复方乳酸钠葡萄糖注射液细菌内毒素检测法实验研究  

Determination of the Bacterial Endotoxins in Compound Sodium Lactate and Glucose Injection

作　　者：孟群[1] 汪岱迪[1] 居红枫[1] 

机构地区：[1]江苏省药品检验所,南京210008

出　　处：《中国药品标准》2004年第5期26-28,共3页Drug Standards of China

摘　　要：目的:建立复方乳酸钠葡萄糖注射液的细菌内毒素检查方法。方法:用两个生产厂的鲎试剂对复方乳酸钠葡萄糖注射液进行干扰试验研究。结果:复方乳酸钠葡萄糖注射液对细菌内毒素检查有干扰作用,但通过稀释可消除其干扰。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。Objective:To establish the method for determination of the bacterial endotoxin in Compound Sodium Lactate and Glucose Injection. Methods:Inhibition and Enhancement test was performed with Amebocyte Lysate manufactured by two different companies. Results:The injection will interfere to the Bacterial Endotoxins test,but the inhibition effect can be eliminated by appropriate dilution. Conclusions:The results suggest that Bacterial Endotoxin test (gel-clot method) can be used as an alternative method for the rabbit pyrogen test for Compound Sodium Lactate and Glucose Injection.

关 键 词：复方乳酸钠 葡萄糖注射液 细菌内毒素检测法 细菌内毒素检查 实验研究 干扰试验 热原检查法 代替 凝胶法 稀释 

分 类 号：R927[医药卫生—药学] R614