摘要
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 procedure for lyophilization of of oral recombinant Helicobacter pylori vaccine so as to decrease the breakage rate of containers during lyophilization. Methods Twelve batches of oral recombinant H. pylori vaccine were subjected to lyophilization test by changing the technological parameters at steps of pre-freezing, sublimation drying and dehydration drying, and the procedure for lyophilization was optimized using the breakage rate of con-tainers based on the qualifications of appearance, moisture content, p H value and sterility. Results The procedure for lyophilization of oral recombinant H. pylori vaccine was optimized as follows：The vaccine was frozen to-45 ℃ within 2 h and maintained for 4. 5 h at step of pre-freezing, then subjected to periodic warming for 34 h at step of sublimation drying,and was maintained at 28 ℃ for 12 h at step of dehydration drying. The appearance, moisture content, p H value and sterility of the oral recombinant H. pylori vaccine were within the acceptable range, while the breakage rate of containers was zero. Conclusion The optimized procedure for lyophilization of oral recombinant H. pylori vaccine was stable and reliable, which laid a foundation of large-scale production in future.
出处
《中国生物制品学杂志》
CAS
CSCD
2015年第2期167-169,176,共4页
Chinese Journal of Biologicals
基金
国家科技重大专项子课题项目(2014ZX09102042-002)
安徽省科技攻关计划项目(1301041020)
关键词
口服重组幽门螺杆菌疫苗
冷冻干燥
优化
破瓶率
Oral recombinant Helicobacter pylori vaccine
Lyophilization
Optimization
Breakage rate of containers
