2010年吡拉西坦制剂评价性抽验结果与质量评价

Sampling Results and Assessment the Quality of Piracetam Preparation

目的评价吡拉西坦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吡拉西坦制剂的质量现状进行评价。结果法定检验显示158批样品中2批(1.3%)不合格,其中1批片剂重量差异项不合格,1批注射液可见异物项不合格。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,但尚有亟待完善之处。

Objective To evaluate the quality status ofpiracetam preparation and exsisting problems. Methods According to the general requirements of Jiangsu Province assessment programs, use statutory testing methods and combine with the exploratory research to examine samples, evaluate the quality status of piracetam preparation by statistical analysis of the results. Results In 158 batch of samples, 2 batch of unqualified（1.3%）, weight difference and particulate matter as the main causes of failure. Conclusions At present the preparation quality is generally good. The current standard is feasible, but there needs to be improved at.