静脉注射用人免疫球蛋白细菌内毒素检测

Detection of bacterial endotoxin for immunoglobulin of human intravenous injection (IVIG)

探索静脉注射用人免疫球蛋白(IVIG)细菌内毒素含量的鲎试验检测方法。根据《中国药典》(2000版)细菌内毒素含量的检测方法进行,将待检品用NaOH调pH至中性,稀释至2.4倍可用标示灵敏度为0.25EU/m l的特异性鲎试剂进行细菌内毒素检测,结果与家兔法进行比较,并且在样品中加入定量内毒素0.6 EU/m l用两种方法进行对比试验。结果表明用细菌内毒素检测法(鲎试验法)检测静脉注射用人免疫球蛋白是可行的。

To explore the limulus test in detection of the content of bacterial endotoxin in IVIG. The investigation was conducted according to the method of testing endotoxin in China Pharmacopoeia （ year 2000 edition ）. Samples were diluted to 2.4 times after their pH were adjusted to neutral by NaOH solution. Then they were assayed for endotoxin by tachypleus amebocyte lysate labeled a sensitivity of 0.25EU/ml. The results were compared with those of pyrogen test in rabbits. The samples with a given concentration of bacterial endotoxin （0.6EU/ml ） were also tested by the two methods. The results showed that it is feasible to use limulus test to detect the content of bacterial endotoxin in IVIG.