复方维生素注射液(4)细菌内毒素检查法的建立

Establish of the Bacterial Endotoxins Test of Compound Vitamin(4) Injection

目的:建立复方维生素注射液(4)细菌内毒素检查的方法。方法:用两个生产厂家的鲎试剂对两个厂家6个批号的复方维生素注射液(4)分别进行干扰实验,考察确立该品种细菌内毒素的检测方法。结果:复方维生素注射液(4)对细菌内毒素检查有干扰作用,但稀释100倍以上可消除。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。其细菌内毒素限值为50EU/ml。

Objective：To establish the Bacterial Endotoxins Test of Compound Vitamin （4） Injection. Methods：The interference test of 6 batches of samples with 2 limulus test agents was carried out. Results：There was interference effect of Compound Vitamin （4） Injection on the reaction of bacterial endotoxin and tachypleus amebocyte lysate. But the interference can be neutralized by diluting the solution concentration to 1∶100. Conclusion：These results suggest that the Bacterial Endotoxins Test can be used for the detection of endotoxin in Compound Vitamin （4） Injection instead of pyrogen test,and its endotoxin limit concentration can be established as less than 50 EU/ml.