重组葡激酶活性测定参考品的研制  

Preparation of Reference for Determining the Activity of Recombinant Staphylokinase

作　　者：张翊[1] 饶春明[1] 王军志[1] 丁锡申[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国生物制品学杂志》1999年第1期52-54,共3页Chinese Journal of Biologicals

摘　　要：按照标准品的要求研制了重组葡激酶活性参考品 ,经检测外观、无菌、水份等各项指标均符合标准品的要求 ,其活性经过 15次标定 ,结果为 (10 10± 191) U/ dose,变异系数为 19%。本品稳定性良好 ,可以作为重组葡激酶活性测定参考品。A reference for determining the activity of recombinant staphylokinase was prepared according to the requirements for standard.All the detection indexes of the reference met the requirements for standard.The result of 15 times of assignment test showed that the activity of the reference was (1010±191) U/does with a variation coefficent of 19%.The reference also showed good stability.

关 键 词：重组葡激酶 参考品 稳定性 

分 类 号：TQ464.8[化学工程—制药化工] TQ460.72[医药卫生—药物分析学]