肝素钠乳膏剂的微生物方法验证及限度检查

目的:检查肝素钠乳膏剂中含有微生物的总数及控制菌.方法:采用中国药典2005年版第二部附录Ⅺ微生物限度检查方法对肝素钠乳膏剂中细菌、霉菌、酵母菌总数进行限度检查,同时对肝素钠乳膏剂中控制菌金黄色葡萄球菌和铜绿假单胞菌生长进行检查,并对测定方法进行验证性实验.结果:肝素钠乳膏剂中细菌、霉菌、酵母菌总数均小于每毫升10个,同时未见到金黄色葡萄球菌和铜绿假单胞菌生长.结论:肝素钠乳膏剂供试品微生物限度检查方法正确,供试品检查合格.

Validation Test and Microbial Limit Determination for Heparin Sodium Emulsification Ointment

Objective:To estimate the total number of viable microorganisms and check for the control bacteria pres- ent in the Heparin sodium emulsification ointment.Methods:the growth of bacteria,molds and yeast is tested according to the method of microbial limit tests in Pharmacopoeia of People's Republic of China,Edition 2005,appendix XI,the adopted method is also validated.Results:the number of colonies is less than 10 CFU/ml for bacteria,molds and yeast respectively;Staphylococcus aureus and Pseudomonas aeruginose aren't detected.the adopted method meets the requirement of microbial standard in the pharmacopoeia,the number of bacteria colonies,number of fungal(yeast) colonies and con- trol bacteria conform the microbial described under specified monograph.Conclusion:Heparin sodium emulsification olntment passes the requirement.