头孢氨苄片溶出度测定不确定度分析

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.