喷雾干燥法制备脊髓灰质炎微球减毒活疫苗

Preparation of Live Attenuated Poliomyelitis Vaccine Microspheres by Spray Drying

目的采用喷雾干燥法制备脊髓灰质炎微球减毒活疫苗。方法以正交试验法筛选最佳保护剂配方及最佳工艺条件,通过样品的得率、含水量、病毒滴度、微球形态、粒径大小分布和热力学性质等特性评价疫苗的稳定性。结果最佳喷雾干燥工艺为:入口风温180℃,入口风压3.9m/s,进样速度2.5ml/min,保护剂配方1.5%海藻糖+0.2%人血白蛋白(HSA)+0.2%聚乙烯吡咯烷酮(PVP)(w/v)。微球形态完整,分散性好,平均粒径为10.9μm,得率为54.25%,干粉疫苗37℃放置1周和25℃保存6个月,病毒的滴度下降不超过0.5lgCCID50/ml。结论喷雾干燥法制备的脊髓灰质炎微球减毒活疫苗稳定性好,工艺简便,易于工业化生产。

Objective To prepare live attenuated poliomyelitis vaccine mirospheres by spray drying. Methods The optimal formula of protective agent and condition for preparation were screened by orthogonal test. The stability of vaccine was evaluated with yield,moisture content,virus titer,morphology of microspheres,size distribution and thermodynamic properties. Results The optimal inlet temperature,dying air speed and pump speed for spray drying were 180℃,3. 9 m / s and 2. 5 ml / min respectively. The optimal formula of protective agent was as follows：1. 5% trehalose,0. 2% human serum albumin （HSA） and 0. 2% polyvinylpyrrollidone （PVP）. The prepared microspheres showed intact shapes and good dispersity,and their mean size and yield were 10. 9 μm and 54. 25% respectively. After storage at 37℃ for 1 week and at 25℃ for 6 months,both the decreases of virus titers of prepared vaccine mirospheres were not more than 0. 5 lgCCID50 / ml. Conclusion The live attenuated poliomyelitis vaccine mirospheres prepared by spray drying showed good stability. The preparation procedure was simple and suitable for industrial production.