注射用福沙匹坦二甲葡胺中细菌内毒素检查法的建立  

Determination of bacterial endotoxin of fosaprepitant dimeglumine for injection

作　　者：章亚兵 许雷鸣[1] 

机构地区：[1]安徽省食品药品检验所,安徽合肥230051

出　　处：《安徽医药》2013年第8期1298-1300,共3页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省食品药品监管系统科研项目(No 0004)

摘　　要：目的研究注射用福沙匹坦二甲葡胺细菌内毒素检查方法的建立。方法根据《中国药典》2010年版二部附录规定,确定试验溶液浓度和内毒素限度。结果在将样品稀释至3 g·L-1时无干扰,并将细菌内毒素限度为0.6 EU·mg-1。结论采用鲎试剂检查法对注射用福沙匹坦二甲葡胺中的内毒素检查是可行的。Objective To study the feasibility of bacterial endotoxin determination of fosaprepitant dimeglumine for injection.Methods According to bacterial endotoxin determination stated in appendixⅡ of Chinese Pharmacopiea（2010 edition）,the concentration of samples and bacterial endotoxin limit were determined.Results Samples were diluted to 3 g.L-1,which did not interfere with bacteria endotoxin test.The limitation of bacteria endotoxin was 0.6 EU.mg-1.Conclusion It is feasible to detect the bacterial endotoxin of fosaprepitant dimeglumine for injection with the method of TAL.

关 键 词：注射用福沙匹坦二甲葡胺 细菌内毒素 鲎试剂 干扰试验 

分 类 号：R927[医药卫生—药学]