摘要 |
本发明揭示用于测定去纤维蛋白多核苷酸之生物活性的方法,其包括以下步骤:a)使哺乳动物的优球蛋白及对血纤维蛋白溶酶具特异性的基质接触去纤维蛋白多核苷酸,该基质藉由与该血纤维蛋白溶酶作用而提供一可测量的产物;以及b)测量于连续时间中所产生的产物之量,藉以测定该去纤维蛋白多核苷酸的生物活性。本发明亦揭示液体去纤维蛋白多核苷酸配方,其较佳为水溶液,具有定义的生物活性,且特别系具有去纤维蛋白多核苷酸之活性为25至35IU/mg者,较佳为27.5至32.5IU/mg,以及更佳为28至32IU/mg。; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg. |