摘要
目的 为药品监管部门的监督抽检工作提供参考。方法 统计陕西省食品药品监督检验研究院2016年至2018年省级药品抽检结果,并对不合格样品进行分析。结果 该院3年完成省级药品抽检4714批次,共发现不合格样品36批次,不合格率为0.76%;按抽样来源分析,经营企业的样品不合格率最高(0.49%~1.33%);按药品种类分析,中药材及饮片的样品不合格率最高(3.12%~6.11%);按药品剂型分析,饮片的样品不合格率最高(3.12%~6.11%)。结论 2016年至2018年,该院省级药品抽检整体质量状况良好,其中中药材及饮片的不合格率较高,质量有待提高;建议药品监管部门提高重视程度、加大抽检力度、创新检验方法、完善质量标准,切实维护药品质量安全和行业健康发展。
Objective To provide reference for supervision and sampling inspection work.Methods The results of provincial-level drugs in Shaanxi Institute of Food and Drug Control from 2016 to 2018 were statistically summarized and unqualified samples were analyzed.Results In those 3 years,a total of 4714 batches of provincial-level drug sampling tests were completed,with 36 batches of unqualified samples,and the unqualified rate was 0.76%.According to the analysis of sampling sources,the unqualified samples of enterprises were the highest,with the unqualified rate of 0.49%-1.33%.According to the analysis of drug types,the unqualified samples of Chinese medicinal materials and prepared slices were the highest,with the unqualified rate ranging from 3.12%-6.11%.According to the analysis of drug dosage form,the unqualified sample of prepared slices was the largest,with the unqualified rate of 3.12%-6.11%.Conclusion The overall quality of provincial-level drug sampling in 2016-2018 is good,among which the quality of Chinese medicinal materials and decoction pieces needs to be improved.It is suggested that the drug regulatory authorities should further improve their ideological understanding,strengthen sampling inspection,innovate inspection methods,improve quality standards,and effectively safeguard the safety of drug quality and the healthy development of the industry.
作者
刘佩
李霞
戴涌
LIU Pei;LI Xia;DAI Yong(Shaanxi Institute of Food and Drug Control,Xi′an,Shanxi,China 710065)
出处
《中国药业》
CAS
2020年第6期58-60,共3页
China Pharmaceuticals
基金
陕西省重点研发计划项目[2018SF-300]。
关键词
省级
药品抽检
药品质量
药品监管
provincial-level
sampling inspection of drugs
drug quality
drug supervision
