鱼腥草注射液细菌内毒素检测  

The Determination of the endotoxin in yuxingcao injection

作　　者：宋英兰 张斌 

机构地区：[1]陕西省宝鸡市药品检验所,宝鸡721001

出　　处：《中国药品标准》2004年第1期58-60,共3页Drug Standards of China

摘　　要：目的:建立鱼腥草注射液细菌内毒素的检查方法。方法:按中国药典2000版二部附录XIE·XIXF进行实验和结果判断。结果:血腥草注射液最大非干扰浓度为20倍稀释液(100mg/ml)。对5批样品进行细菌内毒素检查,其内毒素含量均小于理论限值1.43EU·ml^(-1)。结论:可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制其热原。To establish the endotoxin determination method for monitoring pyrogen of Yuxingcao Injection. Methods : The experiment was made and the result was judged according to the appendix XIE, XIXF of Chinese pharmacopeia (2000) vol Ⅱ. Results: Maximum Nondisturb concentration of Yuxingcao Injection for bacterial endotoxin test was twenty times diluting(100mg/ml). The endotoxin content was even less than the limit (1. 43EU·ml-1)in each of five lots Yuxingcao Injection. Conclusions :Amebocyte Lysate method can be used in place of rabbit method for pyrogen monitoring of Yuxingcao Injection.

关 键 词：鱼腥草注射液 细菌内毒素 热原检查 凝胶法 干扰试验 

分 类 号：R927.12[医药卫生—药学]