整体法评估药品中需氧菌计数检验结果的不确定度

Uncertainty Estimation of Total Aerobic Microbial Determination of Drugs by Global Approach

目的:建立药品中需氧菌计数检验结果的不确定度评估方法。方法:以咽炎片为例,用整体法分析不确定度来源,参照正交试验方法依据《中华人民共和国药典》2015年版进行需氧菌总数计数,对检验过程中的不确定度进行量化。结果:需氧菌计数结果对数值符合正态分布,计算可得扩展不确定度和需氧菌总数的取值范围。结论:用整体法评估检测结果的不确定度操作简便,结果客观可靠,可用于药品微生物实验室内部质量控制。

Objective:To establish a method for uncertainty estimation of total aerobic microbial test of drugs.Method:Taking Yanyan Tablet for example,the sources of uncertainty in the process of test were analyzed by global approach,the total aerobic microbial amounts were detected according to orthogonal design and Chinese Pharmacopoeia 2015,and the uncertainty in the testing process was quantified.Results:Logarithms of total aerobic amounts conformed to normal distribution.The expanded uncertainty and distribution range of total aerobic microbial amounts could be extended by calculation.Conclusion:Estimation of measurement uncertainty by global approach was simple enough to operate with reliable result and could be used for internal quality control in pharmaceutical microbiology laboratories.