【摘要】 对抗人淋巴细胞免疫球蛋白进行病毒灭活后的质量进行研究。抗人淋巴细胞免疫球蛋白通过低 p H孵化 2 4 d后 ( p H4 .1± 0 .3 ) ,其花环抑制免疫效价仍不小于 1:4 0 0 0 ;与灭活前相比 ,灭活后制品的纯度及 Ig G各组分含量没有显著差异 ( P>0 .0 5 ) ,并且其它各项指标均符合中国生物制品规程暂行规程的要求 ,从而表明抗人淋巴细胞免疫球蛋白通过酸孵育进行病毒灭活后的稳定性良好。更多还原

【Abstract】 The influence of virus inactivation by low-pH incubation on quality of anti-human lymphocyte immunoglobulin (ALG) was studied. The biological activity of ALG still kept at a level of ≥1∶4000 after viral inactivation by incubating for 24 days with the low-pH condition of 4.1±0.3. The purity and various IgG components of products had no significant difference before and after viral inactivation (P>0.05). All other indexes also met the Requirements of Biological Products. The results indicated that ALG was stable after low-pH treatment and this method could be applied for virus inactivation of ALG.更多还原