| 摘要 |
PURPOSE: A method for manufacturing a stable pharmaceutical composition containing eperisone or a pharmaceutically acceptable salt thereof is provided to suppress generation of related compounds from eperisone, and to maintain the content of an active ingredient through dry-granulation without a solvent. CONSTITUTION: A method for manufacturing a pharmaceutical composition comprises the steps of: mixing eperisone or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient in a blender without a solvent; and dry-granulating the mixture by compression molding and crush-granulating. Eperisone or the pharmaceutically acceptable salt is eperisone hydrochloride. The pharmaceutical composition contains 10-70 wt% of eperisone or the pharmaceutically acceptable salt. The pharmaceutically acceptable excipient is a combination of a dispersing agent, a disintegrant, and a binder. The dispersing agent is selected from the group consisting of lactose, microcrystalline cellulose, mannitol, and a mixture thereof. [Reference numerals] (AA) Severe condition-1; (BB,GG) Related compound 1; (CC,HH) Example 1; (DD,II) Comparative example 1; (EE,JJ) Comparative example 2; (FF) Severe condition-2
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