人免疫球蛋白白喉抗体国家标准品的协作标定

The calibration of the national standard for diphtheria antibody human immunoglobulin

目的协作标定人免疫球蛋白白喉抗体国家标准品。方法用世界卫生组织提供的白喉抗毒素国际标准品(批号:9897/762)为标准,采用被动血凝法标定我国人免疫球蛋白白喉抗体国家标准品,将待标品按标示量加水溶解后,置于4℃保存6个月和将冻干待标品分别置于4,25,37℃保存6个月,进行稳定性考查。结果人免疫球蛋白白喉抗体国家标准品的效价为0.4 HAU/支,稳定性好,其他项目符合国家标准品要求。结论该批冻干人免疫球蛋白白喉抗体国家标准品可取代上批国家标准品。

Purpose The aim is to calibrate the national standard for diphtheria antibody human immunoglobulin by the collaborative study to replace the previous national standard, Methods The potencies of the national standard for diphtheria antibody were assayed against the international standard for diphtheria antitoxin equine（lot ：9897/762）by passive hemagglutination method. The reconstituted solutions of diphtheria antibody national standard were stored at 4 ℃ for 6 months and the freeze-dry national standard for diphtheria antibody was stored at 4,25,37 ℃ for 6 months for stability studies, Results The potency of diphtheria antibody is 0,4 HAU/ampoule, The results of stability studies showed that the preparation was very stable. All the other items met the requirements for national standard of China. Conclusion The national standard for diphtheria antibody human immunoglobulin can replace the previous national standard.