人用H5N1禽流感疫苗检定评价
禽流感疫苗；生产工艺；疫苗检定；疫苗质量,,禽流感疫苗；生产工艺；疫苗检定；疫苗质量,1材料与方法,2结果,3讨论,参考文献
摘要： 目的 选用H5N1禽流感毒种(R1194和R1203)，按设计的生产工艺，制成的疫苗进行全面检定，选取其中较好毒株生产的疫苗，用于以后人用禽流感疫苗临床前研究的动物免疫。方法 利用从国外引进2株H5N1禽流感病毒，设计生产3种疫苗(全病毒、裂解-1、裂解-2)的纯化工艺， 优化纯化条件，全面检定制成的疫苗，比较2毒种生产疫苗的质量。结果 2毒株在接种滴度104EID50/ml(半数鸡胚感染剂量/ml)，培养温度345℃，培养时间3d的条件下，病毒增殖滴度较高；检定结果证明，制成的所有疫苗中反映质量的内毒素、卵清蛋白、总蛋白、总蛋白与血凝素之比这4项指标，明显优于国家标准；3种工艺疫苗的电镜形态完全不同；经十二烷基硫酸钠聚丙烯酰胺凝胶电泳(SDS-PAGE)，全病毒疫苗和裂解-2疫苗的蛋白条带形态相似，但裂解-1疫苗在32KD左右的条带缺失；毒种R1203株疫苗的产量明显高于R1194株。结论 设计的3种生产疫苗的纯化工艺，均可生产出高质量的疫苗；毒种R1203株的疫苗产量高于毒种R1194株；可用 R1203毒株，按3种不同工艺生产的疫苗接种动物，观察免疫效果。关键词： 禽流感疫苗；生产工艺；疫苗检定；疫苗质量
Study on avian influenza(H5N1) vaccine used in human
ZHU Zhiyong，DING Xiaohang，ZHU Hanping，et al.
Key Lab of Vaccine against Hemorrhagic Fever with Renal Syndrome，Zhejiang Provincial Center for Disease Control and Prevention(Hangzhou 310009，China)
Abstract： Objective The vaccines were produced by the designed techniques with the seeds (R1194 and R1203) of avian influenza viruses and checked entirely.A better one from the two seeds was selected to immunize animals for the next research.Methods The three purified techniques of the vaccines (the whole viruses、split-1 and split-2) were designed and the vaccines were produced with the two imported virus seeds.The purified condition of the vaccines was perfected.A better one from the two seeds was chosen to immunize animals.Results The multiplication titers in the two viruses were higher at the inoculation titer of 104EID50/ml(02ml/egg) incubation temperature of 345℃ and incubation time of three days.The four items of endotoxin、egg-albumin、total albumin and total albumin /hemoglobin ......
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