一种医院制剂中需氧菌总数不确定度的评定

Uncertainty Evaluation of Total Aerobic Microbial Count in the Hospital Preparation

为保证药品质量,建立药品不确定度的评定方法,以及有效评价检测过程带来的不确定度和检验每个环节引入的误差.根据《中华人民共和国药典》对20份同一批次胸痹通脉丸中的需氧菌总数进行检测,采用《测量不确定度评定与表示》分析其不确定度来源和评定不确定度分量,然后使用合成的方法评定需氧菌总数的不确定度,并确定其置信区间.结果表明,需氧菌总数检测结果合成不确定度为0.0196,扩展不确定度为0.0461,置信区间为180~281cfu/g,检测数据符合正态分布.

To guarantee the quality of drug, the uncertainty evaluation method was designed to evaluate effectively the uncertainty in the examining process and the errors in every test step. The total aerobic microbial count of 20 samples in the same batch of Xiongbitongmai pills were checked under the direction of Chinese Pharmacopoeia. Evaluation and expression of uncertainty in measurements was used to analyze the uncertainty sources and evaluate the uncertainty components. Synthetic method was used to assess the uncertainty of total aerobic microbial count (TAMC) and to make sure the confidence interval. The result showed that the combined uncertainty was 0.019 6;the expanded measurement uncertainty was 0.046 1;the confidence interval of the samples was 180-281 cfu/ g. The examining data was normal distribution.