The present invention is directed to a lyophilized preparation which contains a synthetic quinolone antibacterial compound and, as a solo additive, a pH-adjusting agent, and which exhibits an excellent reconstituting property. The invention provides a method for producing a lyophilized preparation containing a synthetic quinolone antibacterial compound as an active ingredient, characterized by including, sequentially, cooling an aqueous solution containing a synthetic quinolone antibacterial compound and a pH-adjusting agent to yield a frozen product, elevating the temperature of the frozen product, and re-cooling the resultant to prepare the lyophilized preparation.
本发明涉及一种冻干制剂,其包含合成喹诺
酮类抗菌化合物和一个pH调节剂作为单一添加剂,并表现出优异的重构性能。本发明提供了一种制备含有合成喹诺
酮类抗菌化合物作为活性成分的冻干制剂的方法,其特征在于依次包括将含有合成喹诺
酮类抗菌化合物和pH调节剂的
水溶液冷却以产生冻结产物,提高冻结产物的温度,然后再次冷却以制备冻干制剂。