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目的 :为提高重组乙肝疫苗的产量与质量 ,研究了纯化工艺最后一步凝胶过滤柱层析的重组HBsAg聚合蛋白。方法 :采用超声与DNA酶处理 ,凝胶过滤柱层析的步聚回收重组HBsAg。结果 :重组HBsAg纯化工艺的终收率从 35 %左右提高到 48%。重组乙肝疫苗的细胞免疫原性有了增强。结论 :以回收的重组HBsAg制备的重组乙肝疫苗在纯度、免疫原性和稳定性方面达到了世界卫生组织的标准。
OBJECTIVE: To improve the yield and quality of recombinant hepatitis B vaccine, the recombinant HBsAg was studied by gel filtration chromatography in the final step of the purification process. Methods: Ultrasound and DNA enzyme treatment, gel filtration column chromatography step recovery of recombinant HBsAg. Results: The final recovery rate of recombinant HBsAg purification process increased from 35% to 48%. The immunogenicity of recombinant hepatitis B vaccine has been enhanced. CONCLUSION: Recombinant hepatitis B vaccine prepared with the recovered recombinant HBsAg meets the WHO criteria for purity, immunogenicity and stability.