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型肺炎球菌多糖-破伤风类毒素结合物原液的有效保存时间。

Object  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 is determinded of the prepared type 1 Streptococcus pneumoniae capsular polysaccharide-TT conjugate under different storage conditions.