摘要
目的:了解目前各省抽检不合格药品情况,掌握不合格药品的质量安全风险点,为药品的监管和抽检提供参考。方法:收集整理国家药品监督管理局网站"公告""药品通告""药品抽检""地方"项下各省2020年1月1日至2021年7月31日期间所有不合格药品相关通告,对不合格药品品种类别、不合格项目、抽样环节进行梳理。结果:发现317批次不合格药品中,不合格品种类型主要是中药材及饮片(230批次,72.6%);不合格项目主要涉及中药材及饮片的性状、含量测定、中成药的装量/重量差异、化学药的溶出度/溶散时限/分散均匀性、有关物质;不合格药品主要来源于经营环节175批次(55.2%)和使用环节120批次(37.9%)。结论:不合格品种类型主要是中药材及饮片。建议加强药品流通使用环节监管与业务指导衔接,生产企业和医疗机构提升质量控制水平,以期更好的保护老百姓的用药安全。
Objective:To understand the situation of sampling unqualified drugs in each province,and to grasp the risk points of quality and safety of unqualified drugs,so as to provide reference for drug supervision and sampling inspection.Methods:Collect and sort out all the relevant notices of unqualified drugs in each province from January 1,2020 to July 31,2021 under the"Announcements""Drug Notices""Drug Sampling"and"Local"on the website of National Medical Products Administration.Sort out the types of unqualified drugs,unqualified items,and sampling procedures.Results:Among the 317 batches of unqualified drugs,the types of unqualified products were mainly Chinese herbal medicines and decoction pieces(230 batches,72.6%);the unqualified items mainly involve the properties,content determinationof Chinese herbal medicines and decoction pieces,loading volume/weight difference of Chinese patent medicine,dissolution/dissolution time limit/dispersion uniformityof chemical drugs,and related substances;the unqualified drugs mainly come from 175 batches(55.2%)in the operation link and 120 batches(37.9%)in the use link.Conclusion:The main types of unqualified varieties are traditional Chinese medicine and decoction pieces.It is suggested that the production,operation and use units enhance the awareness of subject responsibility and enhance the ability to implement subject responsibility.It is suggested that manufacturers and medical institutions improve the level of quality control in order to better protect the drug safety of people.
作者
姚闽
周雷罡
周萍
胡寿荣
徐菲
YAO Min;ZHOU Leigang;ZHOU Ping;HU Shourong;XU Fei(Jiangxi Institute for Drug Control Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
出处
《药品评价》
CAS
2021年第18期1101-1104,共4页
Drug Evaluation
基金
江西省药品监督管理局项目(2019GL02)
江西省中医药中青年骨干人才培养计划[赣中医药科教字(2020)2号]。
关键词
地方抽检
不合格
药品
监管建议
Local sampling
Unqualified
Drugs
Supervision suggestions
