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目的优化口服重组幽门螺杆菌疫苗的冻干工艺,以降低冻干过程中制剂瓶的破瓶率。方法通过改变冻干工艺中预冻、升华干燥、解析干燥阶段的工艺参数,对12批口服重组幽门螺杆菌疫苗进行冻干试验,在保证样品外观、水分、p H值及无菌检查合格的前提下,以制剂瓶的破瓶率为指标筛选最优冻干工艺。结果口服重组幽门螺杆菌疫苗的最优冻干工艺条件为:预冻期2 h内冷冻至-45℃并维持4.5 h;升华干燥时阶段性升温,总历时34 h;解析干燥时28℃维持12 h。按此工艺冻干后的口服重组幽门螺杆菌疫苗样品的外观、水分、p H值及无菌检查均在合格范围内,且制剂瓶的破瓶率为0。结论优化后的口服重组幽门螺杆菌疫苗冻干工艺稳定可靠,为今后的大规模生产奠定了基础。
OBJECTIVE To optimize the freeze-drying process of oral recombinant H. pylori vaccine to reduce the rate of bottle shattering in formulation bottles during lyophilization. Methods Twelve freeze-dried recombinant Helicobacter pylori vaccines were prepared by changing the parameters of pre-freeze, sublimation and drying in the freeze-drying process and analyzing the drying stage. The freeze-drying test was conducted to ensure the appearance, water content, p H value and sterility Under the premise, the bottles of bottles of preparation bottles as the index screening the optimal freeze-drying process. Results The optimal conditions for the freeze-drying of oral recombinant H. pylori vaccine were as follows: frozen to -45 ° C within 2 h of pre-freezing and maintained for 4.5 h; phased warming during sublimation and drying for a total of 34 h; 12 h. The appearance, water content, p H value and sterility of oral recombinant H. pylori vaccine samples lyophilized according to the process were within the acceptable range and the bottle-breaking rate of the preparation bottle was zero. Conclusion The optimized freeze-dried recombinant Helicobacter pylori vaccine is stable and reliable, which lays the foundation for mass production in the future.