摘要
目的考察13个血清型肺炎球菌荚膜多糖在-60℃以下储存60个月的稳定性。方法将13个血清型(1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F和23F型)各3批共39批次原料多糖,-60℃以下条件储存,每隔6个月取样,分别对多糖成分基团含量、分布系数(K_D)、分子质量分布激光图谱和多糖抗原活性进行测定。检测时长为60个月。结果 60个月内39批次多糖的成分基团含量及K_D均符合质量标准;分子质量分布激光图谱并无明显变化;抗原活性良好。结论 -60℃储存条件下,13个血清型肺炎球菌原料多糖在60个月内稳定性良好。
Objective To investigate the stability of pneumococcal polysaccharide （Pn Ps） of 13 serotypes stored at -60 ℃ for 60 months. Methods Pn Ps of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, three batches for each, were stored at -60 ℃, from which samples were taken every 6 months and determined for composition content, distribution coefficient （K o） value, molecular weight distribution （HPSEC-MALLS/RI） and antigen activity. The total time length for determination was 60 months. Results The composition content and Ko value of pneumococcal polysaccharide stored at -60 ℃ for 60 months met the relevant quality standards. The results of HPSEC- MALLS/RI showed no significant change. The Pn Ps showed high antigen activity. Conclusion The pneumocoecal polysaceharide of 13 serotypes showed high stability after storage at -60℃for 36 months.
作者
任珍芸
刘倩
张轶
陈晓航
刘爱萍
王玺
熊明郁
沈荣
REN Zhen-yun;LIU Qian;ZHANG Yi;CHEN Xiao-hang;LIU Ai-ping;WANG Xi;XIONG Ming-yu;SHEN Rong First(Department of Research,Lanzhou Institute of Biological Products Co.,Ltd.,Center for Gansu Provincial Vaccine Engineering Research,Lanzhou 730046,Gansu Province,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2018年第10期1075-1083,共9页
Chinese Journal of Biologicals
基金
"十二五"国家高技术发展研究计划(863计划)疫苗研发关键技术及产品研发项目(2012AA02A401)
关键词
肺炎球菌
荚膜多糖
稳定性
有效期
Pneumococcus
Pneumococcal polysaccharide
Stability
Validity period
