CDAP活化多糖制备1型肺炎链球菌荚膜多糖-蛋白结合物原液的稳定性评价

目的 评价以1-氰基-4-二甲氨基-吡啶四氟硼酸盐(1-cyano-4-dimethylamino pyridinium tetrafluoroborate,CDAP)活化多糖制备的1型肺炎链球菌荚膜多糖-破伤风类毒素结合物原液的稳定性.方法 以CDAP作为活化剂,连续制备3批多糖-蛋白结合物原液,分别放置于(37±2)℃和2～8℃,定期取样检测,并评价其稳定性.结果 多糖-蛋白结合物原液在(37±2)℃条件下保存21 d,2～8℃条件下保存12个月,其主要检测指标均符合质量要求,游离多糖和游离蛋白含量分别低于30.0％和5.0％,分配系数≤0.35的多糖回收率均＞65％.结论 确定了不同条件下1型肺炎链球菌荚膜多糖-破伤风类毒素结合物原液的有效保存时间.

Stability evaluation of type 1 Streptococcus pneumoniae capsular polysaccharide-protein conjugate prepared by activating polysaccharide with CDAP

Objective To evaluate the stability of type 1 Streptococcus pneumoniae capsular polysaccharide-tetnus toxoid (TT) conjugate,prepared with polysaccharides activated by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate (CDAP).Methods With CDAP as an activator,3 consecutive batches of polysaccharide-TT conjugates were prepared and kept under 2 different temperature conditions,(37 ±2) ℃ and 2-8 ℃.To assess the stability,the conjugates were sampled periodically and detected for main indexes.Results The polysaccharide-TT conjugate samples were stable while stored at (37 ± 2) ℃ for 21 d,and at 2-8 ℃ for 12 months.All main indexes measured met the requirement of quality standards.Free polysaccharides and free TT were below 30.0％ and 5.0％,respectively.Recovery rate of polysaccharides with partition coefficient ≤ 0.35 was ＞ 65 ％.Conclusion Steady preservation time under different storage conditions is determinded of the prepared type 1 Streptococcus pneumoniae capsular polysaccharide-TT conjugate.