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Novel mitiglinide crystalline form and its preparing process

A technology of crystal form and interplanar spacing, applied to the composition containing it and its preparation, and the field of new crystal forms, to achieve the effects of no reduction in drug content, good stability, and good crystal form stability

Inactive Publication Date: 2005-07-06
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 to a 250ml flask, add 50ml of ethanol at room temperature to dissolve it, add 2.5ml of water, shake well and let stand overnight for crystallization, filter, wash with 10% water-ethanol, and dry at 40°C under vacuum for 8 hours. A new crystal form of mitiglinide with a purity of 90% was obtained.

Embodiment 2

[0035] Add 5 g of mitiglinide to a 250 ml flask, add 25 ml of methanol at room temperature to dissolve it, add 2.5 ml of water, shake well and let stand overnight for crystallization, filter, wash with 20% water-methanol, and dry at 40°C for 8 hours. A 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 to dissolve it at room temperature, add 5ml of water, shake well and let stand overnight for crystallization, filter, wash with 5% water-isopropanol, and dry at 45°C under vacuum In 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, in particular 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. Mitiglinide is a new type of drug for the treatment of type II diabetes. Compared with traditional sulfonylurea drugs, it has a rapid onset and short action time after administration. It can inhibit postprandial hyperglycemia characteristic of type II diabetes with high safety. , Good tolerability; Compared with repaglinide and nateglinide, which belong to the same meglitinide drugs, the curative effect is stronger. Related information disclosures include: US patents US 6133454, US5202335; European patent EP 0967204; Chem. Pharm. Bull. 1997, 45(9): 1518-1520 and 1998, 46(2): 337-340; Drugs of the Future 2000 , 25(10): 1...

Claims

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Application Information

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