PROBLEM TO BE SOLVED: To provide a method for producing a pharmaceutical preparation comprising, as an active ingredient, bortezomib which is stable and excellent in re-solubility.SOLUTION: There is provided a method for producing a pharmaceutical preparation comprising, as an active ingredient, bortezomib, which comprises: (step 1) a step of dissolving bortezomib or a pharmaceutically acceptable salt thereof, or a derivative of bortezomib in an aqueous solvent having a pH of 8.0 to 14.0 to prepare a solution (step 2) a step of adjusting the solution to a pH of 3.0 to 6.5 and (step 3) a step of removing the aqueous solvent.SELECTED DRAWING: NoneCOPYRIGHT: (C)2018,JPO&INPIT【課題】安定で再溶解性に優れたボルテゾミブを有効成分とする医薬製剤の製造方法を提供することが課題となっている。【解決手段】(工程1)ボルテゾミブ又はその医薬的に許容される塩、若しくはボルテゾミブの誘導体を、pH8.0~14.0の水系溶剤に溶解して、溶液を調製する工程、(工程2)前記溶液を、pH3.0~6.5に調整する工程、(工程3)水系溶剤を除去する工程、を含むボルテゾミブを有効成分とする医薬製剤の製造方法。【選択図】なし
