胞必佳的细菌内毒素检查

The Bacterial Endotoxins Test of Baobijia

目的 考察胞必佳的细菌内毒素检查法的可行性并进行检查。 方法 采用中国生物制品规程 2 0 0 0年版细菌内毒素检查法。 结果 胞必佳可用灵敏度 0 .5 EU· m L- 1的鲎试剂作细菌内毒素检查。 结论 4个批号的胞必佳经检查均符合要求。

OBJECTIVE To inspect on the feasibility of bacterial endotoxins test(BET)for Baobijia and to test.METHODS BET of Chinese Requirements for Biologics version 2000.RESULTS Baobijia could be tested by tachypleus amebocyte lysate(TAL)with the sentivity of 0.25EU·mL -1 .CONCLUSION Four batches of Baobijia met the requirements by test.