关键词: font-size:medium, ">奥替拉西钾；微生物限度检查；方法适用性试验

Abstract: Objective： To study and establish a method for determining the microbial limit of raw material oteracil potassium. Methods： According to general rule 1105 and 1106 of Chinese Pharmacopoeia (2020 edition) Volume Ⅳ， plate method， adding dilution method， and membrane filtration method were used for microbial counting. Conventional method and increasing volume of culture medium were used for testing specified microorganisms. Results： In the applicability test of adding dilution method (1∶100) for aerobic bacterial count of samples and the applicability test of adding dilution method (1∶20) for mould and yeast count， the ratio of the experimental group to the bacterial control group was between 0.5 and 2. In the applicability test of the conventional method for controlling bacteria (Escherichia coli)， no positive bacteria were detected in the test group and the negative control group， while the positive control group detected positive bacteria. The above experimental results all comply with the provisions of the Chinese Pharmacopoeia. Conclusion： The established method can be applied in the microbial limit test of oteracil potassium， and can be used as reference for the detection of raw material oteracil potassium.

Key words: font-size:medium, ">Oteracil potassium； Microbial limit test； Applicability test