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目的:制备重组肠道病毒71型(enterovirus 71，EV71)疫苗(汉逊酵母)抗原冻干参考品，用于重组EV71疫苗(汉逊酵母)的抗原含量测定。方法:选取检定合格的重组EV71疫苗(汉逊酵母)原液，加入冻干保护剂，冷冻干燥制备重组EV71疫苗(汉逊酵母)抗原冻干参考品，对其进行保护剂抗原含量标定，并对其进行反复冻融试验，37 ℃、2～8 ℃和-20 ℃稳定性研究。结果:制备的抗原冻干参考品鉴别试验、无菌检查结果均符合规定，水分含量为1.4%。经标定，抗原含量的几何均值为2 146 U/ml，几何变异系数为7.2%。10次反复冻融，抗原含量仍无明显变化；37 ℃放置3个月，抗原含量无明显变化；分别于2～8 ℃和-20 ℃放置30个月，抗原含量仍较为稳定。结论:制备了一批稳定的、均一性良好的抗原冻干参考品，可以用于重组EV71型疫苗(汉逊酵母)抗原含量测定。“,”Objective:To prepare a lyophilized reference antigen of recombinant enterovirus 71 (EV71) vaccine (n Hansenula) for the determination of antigen content of recombinant EV71 vaccine (n Hansenula).n Methods:Bulk of qualified recombinant EV71 vaccine (n Hansenula) was selected as the raw material of reference, adding freeze-dried protective agent, then lyophilized to prepared freeze-dried recombinant EV71 (n Hansenula)vaccine antigen reference, after the calibration on the antigen content, the reference was carried on the freeze-thaw test, stored at 37 ℃, 2-8 ℃ and -20 ℃for the stability study.n Results:All the quality indexes of prepared reference met the relevant requirements, and the moisture content was 1.4%.After calibration, geometry mean of reference antigen content was 2 146 U/ml and geometric variation coefficient was 7.2%.There was no significant change in antigen content after repeated freezing and thawing for 10 times.There was no significant change in antigen content for 3 months at 37 ℃.The antigen content remained stable at 2-8 ℃ and -20 ℃ for 30 months, respectively.Conclusion:A batch of stable and homogeneous reference antigens were prepared, which could be applied for the determination of antigen content in recombinant EV71 vaccine (n Hansenula).n