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一种达比加群酯药物组合物及其制备方法
基本信息:
摘要：
本发明涉及一种达比加群酯药物组合物及其制备方法。本发明的达比加群酯药物组合物包含丸I和丸II：所述丸I含活性成分与空白丸芯材料、粘合剂、抗粘剂和/或隔离材料；所述活性成分为达比加群酯或其药学上可接受的盐、水合物或溶剂合物；所述丸II含药用有机酸与丸芯材料、粘合剂、抗粘剂和/或隔离材料。本发明惊喜的发现将活性成分和有机酸分别包含在不同的两个丸中，既满足了活性成分溶出要求且更均匀，又增强了活性成分与有机酸的隔离效果，从而提高了制剂的稳定性。
摘要（英）：

The invention relates to a dabigatran etexilate medicine composition and a preparation method thereof. The dabigatran etexilate medicine composition consists of a pill I and a pill II, wherein the pill I contains an active ingredient, a blank pill core material, an adhesive, an anti-sticking agent and/or an isolation material, wherein the active ingredient is dabigatran etexilate or a pharmaceutically acceptable salt, hydrate or solvate thereof; and the pill II contains a medicinal organic acid, a pill core material, an adhesive, an anti-sticking agent and/or an isolation material. The discovery shows that the active ingredient and the organic acid are respectively contained in the two different pills, so that the requirement of dissolving out the active ingredient is satisfied, and the active ingredient is more uniformly dissolved out; and in addition, an isolation effect between the active ingredient and the organic acid is enhanced, so that the stability of the dabigatran etexilate medicine composition is improved.

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