3种含醋酸氯己定制剂的微生物限度检查方法研究

摘 要 目的：建立3种含醋酸氯己定制剂的微生物限度检查方法。方法: 采用常规法、稀释法、薄膜过滤法、中和法对醋酸氯己定溶液、醋酸氯己定软膏、醋酸氯己定乳膏3种含醋酸氯己定制剂进行微生物限度检查方法验证。结果: 采用薄膜过滤法和中和法在计数法验证中的5种菌株的回收率均达到50%以上；控制菌检查中各阳性试验菌均检出，阴性对照菌均无菌生长。结论: 醋酸氯己定溶液和醋酸氯己定软膏控制菌检查可用薄膜过滤法，醋酸氯己定乳膏控制菌检查可用中和法进行。

Study on Microbial Limit Test Methods for Three Preparations Containing Chlorhexidine Acetate

ABSTRACT Objective: To establish the microbial limit test methods for three preparations containing chlorhexidine acetate. Methods: The validation of microbiological limit test for three preparations including chlorhexidine acetate solution, chlorhexidine acetate ointment and chlorhexidine acetate cream was carried out respectively using the conventional method, dilution method, membrane filtration method and neutralization method. Results: The recovery rates of five strains in the verification of counting method by membirane filtration and nearailzation method were more than 50%. Every positive test micrcorganism could be detected while negative control bacteria could not grow in the examination of control bacteria.Conclusion:The membrane filtration method can be used for the determination of control bacteria for chlorhexidine acetate solution and chlorhexidine acetate ointment, and the neutralization method can be applied in the determination of control bacteria for chlorhexidine acetate cream.