低pH病毒灭活工艺对抗人淋巴细胞免疫球蛋白质量的影响  

The Influence of Low-pH Incubation on Quality of Anti-Lymphocyte Immunoglobulin

作　　者：康光明[1] 王前喜[1] 艾智武[1] 邹莉[1] 陶柳宏[1] 俞霖[1] 李萍[1] 吴克[1] 

机构地区：[1]武汉生物制品研究所,武汉430060

出　　处：《同济医科大学学报》2001年第5期505-507,共3页Acta Universitatis Medicinae Tongji

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。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.

关 键 词：抗人淋巴细胞免疫球蛋白 病毒灭活 免疫效价 免疫球蛋白 

分 类 号：R392.11[医药卫生—免疫学] R392－33[医药卫生—基础医学]