2014年至2019年马鞍山市药品监督抽检情况与质量分析

Surveillance and Quality Analysis of Drug Sampling in Ma′anshan from 2014 to 2019

目的为药品监管部门的监督抽检工作提供参考。方法以检验报告书为依据,统计安徽省马鞍山市食品药品检验中心2014年至2019年药品监督抽检结果,并对不合格样品进行分析。结果该中心6年完成药品抽检任务5380批,共发现不合格样品71批,不合格率为1.32%;按照生产企业所在省份统计,不合格样品批数最多的为河南;按抽样环节分析,使用单位的样品不合格率最高,为1.65%;按抽检种类分析,中药材及饮片样品的不合格率最高,为3.65%。结论2014年至2019年,该中心抽检的药品整体质量情况良好,中成药、中药材及饮片的不合格率较高,质量有待提高;建议药品监管部门加大抽检力度,完善质量标准、提高重视程度、加强抽样队伍建设和信息共享,确保市场药品质量。

OBJECTIVE To analyze the quality of sample inspection of drug supervision in Ma′anshan food and drug inspection center from 2014 to 2019,so as to provide reference for drug supervision departments.METHODS Based on the inspection report,drug supervision and sampling results in center in the past six years were statistically summarized and unqualified samples were analyzed.RESULTS The overall spot check was in good condition.Quality of essential drugs and drugs produced by enterprises was stable.Most of the unqualified drugs were Chinese herbal medicines and Chinese herbal pieces.CONCLUSION Departments at all levels should strictly supervise and strengthen the special spot check of Chinese patent medicine,Chinese herbal medicine and Chinese herbal pieces to ensure the quality of drugs in the market.