复方呋喃西林滴鼻液微生物限度检查的验证

Validation of Microbial Limit Test Method of Compound Furacilin Nasal Drops

目的:建立复方呋喃西林滴鼻液的微生物限度检查法。方法:根据《中国药典》2010年版二部附录"微生物限度检查法"分别采用常规法、薄膜过滤法进行复方呋喃西林滴鼻液的微生物限度检查验证。结果:采用常规法时,大肠埃希菌、金黄色葡萄球菌回收率均小于70%,其他菌回收率大于70%;细菌计数采用薄膜过滤法,并用500mL无菌氯化钠注射液冲洗滤膜,回收率大于70%;霉菌、酵母菌计数可用常规法,控制菌采用薄膜过滤法验证检出阳性菌,阴性菌未检出。结论:可采用常规法与薄膜过滤法相结合的方法进行复方呋喃西林滴鼻液的微生物限度检查。

OBJECTIVE： To establish a method for the microbial limit test of Compound furacilin nasal drops. METHODS： The microbial limit test of Compound furacilin nasal drops was validated by routine method and membrane filtration method in accordance with the appendix 11 of Chinese Pharmacopoeia （2010 edition）. RESULTS： The recoveries of Escherichia coli and Staphylococcus aureus by routine method were less than 70%, the recoveries of other bacterials were more than 70%. The bacterial was counted by membrane filtration method, and washed by 500 mL sterile Sodium chloride injection, the recoveries were more than 70% ; routine method could be adopted for mould and yeast count. The test organisms by membrane filtration method were detected in the control bacteria test and negative bacterial were not detected. CONCLUSION： The conventional method and the membrane filtration method combined can be applied for microbial limit test of Compound furacilin nasal drops.