猪支原体肺炎活疫苗（168株）生产工艺关键技术研究

摘要

It is strictly hard for culturing and storage of Mycoplasma hyopneumoniae （ Mhp）, which is the technical problem of vaccine integrated production. We screened four kind of culture medias of Mhp, and the color - changing units （CCU） detection results showed that Mhp strain 168 grew well in low -serum modified medium. For the optimization of the fermentation technology, the peak titers of highest growth of 168 strain, were 10^10 CCU /mL after cultured 60 - 70 h in fermentor. With optimization of heat resisting protective and lyophilization technology, the titers of 168 strain were only reduced 10^0.5 CCU/mL during the aging tolerance test which lasted for 10 d at condition of 37℃. This study built the foundation for the efficient, safety and stabile producing the Mhp live vaccines.%肺炎支原体的培养和保存条件非常苛刻，是疫苗规模化生产的工艺难题。本文针对猪支原体肺炎活疫苗（168株）生产工艺关键技术进行研究。通过培养试验筛选四种培养基配方表明该疫苗株在低血清改良培养基中生长良好；优化发酵培养工艺，使其在发酵罐培养60—70h的峰值可达到10mCCU／mL；设计筛选该疫苗耐热保护剂和冻干工艺，37℃下保存10d的耐老化试验结果显示，下降滴度小于10^0.5CCU／mL。本研究为提供高效、安全和稳定的猪肺炎支原体疫苗产品奠定基础。