人用H5N1禽流感疫苗检定评价.docVIP

人用H5N1禽流感疫苗检定评价 目录 TOC \o 1-9 \h \z \u 目录 1 正文 1 文1：人用H5N1禽流感疫苗检定评价 1 1 材料与方法 3 2 结果 3 3 讨论 5 文2：人用H5N1禽流感疫苗检定评价 6 1 材料与方法 8 2 结果 9 参考文摘引言： 9 原创性声明（模板） 11 文章致谢（模板） 11 正文 人用H5N1禽流感疫苗检定评价 文1：人用H5N1禽流感疫苗检定评价 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 better one from the two seeds was selected to immunize animals for the next 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 purified condition of the vaccines was better one from the two seeds was chosen to immunize The multiplication tite in the two viruses were higher at the inoculation titer of 104EID50/ml(02ml/egg) incubation temperature of 345℃ and incubation time of three 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 form of the vaccines produced by the three techniques was totally different with electron albumen zone form with SDSelectrophoresis 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 vaccine output with the seed R1203 was much more than that with the seed The high quality vaccines can be produced by the three production techniques for purified vaccine output with R1203 is more than that with vaccines produced by the three different techniques with the R1203 virus seeds can be used to immunize animals and to observe their antibody respoe. 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。 1 材料与方法 11