抗淋巴细胞免疫球蛋白制品中热原处理

Treatment of Pyrogen in Anti-Lymphocyte Immunoglobulin

对热原不合格的抗淋巴细胞免疫球蛋白 (ALG)半制品再制条件进行了研究。将高热原的ALG半制品通过使用碱、酸以及A5 0处理后 ,细菌内毒素的含量明显降低 ,热原质经家兔和鲎试剂检测均合格 ,其生物学效价仍不低于 1 :4 0 0 0 ,而且它们的其它各项主要指标也都达到中国生物制品暂行规程的要求。这一试验结果表明碱、酸处理并辅以A5

The reproductive conditions of anti-lymphocyte immunoglobulin(ALG) semi-finished product unqualified in pyrogen were studied. The content of bacterial endotoxin obviously decreased when the semi-finished products in high pyrogen were treated with HCl, NaOH and A50. The pyrogen of ALG semi-finished product reached the Requirement Standard by the Rabbit test and Limulus Amebocyte Lysate(LAL) test. Its biological activity still kept at a level of ≥1:4000 after treatment. The result showed that the treatment was an effective method to eliminate pyrogen of ALG.