- 专利标题: Preparation process for high-purity dabigatran etexilate
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申请号: US16301769申请日: 2017-05-24
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公开(公告)号: US10538507B2公开(公告)日: 2020-01-21
- 发明人: Lingjie Chen , Wenling Zhang , Peng Wang
- 申请人: ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD , ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO., LTD.
- 申请人地址: CN Taizhou CN Linhai
- 专利权人: ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD,ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO., LTD.
- 当前专利权人: ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD,ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO., LTD.
- 当前专利权人地址: CN Taizhou CN Linhai
- 代理机构: Norton Rose Fulbright US LLP
- 优先权: CN201610347598 20160524
- 国际申请: PCT/CN2017/085750 WO 20170524
- 国际公布: WO2017/202341 WO 20171130
- 主分类号: C07D235/04
- IPC分类号: C07D235/04 ; C07D401/12 ; B01D9/00
摘要:
Provided is a purifying method for dabigatran etexilate free base, comprising subjecting a dabigatran etexilate free base crude product to water slurrying to obtain a crude product B; then conducting recrystallization on the crude product B with acetone and water to obtain a crude product C; and subsequently, purifying the crude product C with a mixed solvent of tetrahydrofuran and ethyl acetate, filtering and drying to obtain a dabigatran etexilate free base finished product. The purifying method of the present invention can effectively remove various impurities and is suitable for workshop production. Salts and water-soluble organic impurities are removed by purified water slurrying, impurities with a high polarity are removed by purifying with an acetone-water solution, and impurities with a low polarity are removed by purifying with a mixed solvent of tetrahydrofuran and ethyl acetate.
公开/授权文献
- US20190152945A1 PREPARATION PROCESS FOR HIGH-PURITY DABIGATRAN ETEXILATE 公开/授权日:2019-05-23
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