摘要
目的 观察不含明胶的不同保护剂配方冻干乙型脑炎灭活疫苗（Vero细胞）的稳定性.方法 在现行冻干乙型脑炎灭活疫苗制备工艺的基础上,以乳糖替代明胶,并适当增加人血白蛋白用量至5、10和20g/L,制成A、B、C三个保护剂配方疫苗.对疫苗进行25℃加速试验、37℃热稳定性试验和2～8℃长期稳定性试验,检测疫苗的有效抗原含量和效力（T值）,并与现行疫苗（对照）进行比较.结果 三个保护剂配方疫苗于25℃放置24周后,A、B疫苗有效抗原含量仅分别降低2.2％和5.9％,效力稳定；而C疫苗有效抗原含量降低13.6％,效力降低5.0％.37℃放置8周后,A、B、C疫苗有效抗原含量分别降低11.2％、13.2％、15.2％,效力分别降低5.8％、9.0％、7.2％.2～8℃放置48个月后,A、B、C疫苗有效抗原含量分别降低17.2％、18.4％、21.9％,效力均符合《冻干乙型脑炎灭活疫苗（Vero细胞）注册标准》.在上述试验中,A、B疫苗均优于或等于对照疫苗；C疫苗与对照疫苗差异较大,但均符合相关标准.结论 含A配方保护剂的冻干乙型脑炎灭活疫苗稳定性高且白蛋白用量少,因此,建议首选A配方保护剂.
Objective To observe stability of lyophilized inactivated Japanese encephalitis vaccine （Vero cell） without gelatin. Methods Lactose was used as a substitute for gelatin in the current lyophilized inactivated Japanese encephalitis vaccine. Human albumin contents were increased to 5, 10 and 20 g/L, respectively. Three vaccines （A, B and C ） were prepared and evaluated by accelerated test （25 ~C for 24 weeks）, stability test （37 ~C for 8 weeks ） and long-term stability test （2-8 ~C for 48 months ）. Effective antigen content and efficacy （T value） of the vaccines were determined and compared with those of the current vaccine. Results After 24 weeks at 25℃, effective antigen contents of A and B vaccines only reduced by 2.2% and 5.9% , respectively, and T values remained stable; however, the effective antigen and T value of C vaccine reduced by 13.6% and 5.0% , respectively. After 8 weeks at 37℃ , effective antigen contents of A, B, C vaccines reduced by 11.2%, 13.2% and 15.2%, T values reduced by 5.8%, 9.0% and 7.2%, respectively. After 48 months at 2-8℃, effective antigen contents of A, B, C vaccines reduced by 17.2% , 18.4% and 21.9% , respectively, but the T values complied with the Requirement of Registration Criteria of Lyophilized Inactivated Japanese Encephalitis Vaccine （Vero Cell）. In above tests, A and B vaccines were superior or equivalent to the control vaccine. Even though the resuhs of C vaccine were rather different from those of the control vaccine, they all met the requirement. Conclusion The A formula is considered to be the preferred choice based on the high stability of and less human albumin in A vaccine.
出处
《国际生物制品学杂志》
CAS
2013年第4期173-176,共4页
International Journal of Biologicals
关键词
日本脑炎疫苗
辅药
稳定性
Japanese encephalitis vaccines
Excipients
Stability
