人免疫球蛋白甲型肝炎抗体国家标准品的研制

目的：研制人免疫球蛋白甲型肝炎抗体国家标准品，用于人免疫球蛋白产品中甲型肝炎抗体效价测定。方法：制备人免疫球蛋白半成品作为标准品原料，分装冻干后按2015版中国药典规定对标准品的水分含量、分装精度、无菌检查和稳定性进行考察。以国际标准品97/646为标准，在3家实验室用ELISA法对国家标准品的甲肝抗体效价进行协作标定。结果：该标准品的水分含量为1.4%，分装精度为0.36%，无菌检查合格。3家实验室对标准品甲肝抗体效价进行了22次标定，实验室间测定的RSD为8.2%，效价的加权平均值为每支34.5 IU。37℃ 158 d加速稳定性试验和-20℃ 12个月长期稳定性试验显示该标准品效价稳定无下降趋势。结论：该批人免疫球蛋白甲型肝炎抗体国家标准品各项检测指标符合要求，可以作为国家标准品发放用于人免疫球蛋白甲型肝炎抗体的效价测定。

Objective:To prepare the national standard for anti-hepatitis A immunoglobulin,which can be used for calibrating the potency of anti-hepatitis A in immunoglobulin.Methods:After dispersal and lyophilizing of semi-finished human immunoglobulin,the moisture,dispersal precision,sterility and stability of the sample were tested conforming to the requirements of ChP 2015.The international standards 97/646 were distributed to three laboratories for cooperative calibration by enzyme-linked immunosorbent assay(ELISA).Results:The standard was qualified in the sterility test,and the moisture content and precision for filling were 1.4% and 0.36%,respectively.A total of 22 calibration tests were carried out by the three collaboration laboratories,and the weighted mean was 34.5 IU per ampule(RSD=8.2%).The potency of the prepared standard was stable in 158-day accelerated stability test at 37℃ and 12-month long-term stability test at -20℃.Conclusion:The prepared national standard for anti-hepatitis A immunoglobulin met all the relevant requirements and can be served as the national standard for the potency test of anti-hepatitis A immunoglobulin.

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