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    • 8. 发明公开
    • 클로피도그렐 및 아스피린의 복합제제
    • 龙胆和阿司匹林的组合
    • KR1020130048335A
    • 2013-05-10
    • KR1020110113131
    • 2011-11-02
    • 한국유나이티드제약 주식회사
    • 정원태최연웅남규열박상만하대철도남혁이성능신경도
    • A61K9/48A61K9/16A61K31/4743A61K31/616A61K31/4365
    • A61K31/4365A61K9/5084A61K31/616A61K9/48A61K9/167A61K31/4743A61K2300/00
    • PURPOSE: A composite formulation of clopidogrel and aspirin is provided to basically block an eutectic symptom by blocking the physical contact of aspirin with clopidogrel, to prevent change of bioequivalence, to enhance formulation stability, and to prevent stomach damage by coating aspirin. CONSTITUTION: A composite formulation contains a clopidogrel granule, an aspirin granule, and a capsule containing the granules. The clopidogrel granules comprises: an inner core containing excipient; a clopidogrel outer core which is adjacent to the outside of the inner core and contains clopidogrel, an isomer thereof or a pharmaceutically acceptable salt thereof, and a first binder; and an immediate release protective layer which is adjacent to the outside of the outer core and contains a second binder and a first plasticizer. The aspirin granule comprises: an inner core containing excipient; an aspirin outer core which is adjacent to the inner core and contains aspirin, a pharmaceutically acceptable salt thereof, and a third binder; and an enteric coating layer which is adjacent to the outside of the outer core and contains an enteric coating agent and a second plasticizer. [Reference numerals] (AA,DD) Inner core; (BB) Clopidogrel; (CC) Immediate release protective layer; (EE) Aspirin; (FF) Enteric coating layer
    • 目的:提供氯吡格雷和阿司匹林的复合制剂,通过阻断阿司匹林与氯吡格雷的物理接触,以防止生物等效性的变化,提高制剂的稳定性,并通过涂布阿司匹林来防止胃部损伤,从而基本阻断共晶症状。 构成:复合制剂含有氯吡格雷颗粒,阿司匹林颗粒和含有颗粒的胶囊。 氯吡格雷颗粒包含:含有内核的赋形剂; 氯吡格雷外芯,其与内核的外部相邻并含有氯吡格雷,其异构体或其药学上可接受的盐和第一粘合剂; 以及与所述外芯的外部相邻并且包含第二粘合剂和第一增塑剂的立即释放保护层。 阿司匹林颗粒包含:含有内核的赋形剂; 阿司匹林外芯,其与内芯相邻并含有阿司匹林,其药学上可接受的盐和第三粘合剂; 以及与所述外芯的外侧相邻并且含有肠溶衣剂和第二增塑剂的肠溶衣层。 (标号)(AA,DD)内芯; (BB)氯吡格雷; (CC)即时释放保护层; (EE)阿司匹林; (FF)肠溶衣层