微生物检定法测定依托红霉素含量的不确定度分析  

Analysis of Uncertainty in Determination of Erythromycin Estolate by Microbiological Assay

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)

机构地区：[1]安康市食品药品检验检测中心,陕西安康725000

出　　处：《海峡药学》2022年第4期107-111,共5页Strait Pharmaceutical Journal

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.

关 键 词：微生物检定法 依托红霉素 不确定度分析 

分 类 号：R927[医药卫生—药学]