中国药物评价Issue(2)：76-78,3.
头孢氨苄片溶出度测定不确定度分析
Analysis of Measurement Uncertainty in the Dissolution Rate of Cefalexin Tablets
刘云飞 1杨利红 1娄志红 1于佳1
作者信息
- 1. 黑龙江省食品药品检验检测所，黑龙江哈尔滨150001
- 折叠
摘要
Abstract
Objective: To evaluate uncertainty in the dissolution rate of cefalexin tablets.Methods: According to record the method in China pharmacopoeia 2010 , dissolution rate of cefalexin tablets was examined.Factors influencing uncertainty were found out and each part uncertainty was calculated.Based on the determination results of uncertainty, the risk was assessed.Results:The average dissolution rate was 80.4%, and expanded uncertainty was 1.4%( k=2).The qualified rate of the dissolu-tion rate was 69.6%.Conclusion:When the results were in a critical value, uncertainty was analyzed and evaluated to ensure the scientificity and rationality of the results.关键词
头孢氨苄片/溶出度/不确定度/扩展不确定度Key words
Cefalexin tablets/Dissolution/Uncertainty/Expanded uncertainty分类
医药卫生引用本文复制引用
刘云飞,杨利红,娄志红,于佳..头孢氨苄片溶出度测定不确定度分析[J].中国药物评价,2015,(2):76-78,3.
