硝酸咪康唑栓微生物限度检查方法探讨.pdfVIP

硝酸咪康唑栓微生物限度检查方法的探讨 1 2 3 张丹 ，卫延明,崔小莉 （1.陕西省食品药品检验所，陕西 西安 710061 ；2.陕西省渭南市药品检验所， 陕西 渭南 714000;3. 西安白云制药有限公司, 陕西 城固 723200) 摘要： 目的 探讨硝酸咪康唑栓微生物限度的检查方法。方法 以吐温 80 10﹪的 PH7.0 氯化钠-蛋白胨缓冲液为稀释液，在样品溶解后加入十四烷酸异丙酯 20ml,以 0.1﹪吐温 80 的 0.1﹪蛋白胨水溶液为冲洗液，细菌、霉菌酵母菌、金黄色葡萄球菌、白色念珠菌采用薄 膜过滤法，铜绿假单胞菌采用培养基稀释法。结果 采用薄膜过滤法，五种菌株的回收率均 高于 70%；采用培养基稀释法，结果检出铜绿假单胞菌。结论 经过试验比对，加入吐温 80 和十四烷酸异丙酯增强了样品的破乳作用，抑菌作用也得到了消除，同时提高了样品的分层 速度，使整个试验得以顺利进行。 关键词：硝酸咪康唑栓；破乳；十四烷酸异丙酯；薄膜过滤法 The Discussion of Microbial Limit Test Method for Miconazole Nitrate Suppositories 1 2 ZhANG Dan ， WEI Yan-ming ， CUI Xiaoli(1.Shaanxi Province Institute for Food ang Drug Control ，shaanxi Xi’an 716001China;2.Weinan Province Institute for Drug Control ， shaanxi weinan 714000China;3.A limited company that gets to make drug in Xi’an BaiYun,Shaanxi Chenggu 723200China) ABSTRACT ：OBJECTIVE To discuss the microbial limit test method of miconazole nitrate suppositories. METHODS In PH7.0 Sodium Choride Peptone buffer of 80 Twain 10% as diluent,20ml fourteen PHAs isoproterenol on lipid is added in the dilution liquid after the sample dissolved.Bacterial,fungal,Staphylococcus aureus and Candia albicans all use the membrane filtration method in 0.1% peptone water solution of 0.1% 80 Twain as flushing fluid,and Pseudomonas aeruginosa uses the medium dilution method. RESULTS With membrane filtration method,the recovery rate of the five strains were higher than 70%;Using the medium dilution method,Pseudomonas aeruginosa was found. CONCLUSION Joind 80 Twain and fourteen PHAs isoproterenol on lipid after experimental comparison,it may enhance demulsification function of the sample,but antibacterial activity has been eliminated.while improving stratified rate of the sample,the whole trial run smoothly. KEY WORDS ：miconazole nitrate suppo