头孢氨苄片溶出度测定不确定度分析

头孢氨苄片溶出度测定不确定度分析

刘云飞,杨利红,娄志红,于佳

黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所

收稿日期:2015-03-01 修回日期:2015-04-11 出版日期:2015-04-25 发布日期:2015-04-25

The Analysis of Measurement Uncertaintyin the Dissolution Rate of Cefalexin Tablets

娄志红 and 于佳

heilongjiang institute for food and drug control,,heilongjiang institute for food and drug control,heilongjiang institute for food and drug control

Received:2015-03-01 Revised:2015-04-11 Online:2015-04-25 Published:2015-04-25

摘要/Abstract

摘要： 目的：对头孢氨苄片溶出度测定不确定度进行分析和评价。方法：按照中国药典2010年版收载的方法,测定头孢氨苄片溶出度,找出影响不确定度的因素,并计算不确定度分量,基于不确定度测定结果进行风险评估。结果：本次试验溶出度测定结果平均值为80.4%,其扩展不确定度为1.4%(k=2),溶出度测定的合格率为69.6%。结论：当实验结果处于临界值时,对测定结果进行不确定度分析和评估,保证测定结果的科学性和合理性。

Abstract: Objective To evaluate uncertainty in the dissolution rate of cefalexin tablets. Method according to recorded 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 of, the risk was assessed. Result The average dissolution rate was 80.4%, and expanded uncertainty was 1.4% (k=2). The qualified rate of the dissolution rate was 22.1%. Conclusion When the results were in a critical value, uncertainty was analyzed and evaluated to ensure the scientificity and rationality of the results.

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]. .

娄志红 and 于佳. The Analysis of Measurement Uncertaintyin the Dissolution Rate of Cefalexin Tablets[J]. .