动态比浊法检测注射用右旋雷贝拉唑钠细菌内毒素方法的建立  

Study on Dynamic Turbidimetry of Bacterial Endotoxin Test for Dexrabeprazole Sodium for Injection

作　　者：李展[1] 周继春[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药品标准》2015年第3期181-183,共3页Drug Standards of China

摘　　要：目的:建立注射用右旋雷贝拉唑钠细菌内毒素动态浊度法检测方法。方法:按照《中国药典》2010年版二部相关附录,用动态浊度法进行干扰试验。结果:0.06 mg·mL^(-1)右旋雷贝拉唑钠无干扰作用,内毒素回收率均在50%~200%之间。结论:本品可用动态浊度法进行细菌内毒素定量检测,建议其内毒素限值为每1 mg右旋雷贝拉唑钠中含内毒素的量应小于10.0 EU。Objective：To establish a method of dynamic turbidimetry of bacterial endotoxin test for Dexrabeprazole Sodium for Injec-tion.Methods：According to the relevant appendix of Chinese Pharmacopoeia 2010 second section, dynamic turbidimetry was used for the interference test of Dexrabeprazole Sodium for Injection.Results：0.06 mg· mL^-1 Dexrabeprazole Sodium had no interference and the recovery rate of bacterial endotoxin was within 50%-200%.Conclusion：Dynamic turbidimetry can be used for bacterial endotox-in test of Dexrabeprazole Sodium and the limit should be set at less than 10.0 EU· mg^-1.

关 键 词：右旋雷贝拉唑钠 细菌内毒素 动态浊度法 

分 类 号：R921.2[医药卫生—药学]