以2种培养基规模化制备6B型肺炎球菌多糖的比较研究  

Comparative research of Streptococcus pneumoniae type 6B polysaccharide large-scale production by two culture media

作　　者：于荣清[1] 兰芳[1] 南方[2] 李小波[1] 程亚刚 Yu Rongqing;Lan Fang;Nan Fang;Li Xiaobo;Cheng Yagang(Bacterial Vaccine Department 2,Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China;Quality Assurance Department,Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China)

机构地区：[1]成都生物制品研究所有限责任公司细菌性疫苗二室,成都610023 [2]成都生物制品研究所有限责任公司质量保证部,成都610023

出　　处：《国际生物制品学杂志》2024年第6期355-359,共5页International Journal of Biologicals

摘　　要：目的采用6B型肺炎链球菌为试验血清型别,比较植物源性和动物源性培养基应用于23价肺炎球菌多糖疫苗规模化生产的效果。方法采用大豆胨培养基和胰酪蛋白胨培养基各进行3批生产规模的试生产,检测肺炎球菌生长情况,在各工艺阶段采用速率比浊法测定多糖含量并计算回收率,将收获的精制多糖按照23价肺炎球菌多糖疫苗制造及检定规程进行检定,同时进行核磁共振检测,进行系统的比较分析。结果与胰酪蛋白胨培养基相比,6B型菌种在大豆胨培养基中的细菌浓度和发酵液中的多糖含量分别提高了22.5%和88.7%;生产的粗糖及精制多糖的产量平均增长了66.87%和139.67%;精制多糖各项质量指标均符合要求,2种精制多糖的核磁图谱指纹区一致,且化学位移和峰型与文献报道图谱一致。结论大豆胨培养基与胰酪蛋白胨培养基生产的6B型肺炎球菌多糖疫苗精制多糖在质量上具有可比性,且大豆胨培养基能提高精制多糖的产量。Objective To initially compare the effect of 23-valent pneumococcal polysaccharide vaccine large-scale production by the plant-derived and animal-derived culture media using Streptococcus pneumoniae type 6B as the experimental serotype.Methods Three batches of scale production were carried out for pilot production using soybean peptone culture medium and pancreatic peptone culture medium.The growth of Streptococcus pneumoniae was tested by determining the content of polysaccharide by rate turbidimetry in each process stage and calculating the recovery rate,verifying the harvested refined polysaccharide according to the manufacturing and verifications regulations of the 23-valent pneumococcal polysaccharide vaccine,and taking the nuclear magnetic resonance(NMR)detection.Then a comparative analysis was conducted systematically.Results Compared to the pancreatic peptone culture medium,in average,bacterial concentration and the polysaccharide content in fermentation broth of serotype 6B strain in soybean peptone culture medium were 22.5%and 88.7%higher,respectively,and the yield of crude polysaccharide and refined polysaccharide were 66.87%and 139.67%higher,respectively.All quality indexes of the refined polysaccharide met the requirements of the registration standards.The fingerprint areas of NMR spectra of both refined polysaccharides were consistent,and the chemical shifts and peak types were consistent with those reported in literatures.Conclusion The qualities of refined polysaccharides produced by soybean peptone medium and pancreatic peptone medium are comparable and soybean peptone medium improves the yield of refined polysaccharide.

关 键 词：肺炎链球菌 精制多糖 植物源性培养基 大豆胨 胰酪蛋白胨 

分 类 号：R392[医药卫生—免疫学]