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通过试验研究建立一种去除Vero细胞乙脑疫苗中残余细胞DNA的方法,即疫苗经超滤浓缩后加入0.8~1.0mg/ml的硫酸色精蛋白,于4℃静置2h,8000r/min离心5min。DNA与鱼精蛋白共同沉于管底。用该法处理的疫苗不仅使残余DNA达到规程要求(<100pg/剂量),而且抗原活性无明显丢失。
Through experimental research to establish a method to remove residual cell DNA in Vero cell JE vaccine, that is, the vaccine is concentrated by ultrafiltration and then added with 0.8-1.0 mg / ml of protamine sulfate, allowed to stand at 4 ° C. for 2 h and centrifuged at 8000 r / min 5min. DNA and protamine sink together in the tube bottom. Vaccines treated with this method not only make the residual DNA meet the requirements (<100pg / dose), and no significant loss of antigen activity.