目的:验证荧光染色技术替代中国药典制药用水微生物检验的可行性.方法:根据微生物检验替代方法验证国内外相关法规的要求,以纯化水为对象,开展准确度、精密度(重复性和中间精密度)、专属性、定量限、线性、范围、耐用性等参数的验证研究,并采用统计学方法对各参数验证结果进行分析.结果:本研究中替代方法的准确度、精密度、定量限和范围相较于药典方法无显著性差异;同时替代方法具有良好的专属性、线性及耐用性.结论:本研究为微生物检验替代方法验证提供实际案例及参考.
Objective:To verify the feasibility of alternative fluorescence staining technology for the microbial testing of pharmaceutical water.Methods:According to the requirements of domestic and foreign regulations on alternative microbial testing methods,a validation study was conducted on parameters such as accuracy,precision(repeatability and intermediate precision),specificity,limit of quantification,linearity,range,and robustness with purified water as the study object.Statistical methods were used to analyze the validation results of each parameter.Results:There was no significant difference in the accuracy,precision,quantification limit,and range of alternative methods compared to the pharmacopoeia methods in this study;at the same time,the alternative method has good performances on the specificity,linearity and robustness.Conclusion:This study provides practi-cal cases and references for the validation of alternative microbial testing methods.