吡咯类抗真菌药物制剂微生物限度检查方法的研究

Validation of microbiological test for the antifungal drug of piromidic

目的:研究建立吡咯类抗真菌药物制剂的微生物限度检查方法。方法:通过预试验摸索,拟以含有组氨酸、卵磷脂和聚山梨酯80的混合溶液作为稀释剂及冲洗液,采用离心沉淀集菌法与薄膜过滤法联用的方法进行此类药物的微生物限度检查并进行方法学验证。结果:按《中国药典》2005年版附录要求对拟定方法进行验证,结果验证菌株的回收率均大于70%,控制菌检查阳性菌也生长良好。结论:以含有组氨酸、卵磷脂和聚山梨酯80的混合溶液作为稀释剂及冲洗液,采用离心沉淀集菌法与薄膜过滤法联用进行吡咯类抗真菌药物制剂的微生物限度检查,方法是可行的。

Objective：To establish a method of microbial limit test on the antifungal drug of piromidic. Methods：According to the result of test beforehand, we used the histidine,lecithin,Tween 80 mixed solution as the diluent and lotion. The methods of contrifugal precipitation and membrance filtration were used for collecting bacteria and validation of microbiological test. Results： The ratio of recoveries of five germs were bigger than 70%, and the requirement of the Pharmacoeia of China （ChP） 2005 were reached. Conclusion： The method is suitable to the microbial limit test for the antifungal drug of piromidic.