氧氟沙星凝胶微生物限度检查方法研究

摘要

OBJECTIVE:To establish a method of microbial limit test for Ofloxacin gel. METHODS:Test sample solutions were prepared by MnSO4,CaCl2 and MgCl2 gelout with different concentrations,the numbers of bacteria and control bacteria were detected by membrane filtration method,and the numbers of molds and yeasts were determined by conventional method. RE-SULTS:The conventional method showed the recoveries of Candida albicaus and Aspergillus niger were more than 70% after not treated by gel breaker;the membrane filtration method showed the recoveries of Escherichia coli,Staphylococcus aurus and Baci-lus subtilis were more than 70% after treated by 5% MnSO4,3% CaCl2 and 1% MgCl2;the membrane filtration method could de-tect the control bacteria after treated by gel breaker. CONCLUSIONS:Gel breaker with appropriate concentrations can effectively eliminate the antibacterial activity of Ofloxacin gel. The established method is suitable for its microbial limit test.%目的：建立氧氟沙星凝胶的微生物限度检查方法。方法：采用不同浓度的硫酸锰、氯化钙、氯化镁破胶制备供试液，采用薄膜过滤法检查细菌数和控制菌，同时采用常规法检查霉菌和酵母菌数。结果：不以破胶剂处理制备供试液，经常规法检查，白色念珠菌和黑曲霉的回收率均＞70％；以5％硫酸锰、3％氯化钙、1％氯化镁处理制备的供试液，经薄膜过滤法检查，大肠埃希菌、金黄色葡萄球菌和枯草芽孢杆菌的回收率均＞70％；以破胶剂处理制备的供试液，经薄膜过滤法检查，能正常检出控制菌。结论：加入适当浓度的破胶剂能够有效消除氧氟沙星凝胶的抑菌性。所建立的方法适用于该制剂的微生物限度检查。