五价口服轮状病毒活疫苗稳定剂的初步优化  

Preliminary optimization of stabilizer for pentavalent oral rotavirus vaccine(live)

作　　者：张改梅[1,2] 殷建齐 尹珊珊[2] 朱芮波[2] 甘建辉 肖坚 胡光楠[3] 刘建凯[2] 

机构地区：[1]深圳康泰生物制品股份有限公司,广东深圳518057 [2]北京民海生物科技有限公司研发中心新型疫苗研制技术国家地方联合工程实验室,北京102600 [3]马萨诸塞大学医学院,伍斯特01655

出　　处：《中国生物制品学杂志》2016年第7期678-680,685,共4页Chinese Journal of Biologicals

基　　金：深圳市战略新兴产业发展专项(CXZZ20140417145917540)

摘　　要：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 formula of stabilizer for pentavalent oral rotavirus vaccine（live）.Methods The stabilizers A（consisting of sucrose,sodium succinate,succinic acid,and sodium glutamate）,B（consisting of sucrose,sodium citrate,citric acid and sorbitol） and C（consisting of mannitol,disodium hydrogen phosphate,sodium dihydrogen phosphate） were optimized by orthogonal design using the virus titer after storage at 37 ℃ for one week as an indicator.Results The optimal formula of stabilizer A consisted of 40% sucrose,0.2 mol/L sodium succinate,0.01 mol/L succinic acid and 0.05 mol/L sodium glutamate,while that of stabilizer B consisted for 40% sucrose,0.1 mol/L sodium citrate,0.005 mol/L citric acid and 1% sorbitol,and that of stabilizer C consisted of 40% sucrose,0.1 mol/L disodium hydrogen phosphate,0.005 mol/L sodium dihydrogen phosphate and 0.5% mannitol.Conclusion All the three stabilizers showed good protective effect on pentavalent oral rotavirus vaccine（live）.

关 键 词：口服轮状病毒活疫苗 稳定剂 优化 

分 类 号：R373.25[医药卫生—病原生物学] R392-33[医药卫生—基础医学]