免疫复合物型增效乙型肝炎疫苗的稳定性

Stability of immune complex as enhanced hepatitis B vaccine

目的探讨免疫复合物型增效乙型肝炎疫苗的稳定性。方法将复合物型增效乙型肝炎疫苗分别于37℃保存6周(加速稳定性试验),2～8℃保存30个月(长期稳定性试验),进行各项质量指标检测,并比较其小鼠效力(ED50值)与常规重组乙型肝炎疫苗(酵母)的差异。结果经37℃保存6周,2～8℃保存30个月后,免疫复合物型增效乙型肝炎疫苗各项质量指标均符合其暂定规程质量标准;小鼠效力(ED50值)不同时间点检测结果均低于常规乙肝疫苗,且升高趋势慢于常规乙肝疫苗,除37℃保存2周和4周外,其余差异均具有统计学意义(P<0.05)。结论免疫复合物型增效乙型肝炎疫苗稳定性良好;其小鼠效力(ED50值)优于常规乙肝疫苗,且比常规乙肝疫苗具有更好的稳定性。本研究为确定免疫复合物型增效乙型肝炎疫苗的有效期提供了实验依据。

Objective To study the stability of immune complex as enhanced hepatitis B （HB） vaccine. Methods Immune complex as enhanced HB vaccine was stored at 37℃ for 6 weeks （accelerated stability test） and at 2-8℃ for 30 months （long term stability test） respectively, and subjected to overall control tests, of which the potency （EDs0） in mice was compared with that of routine recombinant HB （yeast） vaccine. Results All the quality indexes of immune complex as enhanced HB vaccine after storage at 37℃ for 6 weeks and at 2 ~ 8℃ for 30 months met the relevant temporary requirements. Compared with those of routine HB vaccine, the ED^0 values of the immune complex in mice at various time points were low, of which the increasing rate was slow. The DE50 values of immune complex, except those after storage at 37℃ for 2 and 4 weeks, showed significant difference from those of routine HB vaccine （P 〈 0. 05）. Conclusion Immune complex as enhanced HB （HB） vaccine showed high stability as compared with routine HB vaccine, of which the potency in mice was superior to that of routine HB vaccine. It provided an experimental basis for determination of validity period of immune complex as enhanced HB vaccine.