小儿呋麻滴鼻液微生物限度检查方法适用性研究

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。

Applicability Study on Microbial Limit Test for Ephedrine and Furacillin Nasal Drops for Infants

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.