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吡咯类抗真菌药物制剂微生物限度检查方法的研究
引用本文:刘文杰,江志杰,余立,高春,王似锦. 吡咯类抗真菌药物制剂微生物限度检查方法的研究[J]. 中国医药导报, 2008, 5(29): 28-30
作者姓名:刘文杰  江志杰  余立  高春  王似锦
作者单位:北京市药品检验所,北京,100035
摘    要: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。

关 键 词:吡咯类抗真菌药物制剂  微生物限度检查  离心集菌法  薄膜过滤法

Validation of microbiological test for the antifungal drug of piromidic
LIU We-njie,JIAG Zhi-jie,YU Li,GAO Chun,WANG Si-jin. Validation of microbiological test for the antifungal drug of piromidic[J]. China Medical Herald, 2008, 5(29): 28-30
Authors:LIU We-njie  JIAG Zhi-jie  YU Li  GAO Chun  WANG Si-jin
Affiliation:(Beijing Institute for Drug Control, Beijing 100035,China)
Abstract: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.
Keywords:Antifungal drug of piromidic  Validation of microbiological test  Centrifugal precipitation  Membrane filtration methods
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