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凍干水痘減毒活疫苗轉(zhuǎn)瓶生產(chǎn)工藝及質(zhì)量控制的研究

發(fā)布時(shí)間:2018-03-04 05:28

  本文選題:凍干水痘減毒活疫苗 切入點(diǎn):旋轉(zhuǎn)培養(yǎng) 出處:《吉林大學(xué)》2008年碩士論文 論文類型:學(xué)位論文


【摘要】: 水痘是一種多發(fā)性、高度傳染性疾病,以兒童發(fā)病為主。水痘發(fā)病是由水痘-帶狀皰疹病毒(VZV)傳染所致,易感染者接觸后發(fā)病率高達(dá)80-90%。我國是世界上水痘流行最為嚴(yán)重的國家之一,水痘及帶狀皰疹危害著我國人民,特別是兒童的健康。預(yù)防水痘最安全和有效的措施是接種水痘疫苗,凍干水痘減毒活疫苗作為預(yù)防水痘-帶狀皰疹病毒的唯一有效制劑,自1974年Oka株水痘減毒活疫苗問世以后,歐美等國也陸續(xù)開始了水痘疫苗生產(chǎn),但其生產(chǎn)工藝均采用靜止培養(yǎng)。長春生物制品研究所1994年開始立題研制凍干水痘疫苗,生產(chǎn)初期,也采用克氏瓶靜止培養(yǎng)生產(chǎn)工藝,但其生產(chǎn)工藝中的弊端愈見明顯。本課題是為了提高水痘疫苗單產(chǎn),降低疫苗中的牛血清蛋白殘留量,擴(kuò)大生產(chǎn)規(guī)模,將旋轉(zhuǎn)培養(yǎng)生產(chǎn)工藝應(yīng)用于水痘疫苗生產(chǎn)。經(jīng)轉(zhuǎn)瓶生產(chǎn)工藝生產(chǎn)的疫苗與克氏瓶相比,按常規(guī)檢定,不但提高了疫苗單產(chǎn),降低了牛血清蛋白殘留量,而且疫苗質(zhì)量也保持穩(wěn)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.
【學(xué)位授予單位】:吉林大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2008
【分類號(hào)】:R392

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