注射用葡萄糖酸依诺沙星细菌内毒素检查法的建立  

Bacterial Endotoxins Test for Enoxacin Gluconate for Injection

作　　者：韩佩莲 

机构地区：[1]大同市惠达药业有限责任公司,大同037006

出　　处：《中国药品标准》2008年第1期25-27,共3页Drug Standards of China

摘　　要：目的:确立注射用葡萄糖酸依诺沙星细菌内毒素检查方法。方法:参照《中华人民共和国药典》2005年版二部附录XIE细菌内毒素检查方法要求进行试验。结果:每1mg葡萄酸依诺沙星内毒素不得过0.5EU。结论:该药采用细菌内毒素检查法代替热原检查法,方法可行。Objective：To establish a method of test for bacterial endotoxins of Enoxacin Gluconate for Injection. Methods：Experiment was conducted according to bacterial endotoxins test in Chinese Pharmacopeia 2005, Volume Ⅱ. Result：The quality of bacteria in Enoxacin Gluconate for Injection must less than 0. 5 EU per mg. Conclusion：It is feasible for bacterial endotoxins test instead of pyrogen test.

关 键 词：注射用葡萄糖酸依诺沙星 细菌内毒素检查法 热原检查法 药物治疗 

分 类 号：R927.12[医药卫生—药学] R978.1