2017年至2021年上海市药品质量抽检不合格数据分析  

Analysis of the Results of Unqualified Drug Sampling and Testing in Shanghai from 2017 To 2021

作　　者：郭丹 杨洋 史岚 岳剑锋 殷佳玲 王林波 GUO Dan;YANG Yang;SHI Lan;YUE Jianfeng;YIN Jialing;WANG Linbo(Shanghai Institute For Food and Drug Control,Shanghai 201203,China;Shanghai Drug Administration,Shanghai 200233,China)

机构地区：[1]上海市食品药品检验研究院,上海201203 [2]上海市药品监督管理局,上海200233

出　　处：《药品评价》2023年第1期10-13,共4页Drug Evaluation

基　　金：上海市药品监督管理局立项研究课题(LX-2022-15)。

摘　　要：目的通过统计分析2017年至2021年上海市药品质量抽检情况,为药品质量抽检工作提供参考和建议。方法采用数据统计软件对2017年至2021年上海市药品监督管理局发布的药品质量抽检通告中不合格数据进行统计。结果2017年至2021年上海市药品质量抽检样品约5.8万件,有588件不合格。其中经营环节中的药房和使用环节中的营利性医疗机构不合格数量较多;中药饮片检出不合格最多;不合格项目主要为性状、检查、炮制和含量测定。结论上海市药品质量年度抽检不合格数量整体呈下降趋势,但仍需加强对经营环节和使用环节的抽检力度;加大对中药饮片的抽检力度;针对不合格品种和项目开展专项抽检,提高抽检的靶向性,确保药品质量安全。Objective Through statistical analysis of the situation of drug quality sampling and testing in Shanghai between 2017 and 2021,it provides references,basis and countermeasures for drug sampling and testing.Methods The data of the unqualified drug sampling and testing by the Shanghai Administration from 2017 to 2021 were statistically analyzed using data statistics software.Results From 2017 to 2021,Shanghai drug supervision sample inspection batches were about 58000,with 588 batches of unqualified drugs in the five years.Among them,there were a large number of unqualified pharmacies in the operation link and profit-making medical institutions in the use link;the most unqualified pieces of Chinese herbal medicines were detected;the unqualified items mainly include character,inspection,processing and content determination.Conclusion The number of unqualified drugs in the annual sampling inspection of drug quality in Shanghai is on the decline as a whole,but it is still necessary to strengthen the sampling inspection of the operation and use links;strengthen the sampling inspection of Chinese herbal medicines;carry out special sampling inspection for unqualified varieties and projects to improve the targeted of sampling inspection and ensure the quality and safety of drugs.

关 键 词：药用制剂 质量控制 药品质量抽检 不合格数据 统计分析 

分 类 号：R95[医药卫生—药学]