摘要
目的建立微生物检定法测定依托红霉素含量的不确定度方法。方法建立数学模型,识别和分析不确定度来源,量化各不确定度分量,计算测量结果的合成不确定度和95%置信区间下的扩展不确定度。结果在95%置信区间下,扩展不确定度为55.28 u·mg^(-1),微生物检定法测定依托红霉素的含量为(891.53±55.28)u·mg^(-1),k=2。结论通过不确定度评定,该方法适用于依托红霉素含量测定的不确定度分析。
OBJECTIVE To establish an uncertainty method for the determination of erythromycin estolate by microbiological assay.METHODS A mathematical model was established to identify and analyze the sources of uncertainty,to quantify each component of uncertainty,and to calculate the combined uncertainty and expanded uncertainty under 95%confidence interval.RESULTS Under the 95%confidence interval,the expanded uncertainty was 55.28 u·mg^(-1),and the content of erythromycin estolate determined by microbiological assay was(891.53±55.28)u·mg^(-1),k=2.CONCLUSION The method was found to be suitable for the uncertainty analysis of the determination of erythromycin estolate content based on the evaluation of uncertainty.
作者
钟海婷
肖娟
王立鹏
ZHONG Hai-ting;XIAO Juan;WANG Li-peng(Ankang Center for Food and Drug Control,Ankang 725000,China)
出处
《海峡药学》
2022年第4期107-111,共5页
Strait Pharmaceutical Journal
关键词
微生物检定法
依托红霉素
不确定度分析
Microbiological assay
Erythromycin Estolate
Uncertainty analysis
