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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。
Objective To compare the effects of bovine serum albumin (BSA) and tetanus toxoid (TT) on the stability of 18C pneumococcal conjugate vaccine. Methods Click chemistry was used to prepare 18C pneumococcal polysaccharide conjugate vaccine with BSA and TT as carrier proteins respectively. The two vaccines were stored for 2, 4 and 8 months at 2-8 ℃, and the stability of the vaccine was investigated. The two vaccines were stored at (25 ± 2) ℃ for 2, 4, 6 weeks and (37 ± 2) ℃ respectively Under storage for 7, 14 and 21 days, the accelerated stability of the vaccine was investigated. Each time point samples were examined for appearance, polysaccharide content, protein content, pH determination, sterility and free polysaccharide content determination. Results The stability of the conjugate vaccine prepared with TT and BSA as carrier protein all met the requirements of the third edition of Chinese Pharmacopoeia (2010 edition). The contents of free polysaccharide of Ps-TT at different time points were significantly different Lower than Ps-BSA (P <0.05). Conclusion TT as a carrier protein preparation 18C pneumococcal conjugate vaccine stability was significantly better than BSA.