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作 者:罗勇[1] 于荣清[1] 兰芳[1] 田继钊 张锐[1]
机构地区:[1]成都生物制品研究所有限责任公司,四川成都610023
出 处:《中国生物制品学杂志》2016年第12期1271-1273,1279,共4页Chinese Journal of Biologicals
摘 要:目的对植物蛋白胨培养基应用于23价肺炎球菌多糖疫苗规模化生产的效果进行初步评价。方法采用植物蛋白胨培养基,按生产规模进行肺炎球菌发酵培养和分离纯化多糖,检测大罐培养浓度、培养液多糖含量及精制多糖各项质量指标,并与现有23价肺炎球菌多糖疫苗生产用动物蛋白胨培养基相比较。结果与动物蛋白胨培养基相比较,使用植物蛋白胨培养基可提高肺炎球菌大罐培养浓度以及培养液多糖含量;精制多糖收率明显提高,各项质量指标均符合企业注册标准要求。结论在生产规模下,使用植物蛋白胨培养基生产的肺炎球菌精制多糖质量符合企业注册标准,且可较大幅度地提高精制多糖收率,为植物蛋白胨培养基应用于23价肺炎球菌多糖疫苗规模化生产奠定了基础。Objective To primarily evaluate the application of phytone medium in production of 23-valent pneumococcal polysaccharide vaccine. Methods Pneumococcus was cultured in phytone medium in fermentor in a production scale,from which polysaccharides were isolated and purified. The culture concentration in fermentor, concentration of polysaccharide in culture supernatant and quality of purified polysaccharides were determined, and compared with those of the peptone medium for production of 23-valent pneumococcal polysaccharide vaccine. Results The culture concentration of pneumococcus in fermentor and concentration of polysaccharide in the culture supernatant in phytone medium increased as compared with those in peptone medium, and the yield of polysaccharides increased significantly, and the quality indexes of the polysaccharides met the requirements for registration. Conclusion The quality of purified pneumococcal polysaccharide prepared with phytone medium in a production scale met the requirements for registration, while the yield increased significantly. It laid a foundation of application of phytone medium in production of 23-valent pneumococcal polysaccharide vaccine.
关 键 词:植物蛋白胨培养基 23价肺炎球菌多糖疫苗
分 类 号:R378.14[医药卫生—病原生物学] R392.33[医药卫生—基础医学]
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