论文部分内容阅读
目的通过离心试验,制备出一种高纯度的流行性乙型脑炎(乙脑)灭活纯化疫苗(非洲绿猴肾细胞)[Purified Inactivated Japanese Encephalitis Vaccine(Vero Cell),JEV]。方法生物反应器培养的Vero细胞乙脑病毒液,超滤浓缩、甲醛灭活后,应用硫酸鱼精蛋白处理,再经过高速离心,蔗糖密度梯度超速离心纯化,超滤除糖,配制成JEV(Vero细胞)。结果经检测,疫苗中Vero细胞脱氧核糖核酸残留量≤10pg(皮克,Picogram)/剂,蛋白含量≤1μg(微克)/剂,宿主蛋白残留量≤30ng(纳克,Nanogram)/ml,并获得较高的抗原回收率。结论经过优化硫酸鱼精蛋白处理和蔗糖密度梯度超速离心纯化,制得了高纯度的JEV(Vero细胞)。
Objective To prepare a purified Purified Inactivated Japanese Encephalitis Vaccine (Vero Cell) (JEV) with high purity from Japanese encephalitis (JEV) purified by centrifugation. Methods Vero cells cultured in bioreactor were purified by ultrafiltration and formaldehyde inactivation, and then treated with protamine sulfate, purified by ultracentrifugation and sucrose density gradient ultracentrifugation, and filtered through ultrafiltration to prepare JEV ( Vero cells). Results The Vero cell DNA residues in the vaccine were ≤10 pg Picogram / dose, protein content ≤1 μg / dose, host protein residue ≤30 ng Nanogram / ml, Get a higher antigen recovery. Conclusion High purity of JEV (Vero cells) was obtained after optimized protamine sulfate treatment and sucrose density gradient ultracentrifugation.