微生物检定法测定庆大霉素普鲁卡因胶囊中庆大霉素含量的不确定度分析

目的:分析采用微生物检定法测定庆大霉素普鲁卡因胶囊中庆大霉素含量的不确定度以提高测定结果的准确性和可靠性。方法:根据《测量不确定度评定与表示》(JJF1059-1999)等中的有关规定,对该方法测定中各影响因素包括抑菌圈直径、抑菌圈测量仪、试验设计、标准品和供试品(称量、平均装量、纯度、稀释)等进行考察。确定主要影响因素及汇总得到扩展不确定度等。结果:量化了各分量的相对标准不确定度,并计算出总合成标准不确定度,得出扩展不确定度为2.98%;庆大霉素的含量为(88.41±2.98)%。主要影响因素为试验设计、抑菌圈直径和供试品平均装量等。结论:通过分析各分量的相对标准不确定度的大小来优化实验,严格规范操作,可使测定结果更加可靠。

Analysis of the Uncertainty of Gentamycin Content in Gentamycin Sulfate and Procaine Hydrochloride Capsules by Microbiological Method

OBJECTIVE： To analyze the uncertainty on the content determination of gentamycin in Gentamycin sulfate and procaine hydrochloride capsules by microbiological method. METHODS： According to Evaluation and Expression of Uncertainty in Measurement （JJF 1059-1999）, the influential factors of the method, including inhibition zone diameter, inhibition zone detector, experiment design, substance control and test sample （measurement, average quantity, purity and dilution）, were investigated. The main influential factors were determined and the expanded uncertainty was summarized. RESULTS： The relative standard uncertainty was obtained and combined standard uncertainty was calculated. The expanded uncertainty was 2.98% with gentamycin content of （88.41 ± 2.98）%. The main influential factors were experiment design, inhibition zone diameter and average quantity of test sam- ple. CONCLUSION： The more reliable result of the measurement could be obtained when the measurement has been optimized by magnitude analysis of all standard uncertainties and standard operation has been carried out.