注射用脑蛋白水解物细菌内毒素检查法的建立  

Establishment of Bacterial Endotoxins Test Method for Cerebroprotein Hydrolysate Injection

作　　者：王宗春[1] 姜俊勇[1] 宋金春[1] 

机构地区：[1]武汉大学人民医院药学部,湖北武汉430060

出　　处：《食品与药品》2012年第1期45-47,共3页Food and Drug

基　　金：湖北省科技厅科技攻关项目(NO:2002AA301C13)

摘　　要：目的建立检查注射用脑蛋白水解物细菌内毒素的方法。方法按照中国药典2010年版(二部)附录XIE细菌内毒素检查法,对3批样品进行干扰试验和细菌内毒素检查。结果注射用脑蛋白水解物的游离氨基酸质量浓度0.5 mg/mL时,供试品不干扰细菌内毒素检查。结论建立的注射用脑蛋白水解物细菌内毒素检查法可行,细菌内毒素限值确定为0.5 EU/mg。Objective To establish a method for the detection of bacterial endotoxins in cerebroprotein hydrolysate injection.Methods Three batches of samples were used for interference test and bacterial endotoxins test in accordance with Appendix ⅪE,Volume 2,2010 Edition of Chinese Pharmacopoeia.Results The detection of bacterial endotoxins was not interfered by the sample when the concentration of free amino acids was below 0.5 mg/mL.Conclusion The test method of bacterial endotoxins is feasible for the cerebroprotein hydrolysate injection and the bacterial endotoxins limit is set at 0.5 EU/mg.

关 键 词：注射用脑蛋白水解物 细菌内毒素 鲎试剂 干扰实验 

分 类 号：R971[医药卫生—药品]