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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 investigate the stability of immune complex type hepatitis B vaccine. Methods The compound type hepatitis B vaccine was stored at 37 ℃ for 6 weeks (accelerated stability test) and stored at 2-8 ℃ for 30 months (long-term stability test), and the quality indexes were tested and compared Differences in Mouse Efficacy (ED50) vs Conventional Recombinant Hepatitis B Vaccine (Yeast). Results After being preserved at 37 ℃ for 6 weeks and stored at 2 ~ 8 ℃ for 30 months, all the quality indexes of the immunocomplex-type hepatitis B vaccine conformed to the quality standard of its provisional protocol. The ED50 value of mice at different times The detection results were lower than those of conventional hepatitis B vaccine, and the increasing trend was slower than that of conventional hepatitis B vaccine. The differences were statistically significant except for those preserved at 37 ℃ for 2 weeks and 4 weeks (P <0.05). Conclusion The immunocomplex-type hepatitis B vaccine has good stability and its ED50 value is better than that of conventional hepatitis B vaccine and has better stability than the conventional hepatitis B vaccine. This study provides experimental evidence for determining the duration of the immune complex-boosting hepatitis B vaccine.