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目的建立免疫复合物型增效乙型肝炎疫苗鉴别试验方法。方法分别应用酸性缓冲液Gly-HCl、HAc-NaAc、Na2HPO4-CA、CA-NaCA和表面活性剂DEA-T处理免疫复合物型增效乙型肝炎疫苗,采用ELISA法检测处理后疫苗中的HBsAg和HBIG,筛选最佳缓冲液;对鉴别试验的反应条件(pH值、反应时间、反应温度)进行优化;并对鉴别试验的精密性进行验证。结果选择CA-NaCA缓冲液作为免疫复合物型增效乙型肝炎疫苗鉴别试验的样品处理缓冲液,其既具有解离抗原抗体复合物的作用,又能使铝佐剂与吸附的蛋白质解离;鉴别试验最适pH值为3.0,最佳反应温度为25℃,最佳反应时间为30 min;该鉴别试验方法精密性良好。结论 建立了免疫复合物型增效乙型肝炎疫苗鉴别试验方法,为该疫苗的检定方法提供了必要的补充。
Objective To establish an immunocomplex-type hepatitis B vaccine identification test. Methods Immunocomplex-type hepatitis B vaccine was treated with acid buffer Gly-HCl, HAc-NaAc, Na2HPO4-CA, CA-NaCA and surfactant DEA-T respectively. The HBsAg And HBIG, screening the best buffer; optimizing the reaction conditions (pH value, reaction time, reaction temperature) of the identification test; and verifying the precision of the identification test. Results CA-NaCA buffer was selected as the sample processing buffer for the immunocomplex-type hepatitis B vaccine differential test, which not only dissociated the antigen-antibody complex but also dissociated the aluminum adjuvant from the adsorbed protein The optimum pH value of the identification test was 3.0, the optimal reaction temperature was 25 ℃ and the optimum reaction time was 30 min. The identification test method was of good precision. Conclusion The immune complex-based hepatitis B vaccine identification test method was established, which provided the necessary supplement for the vaccine test method.