激活补体试验检测静注人免疫球蛋白Fc段生物学活性的优化

优化激活补体试验的条件,完善静注人免疫球蛋白Fc段生物学活性的检测方法。方法采用补体活化经典途径的原理,分别探讨致敏红细胞密度和贮存时间对人免疫球蛋白Fc段生物学活性检测结果的影响;比较手工法和微孔板分光光度法检测Fc段生物学活性的检测结果。结果在致敏红细胞A541 nm=1.3和致敏红细胞贮存5 d时,检测结果较稳定。微孔板分光光度法检测优于手工法。结论完善了人免疫球蛋白Fc段生物学活性的检测方法,检测结果准确、重复性好。

Optimization on activating complement in detecting biological properties of Fc fragment of IVIG

Objective To optimize the conditions of activating complement on Fc fragment of human immunoglobulins （pH4.0）for intravenous injection（IVIG） and improve the detection method for biologic properties of Fc fragment. Meth- ods The density of taned red blood cell and stored time of antigen-coated tanned red blood cell were optimized by activa- ting complement on the classical way, and the difference of Fc function were compared by using manual and microtitre plate method. Results The repeatability of activating complement method may be better in the following conditions：As41 of red blood cells= 1.3 ,stored time for antigen-coated tanned red blood cells 1-5 days . The microtitre plate method is better than manual method. Conclusion The detection of biological properties on Fc fragment of IVIG was successfully improved. The improved method is accurate and repetitive by using microtitre plate.