人二倍体甲型肝炎灭活疫苗纯化技术的研究

Research of the Purification Technology of Inactivated Human Diploid Hepatitis A Vaccine

研究人二倍体细胞甲型肝炎灭活疫苗的纯化方法。经人二倍体细胞培养的病毒液经澄清、浓缩后制成粗制疫苗,采用Sephacryl S400、DEAE-Sepharose FF、Sephadex G-10等柱层析手段进行纯化。试验证明甲型肝炎病毒粗制疫苗经以上3种层析柱纯化后,抗原组分单一,收率达到85%,杂蛋白去除率达85%以上,蛋白总含量、牛血清残留量各项指标符合中国药典要求,适用于大规模生产。

Purification method of human diploid cell hepatitis A inactivated vaccine was studied. Liquid of hepatitis A virus cultured with human diploid cell was levigated and enriched to prepare crude vaccine. Then it was purified by means of Sephacryl S-400, DEAE-Sepharose FF, and Sephadex G-IO column chromatography. The results showed that the antigen of hepatitis A virus purified by three kinds of column chromatography mentioned above, the component of antigen was singular with recovery rate as high as 85% , and the depletion of the hetero-protein was over 85%. The content of total protein and various indices of BSA residue were all suitable to the Pharmacopoeia of the People＇ s Republic of China, and it is appropriate to produce in large scale.