硫酸卡那霉素注射液含量测定的不确定度分析

Evaluation of Uncertainty of Determination of Kanamycin Monosulfate for Injection by the Microbiological Method

关键词:  微生物检定法  硫酸卡那霉素注射液  效价  不确定度

Key words:  microbiological method  kanamycin monosulfate for injection  biological value  uncertainty evaluation

摘要:

为研究微生物检定法（管碟法）测定硫酸卡那霉素注射液生物效价试验中各因素对结果的影响，采用不确定度分析，将影响因素归纳为称量、稀释、加样、测定、平行试验，量化各不确定度分量，评估各因素的影响因子。结果表明，牛津杯加样体积对测定结果影响最大，提示试验中应尽可能精确控制加样体积。

Abstract:

To evaluate the uncertainty of determination of kanamycin monosulfate for injection by the microbiological method in Chinese Veterinary Pharmacopoeia (edition 2010), a mathematied model was established to evaluate the factors affecting sample determination. Each component of uncertainty was calculated by analyzing the various variable parameters among the procedures. The combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables. The volume of sample added into Oxford Cup effects result most. As a result, the added volume should be controlled accurately in the test.