重组乙型肝炎疫苗(CHO细胞)生产工艺病毒灭活验证  

Validate the Capacity of Inactive Virus in Productive Technique of Recombinet Hepatitis B vaccine(CHO cell)

作　　者：赵小琳[1] 金立杰[1] 徐冬冬[1] 李德娟[1] 刘晔[1] 高嵩[1] 

机构地区：[1]卫生部长春生物制品研究所,吉林长春130062

出　　处：《生物技术》2006年第1期49-51,共3页Biotechnology

摘　　要：目的:验证重组乙型肝炎疫苗(CHO细胞)生产工艺灭活病毒能力,评价疫苗安全性。方法:将乙型肝炎疫苗原液按1∶9比例加入指示病毒(麻疹病毒、VSV病毒),混匀后加入甲醛溶液,使甲醛终浓度达到1/2000和1/4000,放置于37℃,分别于0h、24h、48h、72h取样,用亚硫酸氢钠中和,贮存于-70℃待检或立即检测病毒滴度,对病毒检测阴性的样品盲传3代,进一步检测。结果:疫苗原液加入1/2000和1/4000的甲醛溶液,37℃作用24h、48h、72h,麻疹病毒滴度下降4.0个Log值,VSV病毒滴度下降5.0个Log值,且细胞盲传三代,均未出现细胞病变。结论:乙型肝炎疫苗原液在1/2000和1/4000甲醛浓度37℃72h作用下,均能有效灭活麻疹病毒和VSV病毒。Objective：To validate the capacity of inactive virus in productive technique of Hepatitis B vaccine （CHO cell） and evaluate the vaccine safety of Hepatitis B vaccine （CHO cell）. Methods： After putting the indicated viruses into bulk of Hepatitis B vaccine （CHO cell） in proportion of 1 to 9, and mixing evenly, the Formaldehyde solution of different concentration were added the liquid and the final concentration of formaldehyde solution was 1/2000 and 1/4000. The samples were it in the condition of 37℃ for 0,24,48,72hours respectivcly, then neutralized the formaldehyde with sodium sulfite. The samples were stored in the condition of - 70℃ or measured the virus virulence right away. The negative samples were cultured three generations blindly for further test.Results： In the bulk of Hepatitis B vaccine with 1/2000 and 1/40000 of the formaldehyde solution was in the condition of 37℃ for 24, 48 and 72 hours, the virulence of the measles virus drops to 4.0 log and VSV varus to 5 .0 log. There is no pathological change in the cells of three generations. Conclusion： The bulk of Hepatitis B vaccine with 1/2000 and 1/4000 of the formaldehyde solution in the condition of 37℃ for 72 hours could inactivate measles virus and VSV virus effectively

关 键 词：乙型肝炎疫苗 麻疹病毒 VSV病毒 病毒灭活 

分 类 号：R392-33[医药卫生—免疫学]