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

作　　者：刘云飞 杨利红 娄志红 于佳 

机构地区：[1]黑龙江省食品药品检验检测所,黑龙江哈尔滨150001

出　　处：《中国药物评价》2015年第2期76-78,共3页Chinese Journal of Drug Evaluation

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。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 

分 类 号：R927.1[医药卫生—药学]