静注人免疫球蛋白中白喉抗体效价对其Fc段生物学活性检测结果影响的分析

目的分析静注人免疫球蛋白(IVIG)中白喉抗体效价对其Fc段生物学活性检测的影响。方法检测20批IVIG的白喉抗体效价水平和Fc段生物学活性结果,进一步探讨白喉抗体效价与Fc段生物学活性的关系。结果20批IVIG中白喉抗体效价水平均符合中国药典的要求,在3~60 HAU/g之间,其中有两批IVIG的白喉抗体效价水平相对较高,其他18批IVIG的白喉抗体效价水平变化趋势不明显。20批IVIG的Fc段生物学活性均较高,在60%~140%之间。白喉抗体效价水平高者,其Fc段生物学活性并非高,反之亦然。结论 IVIG的Fc段生物学活性与其白喉抗体效价水平无明显的相关性。

Analysis on effect from titre of diphtheria antibody containing in IVIG in detecting for biological properties of Fc fragment of IVIG

Objective To analyze the effect from titre of diphtheria antibody containing in IVIG （ Human immuglobulin （pH4.0） for intravenous injection） in detecting for biological properties of Fc fragment of IVIG. Methods The titre of diphtheria antibody and the biological properties of Fc fragment from 20 batches of IVIG were analyzed, and investigation was carried out on the relationship between titre of diphtheria antibody and biological properties of Fc fragment. Results Diphtheria antibody titre from 20 batches of IVIGis in a range 3 to 60 HAU/g, based on related requirements, diphtheria antibody titre in 2 batches of IVIG is greater than that of other batches. Biological properties of Fc fragment is in a higher range between 60% and 140%. Conclusion Biological properties of Fc fragment is not correlated with titre of diphtheria antibody containimg in IVIG.