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:目的 在生产规模条件下 ,对悬浮和单层吸附方法应用于H2 株甲肝减毒活疫苗生产进行了 5年产量质量及人体免疫效果的比较。方法 采用悬浮吸附方法和单层吸附方法并进行比较。结果 悬浮吸附方法HAV增殖高峰比单层吸附方法提前 4天 ,抗原滴度高一个稀释度 ,病毒繁殖全程细胞质量优于单层吸附方法 ,整个生产周期可缩短 9天。历年大规模对比生产和人体免疫效果观察结果表明 :悬浮吸附方法生产甲肝疫苗滴度略高于单层吸附方法 ,两者生产的疫苗在人体免疫效果方面无显著差异。结论 悬浮吸附方法更适宜H2 株甲肝减毒活疫苗工业化、规模化生产。
: Objective To compare the five-year yield and human immunization effects of the suspension and monolayer adsorption methods applied to live attenuated attenuated hepatitis A virus vaccine in the production scale. Methods Suspension adsorption method and monolayer adsorption method were compared. Results The peak of proliferation of HAV by suspension method was 4 days earlier than monolayer adsorption method. The titer of antigen was higher than that of monolayer. The cell mass of virus propagation was better than that of monolayer adsorption. The whole production cycle could be shortened by 9 days. The results of large-scale comparative production and human immune effect over the years showed that the titer of the HAV vaccine produced by the suspension adsorption method is slightly higher than that of the monolayer adsorption method, and the vaccines produced by the two have no significant difference in the human immune effect. Conclusion Suspension adsorption method is more suitable for the industrialization and large-scale production of H2 strain live attenuated attenuated hepatitis A vaccine.