年产1亿支水痘减毒活疫苗生产工艺设计.docx

四川轻化工大学本科课程设计 目录 年产1亿支水痘减毒活疫苗生产工艺设计 姓 名： 学 号： 专 业： 班 级： 指导教师： 化学工程学院 二〇二〇年十二月 PAGE PAGE I 摘要 本文向大家介绍水痘急性传染病原由，疫苗是什么及其作用。目前生产水痘减毒活疫苗所用的菌株主要为V-Oka疫苗株，水痘减毒活疫苗生产工艺流程大致分为原液制备和冻干制剂两个阶段。原液制备阶段主要分为细胞培养阶段和病毒培养阶段两个阶段。冻干制剂又主要分为半成品制备和冻干工艺。水痘减毒活疫苗要直接接种入人体内，要严格按照中国药品GMP规定进行每一步的生产。本文将介绍年产1亿支水痘减毒活疫苗的生产工艺。 关键词：水痘；疫苗；水痘减毒活疫苗；冻干制剂 PAGE PAGE II ABSTRACT This?article?introduces?the?cause?of?acute?varicella?infection,?what?is?the?vaccine?and?its?function.?At?present,?the?main?strain?used?in?the?production?of?live?attenuated?varicella?vaccine?is?v-oka?vaccine?strain.?The?production?process?of?live?attenuated?varicella?vaccine?is?roughly?divided?into?two?stages:?stock?solution?preparation?and?freeze-dried?preparation.?The?preparation?stage?of?stock?solution?is?mainly?divided?into?two?stages:?cell?culture?stage?and?virus?culture?stage.?Freeze?dried?preparations?are?mainly?divided?into?semi-finished?product?preparation?and?freeze-dried?process.?Live?attenuated?varicella?vaccine?should?be?directly?inoculated?into?human?body,?and?every?step?of?production?should?be?carried?out?in?strict?accordance?with?the?provisions?of?Chinese?GMP.This?article?will?introduce?the?production?technology?of?100?million?live?attenuated?varicella?vaccines?per?year. Key words:chicken?pox; vaccines; Varicella?Vaccine; Lyophilized?preparation 四川轻化工大学本科毕业论文 设计资料 PAGE PAGE I IV IV III III 目录 TOC \o 1-4 \h \u 摘要 I ABSTRACT II 第一章 绪论 1 1.1 水痘 1 1.2 疫苗 1 1.2.1 疫苗的定义 1 1.2.2 疫苗的分类 1 1.2.3 疫苗的类别