水六君煎制剂开发项目(SSCJG-YP-A202201);兰州市中药配方颗粒研究推广实训基地项目(2019-1-127)。

摘　　要：中药配方颗粒作为传统饮片的补充,顺应了中药市场的需求,丰富了中药饮片类型、简化了用药方式,提供了疗效稳定、质量均一的中药产品。是对传统中医药学的弘扬和发展。随着质量控制研究的深入及国家和各省级中药配方颗粒质量标准的不断完善,使中药配方颗粒得到了迅速推广应用。通过对中药配方颗粒的相关文献进行归纳,总结了中药配方颗粒的生产工艺研究进展,原料药材、中间产物及成品的质量控制,标准汤剂的制备及评价方法,质量控制评价标准,有害物质残留等,还对中药配方颗粒存在的不足进行了论述,旨在促进中药配方颗粒的高质量发展。As a supplement to traditional decoction pieces,TCM formula granules conform to the needs of the TCM market,enrich the types of TCM decoction pieces,simplify the way of medication,and provide TCM products with stable curative effect and uniform quality.It is the promotion and development of traditional Chinese medicine.With the deepening of quality control research and the continuous improvement of the national and provincial quality standards of Chinese medicine formula particles,the Chinese medicine formula particles have been rapidly popularized and applied.By summarizing the related literature of Chinese medicine formula granules,the research on the production technology of Chinese medicine formula granules was summarized.Quality control of raw materials,intermediates and finished products;Preparation and evaluation method of standard decoction;Quality control evaluation research;In order to promote the development of Chinese medicine formula granules,harmful substance residues and deficiencies exist.

关 键 词：配方颗粒 质量控制 生产工艺 质量控制评价 有害物质残留 

分 类 号：R283[医药卫生—中药学]