硫酸头孢匹罗及注射用硫酸头孢匹罗细菌内毒素检查法的研究  

The Study on the Determination Method of the Bacterial Endotoxins in Cefpirome Sulfate and Cefpirome Sulfate for Injection

作　　者：王丽萍[1] 马辉[1] 李庆忠[1] 

机构地区：[1]黑龙江省药品检验所,哈尔滨150001

出　　处：《中国药品标准》2008年第1期30-33,共4页Drug Standards of China

摘　　要：目的:建立硫酸头孢匹罗及注射用硫酸头孢匹罗细菌内毒素检查法。方法:按《中国药典》2005年版二部附录XIE进行实验和结果判断。结果:硫酸头孢匹罗最大不干扰浓度为5g·L-1;注射用硫酸头孢匹罗最大不干扰浓度为5g·L-1。结论:可建立硫酸头孢匹罗及注射用硫酸头孢匹罗的细菌内毒素检查方法。Objectives： To set up the bacterial endotoxins determination method for Cefpirome Sulfate and Cefpirome Sulfate for Injection. Methods： The experiment was carried on and the result was judged according to the appendix XI E of Chinese Pharmacopoeia 2005 Vol. Ⅱ. Results：Maximum nondisturb concentration of Cefpirome Sulfate for bacterial endotoxins test was 5 g · L^-1;Maximum nondisturb concentration of Cefpirome Sulfate for Injection for bacterial endotoxins test was 5 g · L^-1. Conclusions： The established method of endotoxins test is feasible for Cefpirome Sulfate and Cefpirome Sulfate for Injection.

关 键 词：硫酸头孢匹罗 注射用硫酸头孢匹罗 细菌内毒素 鲎试剂 干扰试验 

分 类 号：R927.12[医药卫生—药学] R978.11