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

摘要

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.%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。