冻干人用狂犬病疫苗(Vero细胞)稳定剂配方的筛选

Optimal selection of stabilizer formulation applied to rabies vaccine( Vero cell) for human use

目的筛选出适合冻干人用狂犬病疫苗(Vero细胞)的热稳定性好、无明胶的稳定剂配方。方法以水分、外观、效价、热稳定性效价为指标,尤其是效价和热稳定性效价,对A、B、C、D、E、F、G等6种稳定剂配方进行系统的优化组合筛选,6种稳定剂配方分别含有蔗糖、乳糖、人血白蛋白、甘氨酸、精氨酸、明胶、尿素、甘露醇、右旋糖苷,其中A为现行疫苗生产配方。运用单因素五元设计法,筛选出最优稳定剂组合。结果方差分析结果显示D组配方对冻干人用狂犬病疫苗(Vero细胞)的M-ABT结果 13.95,37℃放置4周M-ABT结果 13.05;NIH效价1.94,37℃放置4周NIH效价1.56。结论 D组配方对冻干人用狂犬病疫苗(Vero细胞)有较好的保护作用。

Objective To select a sort of stabilizer formulation without gelatin and with a favorable thermal stability suitable to rabies vaccine（ Vero cell） for human use. Methods The water content,outlooking,titer and titer of thermal stability were processed in an optimal selection of A,B,C,D,E,F,G six kinds of formulations with different ingredients systematically. The formulations were composed of sucrose,lactose,human serum albumin,glycin,arginine,gelatin,urea,mycose and dextran,respectively. A is a conventional formulation to produce rabies vaccine（ Vero cell） for human use. The optimal formulation was selected by single factor analysis of five agents. Results The result of variance（ ANOVA） analysis showed that M-ABT of D formulation is 13. 95 in preparation of rabies vaccine,M-ABT is 13. 05 for keeping the vaccine for four weeks in 37 ℃. Titer of NIH is 1. 94,Titer of NIH is 1. 56 for for keeping the vaccine for four weeks in 37 ℃.Conclusion The protective effect from D formulation in preparation of rabies vaccine（ Vero cell） for human use is better than the other formulations.