摘要
流行性出血热Ⅱ型纯化疫苗(即亚单位疫苗)系用Ⅱ型Hautaan病毒R_(22)SM株感染乳鼠脑精制而成。为了保证疫苗生产和质量控制,我们对病毒株的繁殖量,感染度,毒力及纯毒株的中和指数作了实验性检测,依据检测的结果:用Ⅱ型EHF毒株R_(22)SM株乳鼠脑内接种感染后的第4或5天病毒在脑内开始出现,而大量繁殖则在接种感染后第7~8。其单一鼠脑内病毒繁殖量(病毒滴度)和制成单一收获原液中病毒含量基本相一致;脑内病毒滴度log LD_(50)为9.7;原悬液中病毒滴度log ID_(50)为11.2,纯毒试验的特异性中和指数为1378。如上所述,各种实验检测结果完全符合EHF疫苗生产规程指标要求。
The type vaccine, actuially a purified subunt vaccine was prepared from the brain of suckling mouse infected with type Ⅱ EHF Virus R22SM strain.
The multiplicity, infectiosity, Vcrulence and neutralization index of pure seed test were examined for the manufacture and quality control of EHF vaccine. On the basis of examination showed that EHF viruses were appeared in the brain of suckling mice on 4 or 5 days i. C. inoculation with type Ⅱ R22SM Virus, but multiplication by a wide margin of virus on7~ 8 days. The virus titers ( Virus Capacity ) in the brain of suckling mice and in the suspension Of monovalent virus pool for produce vaccine were essentially in agreement: log LD50 of the former were 9.7and log ID50 of the latter were 11.2, The Neutralization index by an in-dentity test of R22SM strain were 1378. As mentioned above, it is ilustraled that various experimental parameters were wholly up to standard of the manufacturing requiremet of EHF vaccine.
出处
《微生物学免疫学进展》
1993年第4期9-13,共5页
Progress In Microbiology and Immunology
关键词
流行性出血热
疫苗
制备
质量检定
Epidemic haemorrhagic fever purified subunt vaccine Manuf cture and Quality control Type Ⅱ Hantaan Virus R_22SM strain