| 摘要 |
PURPOSE: A pharmaceutical composition of solid granule containing risedronic acid of high content is provided to reduce mixing uniformity of a formulation and to reduce drug side effect. CONSTITUTION: A pharmaceutical composition for treating osteoporosis contains dry granules containing risedronic acid and an outer phase containing vitamin D. The particle size and density of the granules is 30-80 meshes and 0.5-0.9g/mL, respectively. The vitamin D is cholecalciferol concentrate powder form. The composition is a general tablet, coated tablet, multilayer tablet, multi-coated tablet, or capsule. A method for manufacturing the pharmaceutical composition for treating osteoporosis comprises: a step of preparing the dry granules containing risedronic acid, physiologically acceptable salt thereof, or hydride; and a step of mixing the outer phase.
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