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Novel mitiglinide crystalline form and its preparing process

A technology of crystal form and interplanar spacing, which is applied in the field of new crystal forms, compositions containing it and its preparation, to achieve the effects of good stability, controllable product quality, and good crystal form stability

Inactive Publication Date: 2011-05-04
FOSHAN YIBAOSHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no public report on the crystal form of mitiglinide in the existing literature

Method used

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  • Novel mitiglinide crystalline form and its preparing process
  • Novel mitiglinide crystalline form and its preparing process
  • Novel mitiglinide crystalline form and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Add 5 grams of mitiglinide into a 250ml flask, add 50ml of ethanol at room temperature to dissolve it, add 2.5ml of water, shake well, place overnight for crystallization, filter, wash with 10% water-ethanol, and dry in vacuum at 40°C for 8 hours. A new crystal form of mitiglinide with a purity of 90% was obtained.

Embodiment 2

[0035] Add 5 grams of mitiglinide to a 250ml flask, add 25ml of methanol at room temperature to dissolve it, add 2.5ml of water, shake well, place overnight for crystallization, filter, wash with 20% water-methanol, and vacuum dry at 40°C for 8 hours. The new crystal form of mitiglinide with a purity of 88% was obtained.

Embodiment 3

[0037] Add 5 grams of mitiglinide to a 250ml flask, add 200ml of isopropanol at room temperature to dissolve it, add 5ml of water, shake well and place it overnight for crystallization, filter, wash with 5% water-isopropanol, and vacuum dry at 45°C After 8 hours, a new crystal form of mitiglinide with a purity of 85% was obtained.

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PUM

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Abstract

The invention relates to a novel crystalline form of mitiglinide drug for treating diabetes, composite comprising same and its preparation process. Mitiglinide is a medicine for treating Type-11 diabetes, and its chemical name is (-)-2(s)-benzyl-4-oxy-4-(cis-perhydro iso indole -2-yl) calcium butyrate dihydrate. The novel crystalline form has high stability.

Description

Technical field: [0001] The invention relates to a crystal form of a medicine for treating diabetes, especially a new crystal form of mitiglinide, a composition containing it and a preparation method thereof. Background technique: [0002] The chemical name of mitiglinide is (—)—2(S)—benzyl—4—oxo—4—(cis-perhydroisoindol—2—yl) butyric acid calcium salt dihydrate. Miglinide is a new type of drug for the treatment of type II diabetes. Compared with traditional sulfonylurea drugs, it has a rapid onset of action and a short duration of action after administration. It can inhibit postprandial hyperglycemia characteristic of type II diabetes and has high safety. , good tolerance; compared with repaglinide and nateglinide, which belong to the same class of meglitaide, it has stronger efficacy. Relevant information disclosure has: U.S. Patent US6133454, US5202335; European Patent EP 0967204; Chem.Pharm.Bull.1997,45(9):1518~1520 and 1998,46(2):337~340; (10): 1034-1042. There is no ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D209/44A61K31/4035A61K9/00A61P3/10
Inventor 姚勇敢
Owner FOSHAN YIBAOSHENG PHARMA CO LTD
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