微量法测定人免疫球蛋白制剂Fc段生物学活性  

Micro-determination on activating complement in detecting biological properties of Fc fragment of IVIG

作　　者：陆婷婷 章俊 孙玉忠 周顺波 王蕴红 丁亚凌 LU Tingting;ZHANG Jun;SUN Yuzhong;ZHOU Shunbo;WANG Yunhong;DING Yaling(Chengdu Rongsheng Pharmaceuticals Co.,LTD,ChengDu 610041,China)

机构地区：[1]成都蓉生药业有限责任公司,四川成都610041

出　　处：《中国输血杂志》2021年第7期713-715,共3页Chinese Journal of Blood Transfusion

摘　　要：目的通过改良《中国药典》收录的人免疫球蛋白Fc段生物学活性测定法,建立1种适用于酶标仪的高效检测方法。方法本文对《中国药典》收录(通则3514)的人免疫球蛋白FC段生物学活性测定方法,在敏化过程、样品处理及动力曲线参数上进行了调整,并同时采用Origin软件对溶血反应动力学曲线进行了拟合计算结果,使检测方法更适合于采用酶标板检测,通过对比标准品和供试品溶血反应动力学曲线计算人免疫球蛋白Fc段功能活性。结果本方法检测结果稳定,重复性和中间精密度RSD约为10%。检测效率大幅提升,采用96孔酶标板,最高可同时进行30批样品检测(较药典紫外分光光度法)。结论本方法测定人免疫球蛋白制剂Fc段功能活性的稳定性好,检测效率高,可用于人免疫球蛋白制剂中Fc段功能活性检测。Objective To improve method for determinating of biological potency of IgG Fc fragment in Chinese Pharmacopoeia and establish a method which is suitable for enzyme-labeled instrument.Methods The biological properties of FC fragment of IVIG in Chinese Pharmacopiea(General 3514)was adjusted,including sensitization process,sample treatment and dynamic curve parameters.Meanwhile,the kinetic curve of hemolysis was fitted with Origin,which made the method more suitable for enzyme plate.The biological properties of Fc fragment of IVIG was calculated by kinetics curve reaction of reference and sample.Results The method are stable,the RSD of repeatability and intermediate is 10%,also with significant improvement in efficiency.Conclusion The detection of properties of Fc fragment of IVIG is stable and efficient,it can be used for properties of Fc fragment of IVIG.

关 键 词：Fc段功能活性 人免疫球蛋白 IGG 

分 类 号：R457.1[医药卫生—治疗学] Q512.2[医药卫生—临床医学]