2008—2021年国家药品抽检中成药质量分析  

Quality Analysis of Chinese Patent Medicines Based on 2008—2021 National Drug Sampling Inspection

作　　者：刘静[1] 于健东[1] 朱嘉亮[1] 王翀[1] 朱炯[1] 戴忠[1] 马双成[1] LIU Jing;YU Jian-dong;ZHU Jia-liang;WANG Chong;ZHU Jiong;DAI Zhong;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1期9-14,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(以下简称国抽)作为我国对上市后药品监管的重要手段,在药品质量评价与监管等方面发挥了重要作用。2008—2021年,全国共抽检中成药品种672种、共计101715批样品,抽检品种与剂型多样,覆盖范围广。综合分析显示,历年标准检验合格率高,整体呈现稳中向好的趋势;探索性研究揭示存在一些质量问题,梳理并归纳这些问题与安全性、真实性、有效性、均一性相关;同时,分析、总结了国抽在中成药质量标准与评价体系建设方面取得的成果,并在此基础上提出了一些思考与建议,以期能为今后国抽工作提供借鉴。National drug sampling inspection is an important means of post-marketing drug supervision in China,and it plays a significant role in many aspects such as drug quality evaluation and supervision.From 2008 to 2021,672 varieties of Chinese patent medicines were sampled and inspected nationwide,involving 101715 batches of samples.Both varieties and dosage forms were diverse,with a wide clinical application range covered.The comprehensive analysis showed that the pass rate of standard inspection over the years was high,and the overall trend tended to stability and improvement.Exploratory research revealed some quality problems that were found to be related to safety,authenticity,effectiveness,and uniformity.Meanwhile,the achievements of national drug sampling inspection in quality control standards and evaluation system construction of Chinese patent medicines were summarized.Additionally,some thoughts and suggestions on national drug sampling inspection were put forward to provide references for the further national drug sampling inspection.

关 键 词：国家药品抽检 中成药 质量 安全 真实 有效 

分 类 号：R286[医药卫生—中药学]