正交试验优化鼠疫活疫苗冻干稳定剂

Optimization of lyophilized stabilizer for plague vaccine with orthogonal design

目的优化皮上划痕用鼠疫活疫苗的稳定剂配方。方法采用正交试验,以鼠疫杆菌冻干存活率为检测指标,分别对乳糖、谷氨酸钠、硫脲和尿素4种成分组成的稳定剂配方,以及乳糖、蔗糖、谷氨酸钠、硫脲和尿素5种成分组成的稳定剂配方进行优化。结果 4种成分组成的稳定剂最佳组合为乳糖7.5%、谷氨酸钠0.5%、硫脲1.0%、尿素0.1%(均为质量分数),此配方可使菌体的冻干存活率达到(68.49±6.19)%;5种成分组成的冻干稳定剂最佳组合为乳糖7.5%、蔗糖7.5%、谷氨酸钠0.5%、硫脲0.5%、尿素0.1%(均为质量分数),此配方可使菌体的冻干存活率达到(74.71±6.34)%,均高于现有稳定剂配方。结论优化的两种稳定剂均对鼠疫杆菌具有较好的保护作用。

Objective To select the optimum formulation of lyophilized stabilizer for plague live vaccine. Methods Using orthogonal design, viable count was used as an index, the four components formulation （containing lactose, sodium gluta- mate, thiourea and urea） was compared with the five components formulation （ add in sucrose ）. Results In the best com- position conditions of 7.5% lactose, 0.5% sodium glutamate, 1.0% thiourea and 0.1% urea the survival cells rate can reach 68.49%. Under the best five component conditions of 7.5% lactose, 7.5% sucrose, 0.5% sodium glutamate, 0.5% thiourea and 0.1% urea the survival cells rate can reach 74.71%. Conclusions The two formulated stabilizers are optimized and they have the good protective effect for plague live vaccine.