rhGM-CSF/IL-3融合蛋白的细菌内毒素测定及其干扰因子的研究

Influence on the bacterial endotoxin test for rhGMCSF/IL3 fusion protein

目的：ｒｈＧＭＣＳＦ／ＩＬ３融合蛋白（简称Ｇ３）的细菌内毒素检查及干扰因子（如凝血酶，透析袋，Ｔｒｉｓ等）的研究。方法：分别作了两种鲎试剂（普通鲎试剂和特异性鲎试剂）的对比实验。结果：发现几种干扰因子对两种鲎试剂的影响程度不同，特异性鲎试剂受影响程度较小。结论：说明了Ｇ３样品的细菌内毒素检查使用特异性鲎试剂更合适，并建议适用于在生产过程中存在以上几种干扰因子的生物制品的内毒素检查。

OBJECTIVE: The bacterial endotoxin test for rhGMCSF/IL3 fusion protein was estabtished and some interfering factors were studied. METHOD: The comparison between two kinds of tachypleus amebocyte lysate(TAL)(the universal TAL and the specificity TAL) was carried out to identifythe interfering factors (thrombase,Tris and dialisis,etc) for the test.T5HZRESULT: It was found that the interference factor affected the realtionof the two kinds of TAL,especially the universal TAL. CONCLUSION: The result suggested that it is better to use the specificity TAL in the endotoxin test for rhGMCSF/IL3 fusion protein.