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1型、9V型、19A型肺炎球菌多糖-破伤风类毒素（tetanus toxoid,TT）结合物原液的稳定性。方法 以CDAP作为活化剂，制备3个型别的多糖TT结合物原液各3批，于2~8 ℃条件下保存12个月，定期取样检测，评价其稳定性。结果  不同型别的多糖-TT结合物原液在2~8 ℃条件下保存12个月，其主要检测项目均符合质量要求，游离TT含量低于30.0%，游离蛋白含量低于5%，分配系数≤0.35的多糖回收率均>60%。结论  1型、9V型、19A型肺炎球菌荚膜多糖-TT结合物原液在本研究条件下具有良好的稳定性。

Objective  To evaluate the stability of type 1, type 9V, and type 19A Streptococcus pneumoniae polysaccharide-tetanus toxoid (TT) conjugate prepared with polysaccharides activated by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate (CDAP). Methods  With CDAP as an activator, 3 types of polysaccharide-TT conjugates, each 3 consecutive batches, were prepared and kept at 2-8 ℃ for 12 months and evaluated of stability at scheduled time. Results  Stored at 2-8 °C for 12 months, the all polysaccharide- protein conjugates met the quality standard. The result included the free polysaccharide content lower than 30.0%，the free TT content lower than 5%, the recovery rate of K_D≤0.35 polysaccharides higher than 60% . Conclusion  Type 1, type 9V and type 19A polysaccharide-TT conjugates have good stability.