冻干水痘减毒活疫苗转瓶生产工艺的建立

应用旋转培养的方法，建立冻干水痘减毒活疫苗的生产工艺。选择长成致密单层的2BS细胞，接种带状疱疹病毒Oka株，待细胞病变达75％以上时，收获病毒液，经超声破碎、离心、澄清，冻干后，按常规检定，疫苗各项检定符合《WHO水痘活疫苗规程》及《冻干水痘减毒活疫苗制造及检定试行规程》要求。与克氏瓶相比，应用旋转培养，不但提高了疫苗单产，降低了牛血清蛋白残留量，而且疫苗质量也保持稳定。

Establishment of the production process of freeze-dried live attenuated varicella vaccine with roller bottle

The production process was established for preparing freeze-dr ied attenuated varicella vaccine with roller bottle.The Oka-varicella-zoster virus was inoculates in a dense 2BS cells monolayer.The virus suspension was harvestesd when cytopathic effect(CPE)was above 75%. The general detection was carried out after the virus suspension was ultrasonic disrupted, centrifuged,clarified and freeze-dried.The detection results were in accordance with the WHO requirements for vericella vaccine and freeze-dried live attenuated varicella vaccine.It suggested that the production and quality of vaccine were increased,the residual bovine serum decreased by roller bottle method than those with the claisen flask do.