2017~2019年我国大陆各省市自治区药品抽检不合格结果分析

Analysis of the Results of Unqualified Drug Sampling and Testing in Various Provinces,Municipalities and Autonomous Regions in China's Mainland from 2017 to 2019

收集整理我国2017~2019年期间大陆各省、自治区和直辖市药监部门发布的不合格药品信息,对不合格药品生产地域、种类、抽样环节、不合格项目等进行统计分析。发现在12384批次不合格药品中,不合格药品主要来源于经营环节(50.74%)和使用环节(42.81%);产地排名前三的为安徽(22.34%)、江西(10.05%)和河北(7.99%);品种主要是中药材及饮片(74.04%);不合格项目中检查项(46.31%)主要涉及中药材及饮片的总灰分/酸不溶性灰分、中成药的装量/重量差异、化学药的可见异物和抗生素的有关物质,以此为药品监督管理监督抽检工作提供参考。

In order to provide reference for drug administrations to focus on the key points and difficulties in drug supervision,information were collected on unqualified drugs released by drug supervision and administration bureaus of various provinces,autonomous regions and municipalities directly under the Central Government of China's Mainland from 2017 to 2019.The data were statistically analyzed mainly on production sources and types of unqualified drugs,sampling locations and unqualified items.Among the 12,384 batches of unqualified medicines,they were mainly sampled from locations of management(50.74%)and use(42.81%);produced in Anhui(22.34%),Jiangxi(10.05%)and Hebei(7.99%);found as Chinese medicinal materials and prepared slices(74.04%);and failed in items of inspection(46.31%)and property(45.13%).The unqualified inspection items were mainly the total ash and acid-insoluble ash in Chinese medicinal materials and prepared slices,the difference of content/weight in Chinese patent medicines,the visible particles in chemical medicines and the related substances in antibiotics.The drug supervision and administration departments should strengthen supervision,formulate and improve drug quality standards,and ensure the quality and safety of drugs.