肾综合征出血热双价纯化疫苗的研制  

Development of purified HFRS bivalent vaccine

作　　者：杨世龙[1] 董关木[2] 李娟[1] 安祺[2] 孙晓东[1] 孙小慧[1] 李萍[1] 

机构地区：[1]兰州生物制品研究所,甘肃兰州730046 [2]中国药品生物制品检定所,北京100050

出　　处：《细胞与分子免疫学杂志》2005年第2期243-245,共3页Chinese Journal of Cellular and Molecular Immunology

基　　金：国家"九五"医学攻关项目(No. 96 906 03 14)

摘　　要：　目的: 研制肾综合征出血热双价纯化疫苗。方法:肾综合征出血热病毒I型LR1 株和II型R22株分别在Vero细胞上接种培养。I、II型病毒培养液依次经β 丙内酯灭活、超滤浓缩、蔗糖区带离心纯化及层析脱糖等处理。将检定合格的I、II型单价病毒原液等量混合后, 用AI(OH)3 佐剂吸附,制备 3批双价纯化疫苗。结果: 该 3批疫苗已经自检和中国药品生物制品检定所复检合格, 并已进行临床试验。结论: 采用Vero细胞培养制备肾综合征出血热双价纯化疫苗方法可行。AIM: To develop the purified HFRS bivalent vaccine. METHODS: LR 1 ( type I ) and R 22 ( type II ) of HFRS virus were cultured respectively in Vero cells. The viral suspensions were harvested, inactivated with beta-propiolactone, concentrated by ultra-filtration, purified by zone centrifugation, and desucrosed by column chromatography. The qualified vaccine bulks of type I and type II were mixed equally and absorbed with AI(OH) 3 for preparation of 3 lots vaccines. RESULTS: The 3 lots vaccines all passed examimation carried out by ourselves and reexamination performed by National Institute for the Control of Pharmacentical and Biological Products . One of 3 lots has been used in clinical trial. CONCLUSION: It is practical to develop the purified HFRS bivalent vaccine by Vero cell culture.

关 键 词：肾综合征出血热 双价疫苗 VERO细胞 

分 类 号：R392.11[医药卫生—免疫学]