应用鲎试剂检测吡拉西坦葡萄糖注射液中的细菌内毒素  

A TAL Method for Testing of Bacterial Endotoxin in Piraletam and Glucose Injection

作　　者：赵会兰 甘德珍 

机构地区：[1]云南丽江市药品检验所,674100

出　　处：《中国药事》2006年第9期552-553,共2页Chinese Pharmaceutical Affairs

摘　　要：建立吡拉西坦葡萄糖注射液的细菌内毒素检查法。参照《中国药典》2005年版二部附录“细菌内毒素检查法”进行干扰试验和结果判断。样品的最大无干扰浓度为16mg.ml-1,用浓度为6.4mg.ml-1的样品液进行细菌内毒素检查,结果无干扰作用。本品可以用细菌内毒素检查法代替家兔热原检查法。A TAL method for the testing of bacterial endotoxin in Piraletam and Glucose Injection was established. The ＂testing methods for bacterial endotoxin＂ listed in the appendix of 2005 version of China Pharmacopoeia （Ⅱ） was used as reference for interference test and result estimation. The maximum freeinterference sample concentration was 16mg · ml^-1. When the concentration of sample solution was 6.4mg · ml^-1, no interference effect occurred. The TAL method could be used to replace rabbit method for pyrogen monitoring.

关 键 词：吡拉西坦葡萄糖注射液 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]