注射用唑来膦酸细菌内毒素检查法的可行性研究  

The Research on the Feasibility for the Bacterial Endotoxins Test of Zoledronic Acid for Injection

作　　者：武少馨[1] 王凤茹[1] 韩文华[1] 

机构地区：[1]河北省药品检验所,石家庄050011

出　　处：《中国药品标准》2006年第5期35-37,共3页Drug Standards of China

摘　　要：目的:建立注射用唑来膦酸的细菌内毒素检查方法。方法:按中国药典2000年版二部附录E、F进行实验和结果判断。结果:注射用唑来膦酸细菌内毒素量均小于12.5EU/mg。结论:本品细菌内毒素检查定为:取本品,按中国药典2000年版细菌内毒素检查法附录E检查,每1mg含细菌内毒素的量应小于12.5EU。可以用细菌内毒素法代替家兔法作为日常检测注射用唑来膦酸的热原检查。Objective：To establish the endotoxin determination method for monitoring pyrogen of Zoledronic Acid for Injection. Method ： Tbe experiment was made and the result was judged according to the appendix ⅪE、ⅪF of Chinese Pharmacopoeia （2000） vol. Ⅱ. Results ：The endotoxin content was less than the limit （12.5EU/mg）in each three lots of Zoledronic Acid for Injection. Conclusion ：Bacterial endotoxins ：It contains not more than 12.5EU per mg of Zoledronic Acid for Injection. Bacterial endotoxin test can be used in place of rabbit method for routine pyrogen monitoring of Zoledronic Acid for Injection.

关 键 词：注射用唑来膦酸 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]