PROBLEM TO BE SOLVED: To provide a sustained-release solid formulation which is not affected by ion strength, pH, and compressive force during molding, and capable of controlling the elution of active ingredients which are small in water solubility to zero order elution etc.SOLUTION: This sustained-release solid formulation contains at least an active ingredient and an elution controlling base, and the active ingredient has solubility in water of 0.0001-100 mg/cm3, and the elution controlling base is modified starch, having a water retaining capacity of not smaller than 400%, gel push-in load value of not lower than 200 g, water solubles content of 40-95 wt.%, and the passing particles through 75 &mum sieve mesh of not smaller than 90 wt.%, the passing particles through 32 &mum sieve mesh of not smaller than 20 wt.%, an average particle diameter of not smaller than 20 &mum but smaller than 50 &mum, and contains a hydrophilic auxiliary agent having solubility to water of 0.1-5.0 g/cm3 at 20°C, and a molecular weight of not greater than 1,000, and the compounding ratio of the modified starch to the hydrophilic auxiliary agent is 5:40-99:1.COPYRIGHT: (C)2007,JPO&INPIT【課題】 イオン強度やpH、成形時圧縮力に影響を受けず、水への溶解性が小さい活性成分の溶出を0次溶出等に制御できる徐放性固形製剤を提供する。【解決手段】 1種以上の活性成分と溶出制御基剤とを含有する徐放性固形製剤で、活性成分は水への溶解度が0.0001~100mg/cm3であり、溶出制御基剤は保水量400%以上でゲル押込み荷重200g以上で水溶性成分量40~95重量%で目開き75μmの篩いの通過粒子が90重量%以上で目開き32μmの篩いの通過粒子が20重量%以上で平均粒径が20μm以上50μm未満の加工澱粉であり、水への溶解度が20℃で0.1~5.0g/cm3かつ分子量が1000以下の親水性助剤を含有し、加工澱粉と親水性助剤との配合比率が5:40~99:1である。【選択図】 図1
