2022年国家药品抽检中成药质量状况分析  

Quality Analysis of Chinese Patent Medicines Based on 2022 National Drug Sampling and Inspection

作　　者：刘静[1] 朱炯[1] 王翀[1] 金红宇[1] 戴忠[1] 魏锋[1] 马双成[1] LIU Jing;ZHU Jiong;WANG Chong;JIN Hong-yu;DAI Zhong;WEI Feng;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国现代中药》2023年第10期2055-2060,共6页Modern Chinese Medicine

基　　金：国家“重大新药创制”科技重大专项(2018ZX09735-006)。

摘　　要：国家药品抽检以问题导向和风险防控为原则,采用标准检验和探索性研究相结合的评价模式,为我国上市后药品监管提供了重要的技术支撑,是保障药品质量与安全的重要措施。2022年,国家药品抽检涉及47个中成药品种,以各品种质量分析报告为基础,分析中成药质量整体状况,对所发现的主要质量问题进行梳理、归纳,并提出相关完善建议,可为中成药质量进一步提升及科学监管提供参考。National drug sampling and inspection adopt a problem-oriented and risk prevention approach,with standard testing combined with exploratory research as an evaluation model,providing crucial technical support for post-market drug regulation in China and constituting an important measure for ensuring drug quality and safety.In 2022,national drug sampling and inspection covered 47 varieties of Chinese patent medicines.Based on quality analysis reports for each variety,an overall assessment of Chinese patent medicine quality was conducted.The main quality problems identified were analyzed and summarized,along with relevant improvement recommendations.This study is expected to serve as a reference for further enhancing the quality of Chinese patent medicine and implementing scientifically sound regulation.

关 键 词：国家药品抽检 中成药 质量 标准 探索性研究 

分 类 号：R286[医药卫生—中药学]