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    약제학적 조성물 및 이의 제조방법
    1.
    发明公开
    약제학적 조성물 및 이의 제조방법 审中-实审
    药物组合物及其制备方法

    公开(公告)号：KR1020130109425A

    公开(公告)日：2013-10-08

    申请号：KR1020120031154

    申请日：2012-03-27

    Applicant: 일양약품주식회사

    Inventor： 김동연 ,  신재수 ,  임현태 ,  김대성 ,  이승현 ,  성준호

    IPC: A61K31/505 ,  A61K31/417 ,  A61K9/16 ,  A61K9/20

    CPC classification number: A61K31/506 ,  A61K9/2009 ,  A61K9/485

    Abstract: PURPOSE: A pharmaceutical composition is provided to reduce electrostatic characteristics and adsorption with safety and to improve elution rate and bioavailability. CONSTITUTION: A pharmaceutical composition contains 20-1000 mg of 4-methyl-N-[3-(4-methylimidazole-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyrazine-2-yl-pyrimidine-2-ylamino)-benzamide hydrochloride as an active ingredient and a pharmaceutically acceptable excipient. The pharmaceutical composition is manufactured in the form of a granule, a powder, a tablet, a capsule, or a suspension. A method for manufacturing the pharmaceutical composition comprises the steps of wet/dry-granulating the active ingredient using a solvent or aqueous/oil cosolvent of a surfactant and/or an organic solvent as a solubilizing agent. [Reference numerals] (AA) Dissolution rate (%); (BB) Example 2; (CC) Example 3; (DD) Example 4; (EE) Comparative example 1; (FF) Comparative example 2; (GG) Comparative example 3; (HH) Comparative example 4

    Abstract translation: 目的：提供一种药物组合物，以安全降低静电特性和吸附，并提高洗脱速率和生物利用度。 组成：药物组合物含有20-1000mg的4-甲基-N- [3-（4-甲基咪唑-1-基）-5-三氟甲基 - 苯基] -3-（4-吡嗪-2-基 - 嘧啶-2-基） 吡啶-2-基氨基） - 苯甲酰胺盐酸盐作为活性成分和药学上可接受的赋形剂。 药物组合物以颗粒，粉末，片剂，胶囊或悬浮液的形式制造。 制备药物组合物的方法包括使用表面活性剂和/或有机溶剂的溶剂或水/油共溶剂作为增溶剂湿/干造粒活性成分的步骤。 （AA）溶解速度（％） （BB）实施例2; （CC）实施例3; （DD）实施例4 （EE）比较例1; （FF）比较例2; （GG）比较例3; （HH）比较例4

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