摘要
目的:建立复方色甘酸钠鼻喷剂微生物限度检查方法。方法:按照2010年版《中国药典》附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查方法进行验证。采用薄膜过滤法对细菌、霉菌及酵母菌计数,采用薄膜过滤法对控制菌的检查方法进行方法学验证。结果:细菌、霉菌及酵母菌的回收率均大于70%。在控制菌的检查中,各阳性菌均检出,阴性对照无菌生长。结论:建立的复方色甘酸钠微生物限度检查方法可靠、准确、全面。该方法用于复方色甘酸钠鼻喷剂的微生物限度检查。
OBJECTIVE To establish the microbial limit tese of fufangsegansuanna nasal spyay. METHODS The validation on the microbial limit test method was conducted in accordance with the counting method of bacteria, mycetes and yeasts and the control bacteria test method stated in the appendix of Chinese pharmacopoeia （2010 edition）. Membrance filtration method was used in bacterium, mycetes and yeasts count; and Membranee filtration method was used in the control bacteria test. RESULTS The recovery rates of bacterias ,mycetes and yeasts were more than 70 %. The result of control bacteria checking showed that all positive test bacteria were detected, and no negative control bacteria occurred. CONCLUSION The established method can eliminate the antimimicrobial in fufangsegansuanna nasal spray, it is accurate, comprehensive, and it can be used for the microbial limit test of fufangsegansuanna nasal spray.
出处
《广东化工》
CAS
2016年第8期75-76,71,共3页
Guangdong Chemical Industry
