江苏省中药配方颗粒标准审评现状述评  

Discussion on the Current Situation of Standard Evaluation of Traditional Chinese Medicine Formula Granules in Jiangsu Province

作　　者：周乐 杨立伟 孙骏 ZHOU Le;YANG Li-wei;SUN Jun(Evaluation Center of Jiangsu Drug Administration, Nanjing 210002, China;School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, China)

机构地区：[1]江苏省药品监督管理局审评中心,江苏南京210002 [2]南京中医药大学药学院,江苏南京210023

出　　处：《南京中医药大学学报》2022年第4期355-360,共6页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：江苏省市场监督管理局科技计划项目(KJ21125121)。

摘　　要：近年来,国家及各省级药监部门先后制定并发布了中药配方颗粒标准,据不完全统计,截止到2022年3月底,国家药典委员会先后共发布了201个品种的国家标准,江苏先后共发布了206个品种的省级标准。笔者分别从药材/饮片、标准汤剂、生产工艺、质量标准、标准复核等方面,对江苏省中药配方颗粒标准审评现状进行概述,为中药配方颗粒标准的制定提供指导意义。In recent years,the national and provincial drug regulatory departments have successively formulated and issued the standard of traditional Chinese medicine formula granules.According to incomplete statistics,by the end of March 2022,the national pharmacopoeia committee has successively issued the national standard of 201 varieties,and Jiangsu has successively issued the provincial standard of 206 varieties.This study summarizes the current situation of the standard review of traditional Chinese medicine formula granules in Jiangsu province from the aspects of medicinal materials/decoction pieces,standard decoction,production technology,quality standard and standard review,so as to provide guiding significance for the formulation of the standard of traditional Chinese medicine formula granules.

关 键 词：中药配方颗粒 省级标准 标准汤剂 生产工艺 质量标准 

分 类 号：R288[医药卫生—中药学]