2013-2015年湖北省药品质量监督抽验结果分析

Analysis of the Results of Drug Sampling and Testing in Hubei Province from 2013 to 2015

目的:评价湖北省药品抽验质量情况,为监管部门与药品生产企业提供参考。方法:收集汇总湖北省食品药品监督检验研究院2013-2015年省计划抽验药品检验结果,以现行标准对总体质量状况及不合格样品情况进行统计分析。结果与结论:2013-2015年共完成省计划抽验药品检验7 721批,发现不合格样品333批,占4.3%。不合格产品主要出自经营企业(不合格率为2.8%~9.0%)和医疗机构(不合格率为5.2%~11.7%);从品种看,中药材不合格率最高(12.1%~37.4%)、不合格项目(含量测定、补充检验项目、性状、二氧化硫残留量及灰分等项目)种类最多,药物制剂的质量则相对稳定,不合格项目分布与品种和剂型有关。宏观层面存在现有标准水平参差不齐、抽验资源分配欠合理、行业整体水平较低等问题。建议监管部门整顿药品标准,合理规划抽验工作,加强生产企业源头治理。

OBJECTIVE：To evaluate the quality of sampling drugs of Hubei province,and to provide reference for drug enterprises and supervision department. METHODS：The data obtained by Hubei Institute for Food and Drug Control about provincial drug sampling and testing from 2013 to 2015 were summarized,the overall quality and unqualified items were statistically analyzed according to current standard. RESULTS CONCLUSIONS：The number of total sampling batches was 7 721 and that of the unqualified batches was 333（4.3%）during 2013-2015. Most of the unqualified samples came from distribution units（2.8%-9.0%）and medical institutions（5.2%- 11.7%）. Among all sample types,the herbal medicine has the highest unqualified rate（12.1%-37.4%）,with the largest number of unqualified items（content determination,supplement inspection item,property,residual amount of sulfur dioxide,ash content）. The quality of pharmaceutical preparations is relatively stable,and the unqualified items correlated with drug types and dosage forms. The current issues of provincial drug sampling and testing are the variety of standard levels,unreasonable sampling resource allocation and the low level of the industry. Supervision department is proposed to readjust drug standard,reasonably plan sampling and testing process and strengthen production source controlling.