抗A、抗B血型定型试剂(单克隆抗体)国家参考品的制备与协作标定  

Preparation and collaborative calibration of national reference substances for anti-A and anti-B blood grouping reagents(monoclonal antibodies)

作　　者：马秋平[1] 吕秀华[1] 侯继锋[1] 

机构地区：[1]中国食品药品检定研究院血液制品室,北京100050

出　　处：《药物分析杂志》2012年第12期2270-2273,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:制备并标定抗A、抗B血型定型试剂(单克隆抗体)国家参考品。方法:按2010版年版中国药典三部和2000年版《中国生物制品规程》的有关要求,制备了抗A、抗B血型定型试剂(单克隆抗体),并分装冻干、进行质量检测,复溶后对效价开展协作标定,并进行稳定性检测。结果:抗A、抗B血型定型试剂的装量、外观、复溶时间、特异性、亲和力、效价、冷凝集素和不规则抗体检测、水分测定均符合2000年版《中国生物制品规程》中的规定。不同实验室的标定结果差异较大,计算效价的几何均数,抗A血型定型试剂结果为对A11∶256～1∶512之间,对A21∶128～1∶256之间,对A2B 1∶128～1∶256之间;抗B试剂结果对B 1∶256～1∶512之间。稳定性检测符合要求。结论:该抗A、抗B血型定型试剂各项指标均符合要求,可作为国家参考品使用;经标准物质委员会讨论,将该参考品稀释1倍后可作为抗A、抗B血型定型试剂产品的最低效价标准。Objective：To prepare and calibrate the national reference substances for anti - A and anti - B blood grouping reagents （monoclonal antibodies）. Methods：According to the relevant requirements in Chinese Pharmaco- poeia （2010 Edition） and China Biological Products Standards （2000 Edition） ,anti -A and anti -B blood group- ing reagents （monoclonal antibodies） were prepared and calibrated in a collaborative study after dispersal, lyophili- zation, quality control, and reconstitution. Stability of the reagents was also examined. Results： The mean weight, ap- pearance, reconstitute time, specificity, affinity, titer, cold agglutinin and irregular antibody, and moisture detection of these reagents conformed to the requirements of China Biological Products Standards （2000 Edition）. The calibra- tion results between laboratories showed large difference. The mean titers of anti - A blood grouping reagents were 1 ： 256 - 1：512 to A1 ,1：128 - 1：256 to A2 ,and 1：128 - 1：256 to A2B. The mean titer of anti - B was 1：256 - 1： 512 to B. The stability test results conformed to the requirements. Conclusion：On the basis of these results, the anti - A and anti - B blood grouping reagents （ monoclonal antibodies） could be used as national reference substances. The standard materials committee the reference substances （dilute 1 in 2 ） could be used as minimum potencies standards of anti - A and anti - B blood grouping reagents.

关 键 词：ABO血型系统 血型定型试剂 单克隆抗体 参考品 效价 协作标定 

分 类 号：R917[医药卫生—药物分析学]