Title:
PREPARATION PROCESS FOR HIGH-PURITY DABIGATRAN ETEXILATE
Document Type and Number:
WIPO Patent Application WO/2017/202341
Kind Code:
A1
Abstract:
Provided is a refining 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, refining 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 refining 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 refining with an acetone-water solution, and impurities with a low polarity are removed by refining with a mixed solvent of tetrahydrofuran and ethyl acetate.
Inventors:
CHEN LINGJIE (CN)
ZHANG WENLING (CN)
WANG PENG (CN)
ZHANG WENLING (CN)
WANG PENG (CN)
Application Number:
PCT/CN2017/085750
Publication Date:
November 30, 2017
Filing Date:
May 24, 2017
Export Citation:
Assignee:
ZHEJIANG HUAHAI PHARM CO LTD (CN)
ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO LTD (CN)
ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO LTD (CN)
International Classes:
C07D401/12
Domestic Patent References:
| WO2014041559A2 | 2014-03-20 |
Foreign References:
| EP2610251A1 | 2013-07-03 |
Other References:
See also references of EP 3444244A4
Attorney, Agent or Firm:
PATENTSINO IP FIRM (CN)
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