奥硝唑氯己定洗剂微生物限度检查的方法学验证

目的:建立奥硝唑氯己定洗剂微生物限度检查方法。方法:根据2005年版《中国药典》(二部)附录微生物限度检查法,对奥硝唑氯己定洗剂的微生物限度检查进行方法学验证,比较人工污染细菌的回收率来确定适宜的细菌、霉菌检验方法,并设立试验组和阴性菌对照组进行铜绿假单胞菌与金黄色葡萄球菌控制菌验证试验。结果:采用薄膜过滤法、冲洗液用量为300mL,微生物菌落回收率均高于70%,验证试验表明试验组见菌生长,而阴性菌对照组未见菌生长。结论:薄膜过滤法能有效去除奥硝唑氯己定洗剂中的抑菌成分,适用于该制剂的微生物限度检查和控制菌检查。

Method Validation for Microbial Limit Test of Ornidazole Chlorhexidine Lotions

OBJECTIVE：To establish a method for microbial limit test of Ornidazole chlorhexidine lotions.METHODS：Based on the method stated in Chinese Pharmacopoeia（2005 edition）,the microbial limit test of Ornidazole chlorhexidine lotions was validated.The optimal method for microbial limit test was confirmed by comparing the recovery rate of artificially sprayed bacteria.Validation tests of Pseudomonas aeruginosa and Staphylococcus aureus were carried out by setting trial group and negative bacterial control group.RESULTS：The membrane filtration method was adopted and amount of lotion was 300 mL.Recovery rate of microbial colony was higher than 70%.The growth of bacterium was found in trial group while not found in negative bacterial group.CONCLUSIONS：The membrane filtration method can get rid of the sterilization component of Ornidazole chlorhexidine lotions effectively.It is a more feasible method of microbial limit test and control bacteria test for Ornidazole chlorhexidine lotions.