首批人凝血因子Ⅱ和Ⅹ浓制剂国家标准品协作标定  

The calibration of the first batch of national standard for factor Ⅱ and Ⅹ concentrate

作　　者：沈琦[1] 任跃明[1] 刘大英[1] 曹勤立 Elaine Gray 李胜彩[4] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中美合资上海莱士血制品有限公司,上海200246 [3]英国国家生物标准检定所 [4]上海生物制品研究所,上海200052

出　　处：《中国生化药物杂志》2002年第4期166-168,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的协作标定首批人凝血因子Ⅱ和Ⅹ浓制剂国家标准品。方法用世界卫生组织 98 590批人凝血因子Ⅱ和Ⅹ浓制剂国际标准品 ,采用一期法标定我国首批人凝血因子Ⅱ和Ⅹ浓制剂国家标准品 ,将标准品分别于4℃、2 2℃、37℃保存 5个月 ,进行稳定性考查。结果人凝血因子Ⅱ和Ⅹ国家标准品的效价分别为 1 6 .1IU 支和 1 2 .1IU 支 ,稳定性良好。PurposeTo calibrate the first batch of national standard for human coagulation factor Ⅱ(FⅡ) and Ⅹ(FⅩ) concentrate by collaborative study.MethodsThe potencies of the national standard for FⅡ and FⅩ concentrate were assayed against 98/590 international standard by one stage clotting method. Ampoules of FⅡ and FⅩ national standards were stored at 4℃、22℃、37℃ for 5 months for accelerated degradation studies.ResultsThe results showed that the natinal standards were very stable. The potencies of the national standards for FⅡ and FⅩ concentrate were 16.1 IU/ampoule and 12.1 IU/ampoule respectively and the quality met the requirements for national standard of China.ConclusionThe first batch of national standard for human coagulation FⅡ and FⅩ concentrate was established.

关 键 词：人凝血因子Ⅱ 人凝血因子Ⅹ 人凝血酶原复合物浓缩物 标准品 

分 类 号：R973[医药卫生—药品]