注射用夫西地酸钠细菌内毒素检查方法研究  

Study on Bacterial Endotoxin Test of Sodium Fusidate for Injection

作　　者：徐冬[1] 徐玲笑 

机构地区：[1]浙江衢化医院,浙江衢州324004 [2]衢州市食品药品检验所,浙江衢州324002

出　　处：《中国药房》2012年第9期844-845,共2页China Pharmacy

摘　　要：目的:建立注射用夫西地酸钠的细菌内毒素检查方法。方法:参照《中国药典》2010年版附录中的凝胶法,通过干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果:样品稀释至浓度0.50mg·mL-1时对细菌内毒素检查法无干扰作用。结论:所建方法可用于检查注射用夫西地酸钠中的细菌内毒素。OBJECTIVE：To establish a method for bacterial endotoxin test of Sodium fusidate for injection.METHODS：Maximum concentration without interference of samples was determined by interference test according to gel-clot stated in appendix of Chinese Pharmacopoeia（2010 edition）.And then methodology validation was conducted.RESULTS：The interference on bacterial endotoxin test can be excluded when sample was diluted to below 0.50 mg·mL-1.CONCLUSION：The established method is feasible to detect the bacterial endotoxin of Sodium fusidate for injection.

关 键 词：注射用夫西地酸钠 细菌内毒素检查 凝胶法 干扰试验 

分 类 号：R927.12[医药卫生—药学] R978