抗-HBs国家标准品的研制

Calibration of the 1^(st) national standard for anti-hepatitis B surface antigen

目的:协作标定首批冻干抗-HBs 国家标准品。方法:以首批抗-HBs 国际标准品(17—2—77批号)为标准,采用放射免疫法标定我国抗-HBs 国家标准品。结果:国家标准品(人免疫球蛋白)的效价为2.5 IU·支^(-1),抗-HBs 国家标准品(人血浆)的效价为1.3 IU·支^(-1)。将以上标准品按标示量加水溶解后于4℃放置9 d 和将冻干标准品分别置于4,23,45℃保存6个月,进行稳定性考察。研制的首批冻干抗-HBs 国家标准品稳定性良好,其他项目符合国家标准品要求。结论:已制备首批抗-HBs 国家标准品,并获得国家标准品批准文号。

Objective：To calibrate the 1^st national standard for anti -hepatitis B surface antigen （anti -HBs） by the collaborative study. Method：The potencies of the national standard for were assayed against 15, international standard for anti - hepatitis B immunoglobulin （lot ： 17 - 2 - 77） by RIA method. The reconstituted solutions of anti -HBs national standards were stored at 4 ℃ for 9 days and the freeze -dry standards were stored at 4,23,45 ℃ for 6 months for stability studies. Results： The potency of anti - HBs （ human immunoglobulin） was 2.5 IU · per ampoule^-1 ;The potency of anti - HBs （human plasma） was 1.3 IU perampoule^-l. The results of stability studies showed that the preparation was very stable. The all other items met the requirements for national standard of China. Conclusion：The 1^st national standard for anti -HBs are established and are authorized.