2011年非诺贝特制剂评价性抽验结果与质量评价

Sampling Results and Quality Assessment of Fenofibrate Preparation in 2011

目的评价非诺贝特制剂的质量现状及存在问题。方法按照江苏省评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果对非诺贝特制剂的质量现状进行评价。结果检测显示98批样品的重量差异、崩解时限/溶出度、有关物质和含量测定均符合规定。结论该品种制剂质量状况总体评价良好,现行检验标准可行,但探索性研究显示,现行质量标准仍存在不足,建议增加溶出度测定时间。

Objective To evaluate the quality status of fenofibrate preparation and exsisting problems.Methods According to the general requirements of Jiangsu province assessment programs in 2011,use statutory testing methods and combine with the exploratory research to examine samples,evaluate the quality status of fenofibrate preparation by statistical analysis of the results.Results In 98 batches of samples,all products quality can meet the current standards（100%） in terms of weight variation,disintegration time,dissolution,related substances and determination of content.Conclusion At present the preparation quality is generally good.But exploratory research shows that current standards are defective,the dissolution assay time is suggested to be added.