目前 ,葡激酶正在申报我国一类新药。由于世界卫生组织未颁布国际准品 ,国外也无这种产品上市。为了统一标准 ,保证产品质量 ,我国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要求 ,其活性经 15次标定 ,结果为 (10 10± 191)Ｕ Currently, staphylokinase is declaring a new class of drugs in our country. Since WHO has not promulgated the international standard goods, there is no such product listed abroad. In order to unify the standards and ensure the quality of products, our country has developed a reference product of recombinant staphylokinase according to the requirements of standard products. After testing the appearance, aseptic, water and other indicators are in line with the standard requirements, Is (10 10 ± 191) U