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目的制备首批肠道病毒71型免疫球蛋白国家标准品,用于肠道病毒71型特异性免疫球蛋白产品效价测定。方法选择国内经批签发检验合格的静注人免疫球蛋白产品以及高效价肠道病毒71型人免疫球蛋白作为原料进行合并,分装冻干后并按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。在5家实验室按微量细胞病变法进行协作标定,以肠道病毒71型中和抗体滴度的倒数作为中和效价,单位定义为u。结果 5家实验室共进行了63次协作标定,结果均经LOG转换后进行计算,实验室内几何变异系数GCV范围为1.5%~4.1%,实验室间几何变异系数GCV平均值为3.1%,效价几何平均值为327 U。为以后使用和计算方便,该批次标准品赋值为330 U。该标准品160 d加速破坏实验和22 m长期稳定性考察显示效价稳定无下降趋势,12 m测定不同温度点的单体加二聚体(HPLC-SEC法)含量大于98.0%,有效成分稳定。该标准品的水分含量为0.6%,分装精度为0.56%,无菌检查合格。结论该批肠道病毒71型人免疫球蛋白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肠道病毒71型特异性免疫球蛋白的效价测定。
Objective To prepare the first national standard of enterovirus 71 immunoglobulin for the determination of enterotoxigenic 71 immunoglobulin titer. Methods The domestic batch of approved intravenous immunoglobulin products and the high-titer enterovirus 71 human immunoglobulin were selected as the raw materials for the batch merger. After the samples were lyophilized and the moisture content of the standard samples was dispensed Accuracy, aseptic inspection and stability inspection. Collaborative calibration was performed in five laboratories according to the microcytopathogenic assay. The reciprocal of the titer of the enterovirus 71 neutralizing antibody was used as the neutralizing titer, and the unit was defined as u. Results Collaborative calibration was carried out in 5 laboratories for 63 times. The results were calculated after LOG conversion. The geometric variation coefficient (GCV) ranged from 1.5% to 4.1% in laboratory, and the mean value of GCV was 3.1% The geometric mean of the titer is 327 U. For future use and calculation convenience, the batch standard value is 330 U. The 160 d accelerated destruction test and the 22 m long-term stability test showed that the titer of the standard was stable without any decrease. The content of monomer-dimer (HPLC-SEC) at different temperature points at 12 m was more than 98.0%, and the active ingredient was stable . The standard moisture content of 0.6%, packaging accuracy of 0.56%, sterile check. Conclusion The results showed that all the test items of this group of enterovirus 71 human immunoglobulin standards met the requirements and could be used as the national standard for the determination of the titer of enterovirus 71-specific immunoglobulin.