NEW CRYSTAL FORM OF PANTOPRAZOLE SODIUM COMPOUND AND PREPARATION METHOD THEREFOR

Title:

NEW CRYSTAL FORM OF PANTOPRAZOLE SODIUM COMPOUND AND PREPARATION METHOD THEREFOR

Document Type and Number:

WIPO Patent Application WO/2016/127684

Kind Code:

A1

Abstract:

Disclosed are a new crystal form of a pantoprazole sodium compound and a preparation method therefor. The new crystal form is referred to as an M crystal form. The diffraction angle of 2 θ° of X-ray powder diffraction pattern and the characteristic peak of the DSC are used for definition. A pantoprazole sodium solid is added into an alcohol solvent for preparing a suspension liquid of 0.05-0.2 g/mL; an antioxidant is added into the suspension liquid, and the solid is completely dissolved at 15-35°C; a solvating-out agent is added dropwise into the solution under the effect of ultrasound, with the amount of the solvating-out agent being 3-10 times the volume of the alcohol solvent; then the solution is cooled to 0-5°C; stirring is continued for 1-3 h; the formed suspension liquid is filtered by suction; and a pantoprazole sodium crystal product is dried to a constant weight to obtain the new crystal form. The thermal stability test of the product shows that the crystal form product has higher thermal stability. Moreover, the crystal form product has a higher bulk density and better mobility, and facilitates the following preparation process, product storage, transportation and the like.

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Inventors:

HAO HONGXUN (CN)
TAO LINGGANG (CN)
JIANG SHEN (CN)
WANG YONGLI (CN)
WANG JINGKANG (CN)
LV JUN (CN)
YIN QIUXIANG (CN)
HOU BAOHONG (CN)
XU ZHAO (CN)
XIE CHUANG (CN)
WANG ZHAO (CN)

Application Number:

PCT/CN2015/095231

Publication Date:

August 18, 2016

Filing Date:

November 20, 2015

Export Citation:

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Assignee:

UNIV TIANJIN (CN)
HAINAN LINGKANG PHARMACEUTICAL (CN)

International Classes:

C07D401/12; A61K9/14; A61K9/28; A61K31/4439; A61P1/04

Domestic Patent References:

WO2004056804A2	2004-07-08
WO2004099183A1	2004-11-18

Foreign References:

CN103709140A	2014-04-09
CN102796078A	2012-11-28

Attorney, Agent or Firm:

BEIJING CONCEPT INTELLECTUAL PROPERTY AGENCY (CN)
北京康思博达知识产权代理事务所（普通合伙） (CN)

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