国产静注人免疫球蛋白制品Fc段生物学活性分析

The evaluation of Fc function of human immunoglobulin for intravenous injection in Chinese market

目的研究9家中国血液制品企业共计41批次的静脉注射人免疫球蛋白[human immunoglobulin for intravenous injection,IVIG(p H4.0)]制品中Ig G Fc段生物学活性水平。方法基于《中国药典》和《欧洲药典》推荐的IVIG Fc段生物学活性检测方法,自行建立适合本实验室的IVIG Fc段生物学活性检测方法,并利用已建立的方法测定上述样本中Fc段生物学活性。结果 9个厂家IVIG制品中均能检测到针对白喉类毒素抗原的Ig G Fc段生物学活性,且所有样品Fc段生物学活性均高于60%;但每个厂家样品活性各不相同,与厂家A相比,厂家F*>H*>G*>A>C>I>D*>E*>B*(*表示P<0.01,差异显著)。结论所调查的41个批次IVIG制品Fc段生物学活性较高,符合《欧洲药典》检定和限度要求。本研究对国内IVIG制品的有效性做出了评估,为完善制品质量标准提供了理论依据。

Objective To investigate the Fc function of 41 batches of intravenous immunoglobulin （ pH4, hereinafter referred to as IVIG） products from nine blood products manufacturers in China. Methods Based on the methods which were recommended by the Chinese Pharmacopoeia and European Pharmacopoeia, appropriate methods were established to detect IVIG Fc function. Results The Fc function of all the samples was higher than 60%, but each of the Fc function was different from manufacturer A to manufacturer H. Comparing with the Fc function of manufacturer A, the functions of all manufacturers were summarized as followed： F＊ 〉 H＊ 〉 G＊ 〉 A〉 C〉 I〉 D＊ 〉 E＊ 〉 B＊（ ＊ indicatesP〈0.01, significant difference）. Conclusion The Fc function of 41 batches of IVIG samples meets the requirements of the European Pharmacopoeia. Our study will provide a theoretical basis for improving the quality standards of IVIG samples.