氟罗沙星注射液无菌检查方法的探讨

Method of sterility test for fleroxacin injection

目的探讨氟罗沙星注射液的无菌检查方法。方法按中国药典2010年版二部附录ⅪH无菌检查法的要求进行方法验证试验。采用薄膜过滤法,将样品稀释后过滤冲洗或将样品直接冲洗后,在培养基中加入适当的中和剂,分别进行试验。结果采用以上两种方法试验,敏感菌均可正常生长。结论采用增加中和剂或过滤前稀释处理进行无菌检查,方法可行。

Aim To discuss the method for sterility of fleroxacin injection.Methods Sterility tests were validated according to the method from appendix of volume two,Chinese Phamacopoeia Edition 2010.The filtration method was adopted,Two validation tests were engaged,one is to dilute the sample before filtration and rinsing,the other is to add reasonable neutralizer to medium after filtration and rinsing.Results The two methods both show that sensitive strain all reveal normal growth.Conclusion The two validated methods to add neutralizer or dilute the sample before filtration and rinsing can be used to test for sterility of this sample.