The invention discloses the method for lyophilized preparation of preparation factors IX, such prepared product kept surpass 90% factors IX calcium in conjunction with character.With respect to the factors IX of trehalose of no use preparation, after storing for 12 weeks 25 ℃/60% relative humidity (RH) and 40 ℃/75%RH under, demonstrate the stability distribution of excellence with the factors IX of trehalose preparation.These data show, comprise temperature drift or even long room temperature storage that trehalose can allow the factors IX freeze-drying prods in preparation.The preparation of being tested contains 10mM histidine pH 6.8,3% mannitol, 66mM sodium chloride, 0.0075% polysorbate80, contains and do not contain 1% trehalose.Storing under 40 ℃/75%RH or the 25 ℃/60%RH above after 12 weeks, the preparation that contains trehalose is suitable with the products that store down at 2~8 ℃, and finds that the preparation that does not contain trehalose has produced significant gathering and loss of activity.These two kinds of preparations have confirmed to store the similar stability that surpassed for 26 weeks down in real time at-20 ℃ and 2~8 ℃.
