中文摘要：

目的比较以牛血清白蛋白（bovine serum albumin,BSA）及破伤风类毒素（tetanus toxoid,TT）作为载体蛋白对18C型肺炎多糖结合疫苗稳定性的影响。方法采用点击化学法分别以BSA及TT作为载体蛋白制备18C型肺炎多糖结合疫苗。将2种疫苗在2~8℃条件下保存2、4、8个月,考察疫苗稳定性;分别于（25±2）℃条件下保存2、4、6周及（37±2）℃条件下保存7、14、21 d,考察疫苗的加速稳定性。每个时间点样品均进行外观检查、多糖含量、蛋白含量、pH测定、无菌检查及游离多糖含量测定。结果以TT及BSA作为载体蛋白制备的结合疫苗各项稳定性指标均符合《中国药典》三部（2010版）的相关要求,其中不同温度部分检测时间点结合物Ps-TT的游离多糖含量显著低于Ps-BSA（P〈0.05）。结论 TT作为载体蛋白制备18C型肺炎多糖结合疫苗的稳定性明显优于BSA。

英文摘要：

Objective To compare the effect of bovine serum albumin（BSA） and tetanus toxoid（TT） as carrier proteins on the stability of type 18C pneumococcal polysaccharide（Ps） vaccine. Methods Type 18C pneumococcal polysaccharide vaccine was prepared by click chemical method using BSA and TT as carrier proteins respectively, and stored at 2-8 ℃ for 2, 4, 8 months to evaluate the stability. The accelerated stability was evaluated after storage of the vaccines at （25 ± 2）℃ for 2, 4 and 6 weeks and at（37 ± 2）℃ for 7, 14 and 21 d. Samples were taken at various time points for inspection on final containers, sterility test as well as determinations of polysaccharide, protein and free polysaccharide contents and pH value. Results All the indexes of type 18C pneumococcal polysaccharide vaccines prepared using TT and BSA as carrier proteins met the requirements in Chinese Pharmacopoeia（Volume Ⅲ, 2010 edition）. However, the free polysaccharide contents in conjugate Ps-TT at partial time points after storage at various temperatures were significantly lower than those of Ps-BSA（P〈0. 05）. Conclusion The stability of type 18C pneumococcal polysaccharide vaccine prepared using TT as carrier protein was significantly higher than that using BSA.