中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 467-470.

• 质量与工艺研究 • 上一篇    下一篇

2012年跌打丸评价性抽验结果与质量评价

李莉, 承晨, 谢文明   

  1. 常州市药品检验所,江苏 常州 213002
  • 收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
  • 作者简介:李莉,女,本科,副主任中药师,中药材及中成药检验分析。

Sampling Results and Quality Assessment of Dieda Pills in 2012

LI Li, CHENG Chen, XIE Wen-ming   

  1. Changzhou Institute for Drug Control, Jiangsu Changzhou 213002, China
  • Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

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摘要： 目的 评价跌打丸的质量现状及存在问题。方法 按现行标准结合探索性研究进行样品检验,统计分析检验结果对跌打丸的质量现状进行评价。结果 检测显示34批样品的重量差异、水分、溶散时限、微生物限度和含量测定均符合规定。结论 该品种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还需进一步完善。

关键词: 跌打丸, 评价性抽验, 质量评价

Abstract: Objective To evaluate the quality status and exsisting problems of Dieda pills. Methods Using statutory testing >Methods combined with the exploratory research to examine samples, the quality status of Dieda pills was evaluated by statistical analysis of the Results. Results In 34 batches of samples, the quality of all products can meet the current standards(100%) in terms of weight variation, disintegration time, water content, microbial limit and determination of content. Conclusion At present, the preparation quality is generally good, but exploratory research shows that current standards are defective.

Key words: Dieda pills, evaluative testing, quality evaluation

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