2021年国家药品抽检中成药质量分析  

Quality Analysis of Chinese Patent Medicines based on 2021 National Drug Sampling Inspection

作　　者：刘静[1] 朱炯[1] 王翀[1] 戴忠[1] 马双成[1] LIU Jing;ZHU Jionga;WANG Chong;DAI Zhong;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国现代中药》2022年第6期947-953,共7页Modern Chinese Medicine

基　　金：中药组分资源及产业公共技术服务平台建设项目(2018ZX09735-006);国家“重大新药创制”科技重大专项(2018ZX09735-006)。

摘　　要：国家药品抽检是目前我国对上市后药品监管的重要手段,自2008年实施以来,在药品监管、质量控制水平提升及质量评价等方面发挥了重要作用。2021年,国家药品评价抽检中成药品种46个,通过认真梳理各品种质量分析报告,对标准检验及探索性研究发现的主要问题进行归纳,对报告反映的中成药整体质量状况进行总结、分析,全面了解市场上相关药品的质量现状,并提出相应建议,为中成药的质量进一步提升提供参考。National drug sampling inspection is an important means of post-marketing drug surveillance in China.Since the implementation in 2008,it plays a significant role in many aspects including drug supervision,improvement of drug quality control and quality evaluation.In 2021,46 varieties of Chinese patent medicines were selected for national drug sampling inspection.This paper thoroughly sorted out the variety quality analysis reports,summarized the main problems found in the standard tests and exploratory research,and analyzed the overall quality status reflected by the reports,which facilitated fully understanding the quality status of relevant drugs in the market.Additionally,corresponding suggestions were put forward.The paper could provide references for further quality improvement of Chinese patent medicines in the future.

关 键 词：国家药品抽检 中成药 质量 

分 类 号：R286[医药卫生—中药学]