甲硝唑诺氟沙星栓微生物限度检查方法研究(1)
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[摘要] 目的:建立甲硝唑诺氟沙星栓微生物限度检查方法。方法:以含1%吐温-80的pH=7.0无菌氯化钠-蛋白胨缓冲液为溶剂,用匀浆法制备供试品溶液,采用薄膜过滤并在培养基中加入中和剂的方法,来进行细菌数的检测和控制菌检查。霉菌及酵母菌数的测定,可采用培养基稀释法。结果:可以有效地去除甲硝唑诺氟沙星栓的抗菌成分,5种阳性菌的回收率均达到70%,符合《中国药典》2005年版的要求。结论:所建立的方法适用于甲硝唑诺氟沙星栓的微生物限度检查。
[关键词] 甲硝唑诺氟沙星栓;匀浆;薄膜过滤;中和剂
[中图分类号] R927.2[文献标识码]A [文章编号]1673-7210(2010)02(a)-042-03
Study on method of microbial limit test for Metronidazole-norfloxacin Suppositories
ZHOU Xiusen, LI Daoming
(Xinyang Institute for Food and Drug Control, Xinyang 464000, China)
[Abstract] Objective: To establish a method of microbial limit test for Metronidazole-norfloxacin Suppositories. Methods: 1% Tween-80 sterile sodium chloride-peptone buffer(pH=7.0) as the solvent, The solution for test were prepared by homogenate technique, Bacterial count and the controlled bacterium was examined by membrane filtration method and medium added neutralizer, The number of molds and yeast were determined with media dilution method ......
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