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作 者:韩亮[1] 王晓宏[1] 惠连[1] 郝富勇[1] 赵丽红[1] 王伟[1] 赵建[1] 柳梅[1] 姜慧贤[1] 于学洁[1] 回良杰[1] 孙俊峰[1]
出 处:《微生物学免疫学进展》2002年第1期36-38,共3页Progress In Microbiology and Immunology
摘 要:为研制包含Ⅰ型和Ⅱ型病毒抗原的肾综合征出血热双价灭活疫苗 ,以适合全国各出血热疫区使用。通过空斑克隆和终末稀释传代的方法选育了 2株出血热I型病毒PS 6和JR C 1。用金黄地鼠肾细胞培养的L99株(Ⅱ型 )病毒疫苗 ,PS 6株病毒疫苗和JR C 1株病毒疫苗以 2∶1∶1的配伍方式试制三批双价疫苗。结果试制的三批双价疫苗自检和中国药品生物制品检定所复检 ,各项指标全部合格。疫苗于室温放置 3周 ,3 7℃放置 2周和 4℃放置 1年、1 5年和 2年 ,效力试验均合格。研制的三批出血热双价疫苗 ,符合《肾综合症出血热灭活疫苗 (双价 )试行规程》的要求 。The preparation of bivalent inactivated HFRS vaccine containing type I and type Ⅱ virus,in order to use in all HFRS endemic areas of the country.Hantavirus PS 6 strain and JR C 1 strain were selected by the methods of plaque clone and terminal dilution subculture.Three lots bivalent vaccins have been prepared by using strains of HFRS virus L99,PS 6 and JR C 1 at the rate of 2∶1∶1 in GHKC culture.All tests of the developmental 3 lots bivalent vaccines have been passed by self checking and reexamining of National Institute for the control of Pharmaceutical and Biological Products.The all results of the efficacy tests of the vaccines were qualified,after stored at room temperature 37℃ for 3 weeks,for 2 weeks and 4℃ for 1,1.5 and 2 year.The prepared vaccines accordance with the demands of trial execution regulations of the bivalent inactivated HFRS Vaccine.
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