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小儿呋麻滴鼻液微生物限度检查方法适用性研究
田怀平,林志燕,王冉冉,王玲,杜毅
0
(上海交通大学医学院附属新华医院,上海 200092)
摘要:
目的:建立小儿呋麻滴鼻液的微生物限度检查方法。方法:参照《中国药典》2015年版的方法,制备1:10供试液,薄膜过滤法进行样品前处理,分别进行微生物计数检查和控制菌检查的方法适用性实验。结果:薄膜过滤法可有效消除小儿呋麻滴鼻液供试品的抗菌活性。微生物计数检查的5种实验菌的回收比值均在0.5 ~2.0之间。控制菌检查中铜绿假单胞菌、金黄色葡萄球菌和大肠埃希菌都能够检出。结论:采用1:10稀释法和薄膜过滤法的检查方法和检验条件,方法适用性实验已确认可以进行小儿呋麻滴鼻液的微生物限度检查。
关键词:  小儿呋麻滴鼻液  微生物限度检查  微生物计数检查  控制菌检查  薄膜过滤法
DOI:doi:10.13407/j.cnki.jpp.1672-108X.2018.11.015
基金项目:
Applicability Study on Microbial Limit Test for Ephedrine and Furacillin Nasal Drops for Infants
Tian Huaiping, Lin Zhiyan, Wang Ranran, Wang Ling, Du Yi
(Xinhua Hospital Affiliated to Shanghai Jiaotong University, School of Medicine, Shanghai 200092, China)
Abstract:
Objective: To establish a method for microbial limit test on ephedrine and furacillin nasal drops for infants. Methods: By reference to Chinese Pharmacopoeia (2015 Edition), the 1:10 test solution was prepared, and the sample pretreatment was carried outb under membrane-filter procedure, the applicability experiments of microbial count test and control bacteria test were conducted respectively. Results: The membrane-filter procedure could effectively eliminate the antibacterial active of ephedrine and furacillin nasal drops. The recovery ratios of the five experimental bacteria examined by microbial count were within 0.5~2.0. And seudomonas aeruginosa, staphylococcus aureus and escherichia coli can be detected in control bacteria. Conclusion: With the inspection method and test conditions of 1:10 dilution method and membrane-filter procedure, the applicability experiments has confirmed that microbial limit test of ephedrine and furacillin nasal drops for infants can be performed.
Key words:  ephedrine and furacillin nasal drops for infants  microbial limit test  microbial count test  controlled bacteria test  membrane-filter procedure

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