PROBLEM TO BE SOLVED: To provide an RTU (Ready-to-use) pharmaceutical preparation of a highly convenient solution form that is required in a medical field, does not require a complex dissolution process comparing to lyophilized pharmaceutical preparation, and can be quickly administered after dilution.SOLUTION: A method for producing a medicine solution pharmaceutical preparation in which oxygen content is reduced and sealed, including: (a) a process 1 of preparing medicinal solution containing active ingredient (b) a process 2 of injecting the medicinal solution into a sealable container (c) a process 3 of bringing the medicinal solution to 20°C or lower (d) a process 4 of decompressing the medicinal solution to pressure which is higher than the vapor pressure of solvent of the medicinal solution and lower than the atmospheric pressure (e) a process 5 of recovering the pressure by inert gas that essentially does not contain oxygen (f) a process 6 of leaving the medicinal solution to stand in the inert gas atmosphere at the temperature of a coagulation point of medicinal solution or higher and (g) a process 7 of sealing a container filled with medicinal solution under the inert gas atmosphere that essentially does not contain oxygen.SELECTED DRAWING: NoneCOPYRIGHT: (C)2019,JPO&INPIT【課題】 医用現場において、凍結乾燥製剤より、煩雑な溶解工程が不要で希釈してすぐ投与できる等で利便性が高い溶液形態のRTU(Ready-to-use)製剤が求められている。【解決手段】酸素含有率が低減して封止された医薬品溶液製剤の製造方法であって、(a)有効成分を含む薬液を調製する工程1、(b)前記薬液を封止可能な容器に注入する工程2、(c)前記薬液を20℃以下にする工程3、(d)前記薬液を当該薬液の溶媒の蒸気圧より高く、且つ大気圧より低い気圧に減圧する工程4、(e)酸素を実質的に含まない不活性ガスで気圧を回復させる工程5、(f)前記薬液を、薬液の凝固点以上の温度で前記不活性ガス雰囲気において静置する工程6、(g)酸素を実質的に含まない不活性ガス雰囲気の下、薬液入り容器を封止する工程7、による、医薬品溶液製剤の製造方法。【選択図】なし
