非布司他原料药微生物限度检查法的建立

Establishment of microbial limit test for pharmaceutical ingredients of febuxostat

目的 建立非布司他原料药的微生物限度检查法。方法 根据《中华人民共和国药典》2020年版的规定,对非布司他原料药微生物限度方法适用性进行研究。结果 需氧菌总数检查采用薄膜过滤法(1∶10供试液1 ml,含3%吐温80的pH 7.0无菌氯化钠-蛋白胨缓冲液冲洗300 ml/膜),方法适用性验证过程中试验菌需在最后一次冲洗液中加入。霉菌和酵母菌总数检查采用均质袋结合平皿法不可行,可采用薄膜过滤法(1∶10供试液1 ml,pH 7.0无菌氯化钠-蛋白胨缓冲液冲洗300 ml/膜),方法适用性验证过程中试验菌在供试液环节加入即可。大肠埃希菌的检查采用1∶10供试液10 ml依常规法检查。结论 本研究所建立的方法稳定、准确,可作为非布司他原料药微生物限度的检查方法。

Objective To establish a microbial limit test for pharmaceutical ingredients(API)of febuxostat.Methods According to the Pharmacopoeia of the People’s Republic of China(2020),the suitability of the microbial limit test for febuxostat API was studied.Results The membrane filtration method(1∶10 test solution 1 ml,pH 7.0 sterile sodium chloride-peptone buffer containing 3%Tween 80 was used to wash at 300 ml/membrane)was used to test the total number of aerobic bacteria.The test bacteria shall be added to the last washing solution during the method suitability validation process.It was not feasible to use a homogeneous bag combined with the plate method for testing the total number of molds and yeast.Instead,a membrane filtration method(1∶10 test solution 1 ml,pH 7.0 sterile sodium chloride-peptone buffer was used to wash at 300 ml/membrane)was used.During the method suitability validation process,the test bacteria could be added to the test solution.The test of Escherichia coli was carried out using a conventional method using 10 ml of 1∶10 test solution.Conclusion The method established in this study is stable and accurate,and can be used as a microbial limit test method for febuxostat API.