中国药物警戒 ›› 2012, Vol. 9 ›› Issue (7): 436-438.

• 药械质量研究 • 上一篇    下一篇

2010年吡拉西坦制剂评价性抽验结果与质量评价

王玲娜, 丁建, 朱菁华, 张晓栋   

  1. 江苏省常州药品检验所,江苏 常州213002
  • 收稿日期:2011-02-22 出版日期:2012-07-10 发布日期:2015-08-07
  • 作者简介:王玲娜,女,本科,主管药师,药物分析与药品质量。

Sampling Results and Assessment the Quality of Piracetam Preparation

WANG Ling-na, DING Jian, ZHU Jing-hua, ZHANG Xiao-dong   

  1. Changzhou Institute for Drug Control of Jiangsu Province, Jiangsu Changzhou 213002, China
  • Received:2011-02-22 Online:2012-07-10 Published:2015-08-07

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摘要： 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。

关键词: 吡拉西坦, 评价性抽验, 质量评价

Abstract: ObjectiveTo evaluate the quality status of piracetam preparation and exsisting problems. MethodsAccording 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. ResultsIn 158 batch of samples, 2 batch of unqualified(1.3%), weight difference and particulate matter as the main causes of failure. ConclusionsAt present the preparation quality is generally good. The current standard is feasible, but there needs to be improved at.

Key words: piracetam, evaluative testing, quality evaluation