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目的 探讨免疫献血员获得高效价HBsAb的免疫程序和免疫剂量,制备人乙型肝炎免疫球蛋白。方法 对适龄健康献血员按HBsAb效价进行分组,分别采用不同剂量乙型肝炎疫苗和不同的免疫程序进行接种,用ELISA定量检测其HBsAb效价;效价>8IU/ml的原料血浆合并,采用低温乙醇法制备人乙型肝炎免疫球蛋白。结果 乙型肝炎抗体阴性献血员组内不同免疫程序和不同抗原剂量产生高效价HBsAb的比率差异无显著意义;抗体阳性献血员组内高剂量免疫产生高效价HBsAb的比率明显高于低剂量免疫的结果;制备的人乙型肝炎免疫球蛋白质量指标均符合中国生物制品规程标准。结论 采用0、1、2的免疫程序、20μg乙型肝炎疫苗免疫HBsAb阳性的献血员可获得高效价原料血浆,用于乙肝免疫球蛋白的制备。
OBJECTIVE: To investigate the immune procedure and immunological dose of high titer HBsAb for immunized donors to prepare human hepatitis B immunoglobulin. Methods HBsAb titers of healthy blood donors were divided into different groups and vaccinated with different doses of hepatitis B vaccine and different immunization programs respectively. The titers of HBsAb were measured by ELISA. Raw blood plasma with titers> 8IU / ml was combined with Preparation of Human Hepatitis B Immunoglobulin by Low Temperature Ethanol Method. Results There was no significant difference in the rates of HBsAb produced by different immunization programs and different antigen doses in the negative donor blood group of hepatitis B antibody. The rate of high titer HBsAb produced by high dose immunization in the group of antibody positive donors was significantly higher than that of the low dose immunized Results The quality indexes of prepared human hepatitis B immunoglobulin were in accordance with the standards of Chinese biological products. Conclusion The immunization procedure with 0, 1 and 2 doses of 20μg Hepatitis B vaccine can immunize HBsAb-positive donors to obtain high titer crude plasma for the preparation of hepatitis B immunoglobulin.