民族药材质量控制技术及标准制定示范性研究  

Demonstration Study on Quality Control Technology and Standard Formulation for Ethno-Medicinal Materials

作　　者：郑健[1] 过立农[1] 鲁静[1] 于江泳 马双成[1] 王海南 ZHENG Jian;GUO Li-nong;LU Jing;YU Jiang-yong;MA Shuang-cheng;WANG Hai-nan(National Institutes for Food and Drug Control;National Medical Products Administration)

机构地区：[1]中国食品药品检定研究院 [2]国家药品监督管理局

出　　处：《中国食品药品监管》2022年第3期34-41,共8页China Food & Drug Administration Magazine

摘　　要：针对民族药材基础研究不足、基原不统一、检测项目不完善的现状,在国家药品监督管理局指导下,中国食品药品检定研究院联合民族省区药品检验部门合作开展民族药材质量控制技术及标准制定示范性研究。通过顶层设计,制定技术指导原则,加强项目管理,进行系统化、规范化和示范性研究,对研究难点问题进行重点阐述分析,建立具有民族药特色的质量控制研究模式,以期加快提高和完善民族药质量标准的建设。In view of the current situation of insufficient basic research on ethno-medicinal materials,inconsistent origin and inadequate testing items,a demonstration study on the quality control technology and standards development for ethno-medicinal materials were performed by the National Institutes for Food and Drug Control (NIFDC) in cooperation with the drug control institutes of ethnic provinces and autonomous regions,under the guidance of the National Medical Products Administration (NMPA).Through top-down design,the research project engaged in formulating technical guidelines,strengthening project management and carrying out systematic,standardized and demonstrative research.The goal is to focus on the research difficulties and establish quality control research models that are unique for ethno-medicine,so as to accelerate and improve development of quality standards for ethno-medicines.

关 键 词：民族药材 质量控制 标准制定 示范性 

分 类 号：R29[医药卫生—民族医学]