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目的优化五价口服轮状病毒活疫苗的稳定剂配方。方法采用正交试验,以疫苗37℃放置1周的病毒滴度为检测指标,分别对A组(含蔗糖、琥珀酸钠、琥珀酸和谷氨酸钠)、B组(含蔗糖、柠檬酸钠、柠檬酸和山梨醇)、C组(含甘露醇、磷酸氢二钠、磷酸二氢钠和蔗糖)稳定剂配方进行优化。结果 A组稳定剂配方最佳组合为40%蔗糖、0.2 mol/L琥珀酸钠、0.01 mol/L琥珀酸、0.05 mol/L谷氨酸钠;B组稳定剂配方最佳组合为40%蔗糖、0.1 mol/L柠檬酸钠、0.005 mol/L柠檬酸、1%山梨醇;C组稳定剂配方最佳组合为40%蔗糖、0.1 mol/L磷酸氢二钠、0.005 mol/L磷酸二氢钠、0.5%甘露醇。结论 3种稳定剂的最佳配方均对五价口服轮状病毒活疫苗具有较好的稳定作用。
Objective To optimize the formulation of stabilizer for pentavalent oral rotavirus live vaccine. Methods The orthogonal test was used to detect the titer of virus in the vaccine for one week at 37 ℃. A (sucrose, sodium succinate and sodium glutamate), B (sucrose, citric acid Sodium, citric acid and sorbitol) and Group C (with mannitol, disodium hydrogen phosphate, sodium dihydrogen phosphate and sucrose) stabilizer formulations. Results The best combination of stabilizer formulations in group A was 40% sucrose, 0.2 mol / L sodium succinate, 0.01 mol / L succinate and 0.05 mol / L sodium glutamate. The best combination of stabilizer B in group B was 40% sucrose , 0.1 mol / L sodium citrate, 0.005 mol / L citric acid and 1% sorbitol. The optimal combination of C stabilizer was 40% sucrose, 0.1 mol / L disodium hydrogen phosphate, 0.005 mol / L dihydrogen phosphate Sodium, 0.5% mannitol. Conclusion The best formulation of the three stabilizers has a good stabilizing effect on the live vaccine of pentavalent oral rotavirus.