荧光染色计数法在制药用水微生物限度检查替代应用初探

A Tentative Exploration on Fluorescence Staining Counting Method as the Alternative Method of Microbial Limit Test for the Pharmaceutical Water

目的:考察荧光染色法在测定制药用水中微生物的方法适用性,评价荧光染色法在制药用水进行微生物限度检查的可行性。方法:按药品微生物检验替代方法验证指导原则的要求,从准确度、精密度、线性、定量限、范围等方面来进行定量检验的替代方法验证,并取实验室不同取样点纯化水样进行测试比较。结果:荧光染色法的各项验证参数均与药典方法相当,且不同取样点纯化水样的两种方法检测结果无显著差异。结论:本文的试验为荧光染色计数法后续在制药用水微生物检测中实际应用提供了参考。

Objective： To investigate the suitability of fluorescence staining counting method for microbial limit test in the pharmaceutical water and evaluate the feasibility of this method use. Methods： The proposed alternative method was validated base on the guidelines for validation of the alternative method for microbial limit test in pharmaceutical water. The validation included the accuracy, precision, limit of quantification, linearity, range, etc. The purified water samples from the multi-sampling points in the lab were tested and compared. Results： The validation parameters of the fluorescence staining counting method were equivalent to that of Chinese Pharmacopeia Methods. There were no significant differences between the two methods obtained test results of the purified water samples from the multi-sampling points. Conclusion： This exploration provides a reference for the fluorescence staining counting method being applied to the microbial limit test for the pharmaceutical water.