• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

• 评价技术与方法 • 上一篇    下一篇

国家评价性抽验复方胺酚烷胺片剂质量分析

王冬,牛玉娟,李清,张瑜   

  1. 大连市食品药品检验所,大连市食品药品检验所,沈阳药科大学,大连市食品药品检验所
  • 收稿日期:2014-01-23 修回日期:2014-02-25 出版日期:2014-04-25 发布日期:2014-04-25

The Quality Analysis of Compound Paracetamol and Amantadine Hydrochloride Tablets

王冬,牛玉娟,李清 and 张瑜   

  1. DaLian Institute for Drug and Food Control,DaLian Institute for Drug and Food Control,Shenyang Pharmacetuics University,Dalian Institute for Food and Drug Control
  • Received:2014-01-23 Revised:2014-02-25 Online:2014-04-25 Published:2014-04-25

摘要: 目的:对2013年国家评价性抽验复方胺酚烷胺片剂质量现状进行分析。方法:对294批样品按照现行标准进行逐项检验,并对检验结果进行统计和分析。结果:有6份样品的溶出度不符合标准规定,不合格率为98%。结论:按照现行检验标准,复方胺酚烷胺片剂质量总体良好,个别企业仍需加强管理和监督。现行标准仍需完善和提高,以控制生产过程,提升药品质量。

Abstract: Objective : To analyze the quality of Compound Paracetamol and Amantadine Hydrochloride Tablets in National Assessment Programs of 2013. Method : Inspected the 294 samples by quality criterions and analyzed the results . Result : 6 batches dissolution failed, the unqualified sample rate was 98%. Conclusions : Most samples qualified the current standards, but a few enterprises needs to improve . The current standard should be perfected to control the drug quality.