CRYSTAL FORM OF DABIGATRAN ETEXILATE MESYLATE AND PREPARATION METHOD AND USE THEREOF
    2.
    发明公开
    CRYSTAL FORM OF DABIGATRAN ETEXILATE MESYLATE AND PREPARATION METHOD AND USE THEREOF 审中-公开
    侠盗猎车手侠盗猎车手

    公开(公告)号:EP3115360A1

    公开(公告)日:2017-01-11

    申请号:EP15759282.5

    申请日:2015-03-04

    摘要: The present invention relates to novel crystal forms M and N of dabigatran etexilate mesylate and preparation method and uses thereof, wherein the X-Ray powder diffractogram of the crystal form M has characteristic peaks at the following 2θ diffraction angles: 5.7±0.2°, 6.2±0.2°, 11.2±0.2°, 12.4±0.2°, 18.2±0.2°, 21.4±0.2°, 21.8±0.2° and 23.6±0.2°; and the X-Ray powder diffractogram of the crystal form N has characteristic peaks at the following 2θ diffraction angles: 6.0±0.2°, 11.8±0.2°, 18.2±0.2°, 21.6±0.2°, 24.4±0.2°, 27.7±0.2° and 29.7±0.2°. The crystal forms of the present invention have excellent properties in the aspects of leaching time, biological release, chemical stability and processing adaptability.

    摘要翻译: 本发明涉及甲磺酸达比加群酯的新型结晶形式M和N及其制备方法和用途,其中晶型M的X射线粉末衍射图在以下2θ衍射角为5.7±0.2°处具有特征峰, 6.2±0.2°,11.2±0.2°,12.4±0.2°,18.2±0.2°,21.4±0.2°,21.8±0.2°和23.6±0.2°; 晶体形式N的X射线粉末衍射图在以下2θ衍射角处具有特征峰:6.0±0.2°,11.8±0.2°,18.2±0.2°,21.6±0.2°,24.4±0.2°,27.7± 0.2°和29.7±0.2°。 本发明的结晶形式在浸出时间,生物释放,化学稳定性和加工适应性方面具有优异的性能。