柴胡注射液细菌内毒素检查法的探讨  

Establishment of Bacterial Endotoxin Test of Chaihu Injection

作　　者：李姮[1] 

机构地区：[1]江苏省连云港市药品检验所,连云港222006

出　　处：《中国药事》2017年第2期174-177,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:建立柴胡注射液细菌内毒素检查法。方法:依据《中国药典》2010年版附录中细菌内毒素检查法,通过预干扰和干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果:将柴胡注射液稀释200倍,对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查柴胡注射液的细菌内毒素可行。Objective： To establish a method for bacterial endotoxin test of Chaihu injection. Method： Maximal non-interference concentrations of samples were determined by pre-interference test according to the appendix of Chinese Pharmacopiea（2010 edition）. And then methodology validation was conducted. Results： The interference on bacterial endotoxin test could be excluded when the sample was diluted 200 times. Conclusion：The established method is feasible to detect the bacterial endotoxin of Chaihu injection.

关 键 词：柴胡注射液 细菌内毒素检查 凝胶法 干扰试验 

分 类 号：R927[医药卫生—药学]