CAJ | 학술논문

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。
우화격활보체시험적조건，완선정주인면역구단백Fc단생물학활성적검측방법。방법채용보체활화경전도경적원리，분별탐토치민홍세포밀도화저존시간대인면역구단백 Fc단생물학활성검측결과적영향；비교수공법화미공판분광광도법검측Fc단생물학활성적검측결과。결과재치민홍세포A541 nm＝1．3화치민홍세포저존5 d시，검측결과교은정。미공판분광광도법검측우우수공법。결론완선료인면역구단백Fc단생물학활성적검측방법，검측결과준학、중복성호。
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 :A54 1 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 .