重组乙型肝炎疫苗(酵母)快速鉴别试验方法的建立  

Development of a method for rapid identity test on recombinant hepatitis B vaccine(yeast)

作　　者：王静[1] 白亦昊[1] 周长明[1] 纪宏[1] 武晗燕[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国生物制品学杂志》2013年第9期1334-1336,共3页Chinese Journal of Biologicals

摘　　要：目的建立重组乙型肝炎疫苗(酵母)快速鉴别试验方法。方法选取不同的处理液对吸附铝佐剂的3批重组乙型肝炎疫苗(酿酒酵母)进行解离,采用胶体金法检测乙型肝炎病毒表面抗原(HBsAg),筛选快速鉴别试验的最佳处理液;优化快速鉴别试验的反应温度和反应时间,并对该方法进行特异性、灵敏度和重复性验证。结果处理液A(10%Triton X-100 0.20 ml、20%二乙醇胺1.25 ml、0.01 mol/L PBS 8.55 ml)为重组乙型肝炎疫苗快速鉴别试验的最佳样品处理液;快速鉴别试验的最佳反应温度为25℃,最佳反应时间为15 min;该方法特异性较强,重复性良好,最低检出限为1.375μg/ml。结论建立了重组乙型肝炎疫苗(酵母)快速鉴别试验方法,为该疫苗的快速鉴别提供了参考。Objective To develop a method for rapid identity test on recombinant hepatitis B （HB） vaccine （yeast）. Methods Three batches of recombinant HB vaccine containing aluminium adjuvant were dissociated with various treat- ment solutions and determined for HBsAg with colloidal gold stripes to screen the optimal treatment solution. The reaction temperature and reaction time for rapid identity test were optimized, and the developed method was verified for specificity, sensitivity and reproducibility. Results Treatment solution A, containing 0. 20 ml of 10% Triton X-100, 1. 25 ml of 20% diethanol amine and 8. 55 ml of 0. 01 mol/L PBS, was screened as optimal treatment solution for rapid identity test on recombinant HB vaccine （yeast）. The optimal temperature and reaction time for the test were 25℃ and 15 min respective- ly. The developed method showed high specificity and high reproducibility, by which the minimum detection limit was 1. 375 μg/ml. Conclusion A method for rapid identity test on recombinant HB vaccine （yeast） was developed, which provided a reference for rapid identification of the vaccine.

关 键 词：重组乙型肝炎疫苗 酵母 快速鉴别试验 

分 类 号：R373.21[医药卫生—病原生物学] R392.33[医药卫生—基础医学]