乙酰谷酰胺葡萄糖注射液的细菌内毒素量的测定

Determination of Bacterial endotoxin quantity in Acetyl Glutamine Glucose Injection

目的建立乙酰谷酰胺葡萄糖注射液的细菌内毒素的检查方法。方法依据细菌内毒素检查法(中国药典2005年版附录XI、E),对乙酰谷酰胺葡萄糖注射液的细菌内毒素进行试验。结果用标示灵敏度为0.25Eu.ml-1的鲎试剂检测三批乙酰谷酰胺葡萄糖注射液的细菌内毒素量均小于0.5EU.ml-1。结论用细菌内毒素法检查乙酰谷酰胺葡萄糖注射液的热原,无干扰,灵敏度符合规定,方法可行。

To establish bacterial endotoxin determination method for Acetyl glutamine Glucose Injection.METHODS The experiment and the judgement of its result were made according to the appendix XI and E of Chinese pharmacopoeia 2005 Vol Ⅱ. RESULTS The endotoxin content of injection detected with 0. 25 EU · ml^-1 sensitivity of LAL was less than 0. 5 EU·ml^-1. CONCLUSION The test is valid for estimating the bacterial endotoxin that in the sample of Acetyl glutamine Glucose Injection without inhibition and enhancement.