PROBLEM TO BE SOLVED: To provide a method for producing a granulated product that masks a physiologically active substance having a bitter taste, improves administration property for a patient, has stability against light and controls dissolution property, through a simple process with high productivity.SOLUTION: A method for producing minute particles (fine granule) comprises: charging a spouted fluid-bed granulating device with additive powder particles having a high liquid retaining ability adding by spraying a liquid, which is prepared by dispersing, suspending or partially dissolving a physiologically active drug in water, an aqueous solution of a water-soluble polymer, a dispersion liquid of a water-insoluble substance or a mixture liquid of these, to prepare a granulated product, while maintaining a fluidized condition in the device and coating the granulated product with a water-soluble polymer, sugar or sugar alcohol, a water-insoluble substance, or a mixture of these to ensure stability against light and to mask a bitter taste. By compounding the obtained minute particles with other additives, a solid preparation with high qualities and superior administrating property can be produced.COPYRIGHT: (C)2014,JPO&INPIT【課題】苦味を有する生理活性物質をマスキングし患者の服用性の改善や光安定性、さらに溶出制御された造粒物を、簡便かつ生産性の高い方法で製造する方法の提供。【解決手段】液保持能力の高い添加剤粉末粒子を噴流流動層造粒装置に仕込み、流動状態を保ちながら、生理活性薬物を水、水溶性高分子の水溶液又は水不溶性物質の分散液もしくはこれらの混合液に、分散・懸濁・一部溶解した液をスプレー添加することで造粒物を調製した後、水溶性高分子、糖又は糖アルコール、水不溶性物質もしくはこれらの混合物を被覆することで、光安定性を担保し苦味マスクされた微小粒子(細粒)を製造する方法。さらに、得られた微小粒子を、他の添加剤と配合することにより、服用性に優れた高品質の固形製剤を製造することができる。【選択図】なし
