stable crystalline form I agomelatine tablets and their preparation methods are disclosed. Its preparation method: one or more protective agents added to pure water and stirred, the mixture was heated to 35 to 40 C., the solution dissolves them until clear, the solution was cooled to room temperature, the crystalline form I agomelatine added and stirred until homogeneous mixture, the step to obtain a protective agent containing crystalline form I agomelatine then mixed until homogeneous part of a pharmaceutical additives, crystalline form I protecting agent was added again containing agomelatine, they were mixed and pelletized in accordance with the wet method and dried, step obtain particles containing crystalline form I agomelatine in and finally, according to proportion of the other pharmaceutical additives in addition to the particles, then mixed until they uniform, including those the step of tabletingBACKGROUND安定な結晶I形アゴメラチン錠剤およびその調製方法が開示される。その調製方法は:1種または複数の保護剤を純水中に加え、撹拌し、混合物を35~40℃に加熱し、溶液が透明になるまでそれらを溶解し、溶液を室温に冷却し、結晶I形アゴメラチンを加え、混合物を均一になるまで撹拌して、結晶I形アゴメラチンを含有する保護剤を得るステップ;次いで、医薬用添加剤の一部を均一になるまで混合し、結晶I形アゴメラチンを含有する保護剤を再び加え、それらを湿式法に従って混合およびペレット化し、乾燥して、結晶I形アゴメラチンを含有する粒子を得るステップ;および最後に、他の医薬用添加剤をある割合に従って粒子中に加え、それらを均一になるまで混合し、それらを打錠するステップを含む。【選択図】なし
