| | | 人用H5N1禽流感疫苗检定评价
| | 临床医学检验论文作者：朱智勇，丁晓航，朱函坪，李岩金，陈学奎，沈吉友，张涛，何培江，姚苹苹，徐芳，翁景清，龚华岳，郭志宏，苏波，孙淑滨，粱伟峰
【关键词】 禽流感疫苗；生产工艺；疫苗检定；疫苗质量
摘要： 目的临床医学检验论文 选用H5N1禽流感毒种(R1194和R1203)，按设计的临床医学检验论文生产工艺，制成的疫苗进行全面检定，选取其中较好毒株生产的疫苗，用于以后人用禽流感疫苗临床前研究的动物免疫。方法 利用从国外引进2株H5N1禽流感病毒，设计生产3种疫苗（全病毒、裂解-1、裂解-2）的纯化工艺， 优化纯化条件，全面检定制成的疫苗，比较2毒种生产疫苗的质量。结果 2毒株在接种滴度104EID50/ml（半数鸡胚感染剂量/ml），培养温度345℃，培养时间3d的条件下，病毒增殖滴度较高；检定结果证明，制成的所有疫苗中反映质量的内毒素、卵清蛋白、总蛋白、总蛋白与血凝素之比这4项指标，明显优于国家标准；3种工艺疫苗的电镜形态完全不同；经十二烷基硫酸钠聚丙烯酰胺凝胶电泳(SDS-PAGE)，全病毒疫苗和裂解-2疫苗的蛋白条带形态相似，但裂解-1疫苗在32KD左右的条带缺失；毒种R1203株疫苗的产量明显高于R1194株。结论 设计的3种生产疫苗的纯化工艺，均可生产出高质量的疫苗；毒种R1203株的疫苗产量高于毒种R1194株；可用 R1203毒株，按3种不同工艺生产的疫苗接种动物，观察免疫效果。
关键词： 禽流感疫苗；生产工艺；疫苗检定；疫苗质量
Study on avian influenza(H5N1) vaccine used in human
Abstract： Objective The vaccines were produced by the designed techniques with the seeds (R1194 and R1203) of avian influenza viruses and checked entirely.A better one from the two seeds was selected to immunize animals for the next research.Methods The three purified techniques of the vaccines (the whole viruses、split-1 and split-2) were designed and the vaccines were produced with the two imported virus seeds.The purified condition of the vaccines was perfected.A better one from the two seeds was chosen to immunize animals.Results The multiplication titers in the two viruses were higher at the inoculation titer of 104EID50/ml(02ml/egg) incubation temperature of 345℃ and incubation time of three days.The four items of endotoxin、egg-albumin、total albumin and total albumin /hemoglobin，which reflected the vaccine quality in the all produced vaccines，were better than the national standards.The form of the vaccines produced by the three techniques was totally different with electron microscopy.The albumen zone form with SDS-PAGE electrophoresis were similar in the whole virus vaccines and split-2 vaccine while the albumen zone of the split-1 vaccine could not be seen in 32KD rightandleft.The vaccine output with the seed R1203 was much more than that with the seed R1194.Conclusion The high quality vaccines can be produced by the three production techniques for purified vaccines.The vaccine output with R1203 is more than that with R1194.The vaccines produced by the three different techniques with the R1203 virus seeds can be used to immunize animals and to observe their antibody response.
Key words： avian influenza vaccine；production technique；vaccine assay;vaccine quality
在人用H5N1禽流感疫苗研究的第一部分中证实，从国外引进的R1194和R1203两株毒种为减毒株，符合目前国际用于制造人用H5N1亚型禽流感疫苗的标准。并按照我国对研制疫苗的要求，设计3种生产疫苗的纯化工艺，制造疫苗，对制成的疫苗进行全面检定，选取其中较好株毒种生产的疫苗，用于人用禽流感疫苗临床前动物免疫的研究。
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