盐酸环丙沙星乳膏微生物限度检查方法的研究

目的：建立盐酸环丙沙星乳膏微生物限度检查方法。方法：通过对培养基稀释法、中和法及薄膜过滤法等方法的试验研究；采用薄膜过滤法，用0．1％蛋白胨水溶液作冲洗剂，进行细菌计数及控制菌检查。霉菌、酵母菌计数采用培养基稀释法。结果：在3次独立平行试验中，试验组菌数和稀释剂对照组菌数的回收率均不低于70％。控制菌的试验组、阳性菌对照组均检出相应的控制菌，阴性菌对照组未检出。结论：经方法学验证试验，该方法可用于盐酸环丙沙星乳膏微生物限度检查。

Study of nicrobial limit test for ciprofloxacin hydrochloride cream

Objective： To establish a method for the nicrobial limit test of ciprofloxacin hydrochloride cream. Methods： The Methods of culture medium -diluting, acid -base titration and membrane filtration irrigation were adopted for the comparative study. The last one was confirmed as the optimal method. 0.1% Peptone solution was used as cleaning agent in bacteria counting and the control bacteria counting. The mould and saccharomycetes counting were performed by medium dilution method. Results： The bacterial count recoveries of testament group and control group were all over 70% in the 3 times independent parallel test. The control bacteria were detected in testament group of control - bacteria and positive bacteria, while negative group was not detected. Conclusion： The method can be used for the microbial limits testing of ciprofloxacin hydrochloride cream.