氧氟沙星胶囊微生物限度检查方法的建立

Establishment of Microbial Limit Test for Ofloxacin Capsules

目的建立氧氟沙星胶囊的微生物限度检查方法。方法在供试液中添加氯化镁和聚山梨酯80,冲洗液中添加聚山梨酯80,采用薄膜过滤法对氧氟沙星胶囊需氧菌总数、霉菌和酵母菌总数的计数方法及控制菌大肠埃希菌的检查方法进行适用性试验。结果采用上述方法可有效消除氧氟沙星胶囊的抑菌作用,需氧菌、霉菌和酵母菌的总数计数方法适用性试验中的回收比值均在0.5~2.0之间;控制菌检查方法适用性试验检出阳性试验菌。结论所建立的方法可作为氧氟沙星胶囊的微生物限度检查方法。

Objective To establish a microbial limit test method for Ofloxacin Capsules.Methods By adding magnesium chloride and polysorbade 80 to the test solution and adding polysorbade 80 to the flushing solution,the suitability tests of the counting method of total aerobic bacteria,total mold and yeast in Ofloxacin Capsules and the checking method of controlling bacterial Escherichia coli were carried out by membrane filtration method.Results The above method can effectively eliminate the bacteriostasis of Ofloxacin Capsules.The recovery ratios of aerobic bacteria,mold and yeast in the suitability test of the counting methods were in the range of 0.5-2.0.Positive test bacteria were detected in the suitability test of control bacteria test method.Conclusion The established method can be used for the microbial limit test of Ofloxacin Capsules.