冻干水痘减毒活疫苗转瓶生产工艺及质量控制的研究

发布时间：2018-03-04 05:28

本文选题：冻干水痘减毒活疫苗　切入点：旋转培养　出处：《吉林大学》2008年硕士论文　论文类型：学位论文

【摘要】： 水痘是一种多发性、高度传染性疾病,以儿童发病为主。水痘发病是由水痘-带状疱疹病毒(VZV)传染所致,易感染者接触后发病率高达80-90%。我国是世界上水痘流行最为严重的国家之一,水痘及带状疱疹危害着我国人民,特别是儿童的健康。预防水痘最安全和有效的措施是接种水痘疫苗,冻干水痘减毒活疫苗作为预防水痘-带状疱疹病毒的唯一有效制剂,自1974年Oka株水痘减毒活疫苗问世以后,欧美等国也陆续开始了水痘疫苗生产,但其生产工艺均采用静止培养。长春生物制品研究所1994年开始立题研制冻干水痘疫苗,生产初期,也采用克氏瓶静止培养生产工艺,但其生产工艺中的弊端愈见明显。本课题是为了提高水痘疫苗单产,降低疫苗中的牛血清蛋白残留量,扩大生产规模,将旋转培养生产工艺应用于水痘疫苗生产。经转瓶生产工艺生产的疫苗与克氏瓶相比,按常规检定,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。
[Abstract]:Chickenpox is a multiple, highly infectious disease, mainly in children. Chickenpox is caused by varicella-zoster virus (VZV) infection. The incidence of vulnerable infections is as high as 80-900.China is one of the countries with the most serious prevalence of chickenpox in the world, and chickenpox and herpes zoster are harming our people. Especially the health of children. The safest and most effective measure to prevent varicella is to inoculate varicella vaccine. Freeze-dried live attenuated varicella vaccine is the only effective preparation for the prevention of varicella zoster virus. Since the advent of the live attenuated varicella vaccine of Oka strain in 1974, In Europe and the United States and other countries, the production of varicella vaccine has started one after another, but its production process is all static culture. Changchun Institute of Biological products began to develop freeze-dried varicella vaccine in 1994. In the early stage of production, the production process of static culture of Kirschner bottle was also used. However, the disadvantages in the production process are more obvious. The purpose of this project is to increase the unit production of varicella vaccine, reduce the residue of bovine serum protein in the vaccine, and expand the scale of production. The rotary culture production process was applied to the production of varicella vaccine. Compared with Kirschner bottle, the vaccine produced by rotary culture process not only increased the unit production of vaccine, but also reduced the residue of bovine serum protein. And the quality of the vaccine remains stable.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2008
【分类号】：R392

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