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New ozagrel sodium compound and medicinal composition thereof

The technology of sodium ozagrel and compound is applied in the field of new sodium ozagrel and pharmaceutical compositions thereof, and can solve the problems of colored spots, color blocks, poor resolubility of lyophilized powder for injection, suspended particles and the like in solution, Achieving the effect of good shape, good resolubility and good appearance

Inactive Publication Date: 2012-08-01
周晓东
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the reconstitution of ozagrel sodium freeze-dried powder injection is very poor. After reconstitution, there are colored spots and blocks in the solution, the solution is turbid, the clarity is poor, and there are suspended particles, etc.

Method used

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  • New ozagrel sodium compound and medicinal composition thereof
  • New ozagrel sodium compound and medicinal composition thereof
  • New ozagrel sodium compound and medicinal composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The preparation of embodiment 1 ozagrel sodium crystalline compound

[0039] (1) Dissolve the ozagrel sodium solid in an ethanol solution with a concentration of 60% by volume, and filter; add 20ml of 60% ethanol to each gram of ozagrel sodium compound;

[0040] (2) Add a mixed solvent of anhydrous acetone and anhydrous methanol at 35°C, and stir while adding; the volume ratio of the volume sum of the added anhydrous acetone and anhydrous methanol to the ethanol solution is 1.5:1, without The volume ratio of water acetone and anhydrous methanol is 1:4; the speed of anhydrous acetone and anhydrous methanol is 1ml / min, and the stirring speed is 30 rpm;

[0041] (3) Cool down to 10°C after adding the mixed solvent, and let stand for 1 hour;

[0042] (4) The crystals were collected, washed with absolute ethanol, and vacuum-dried for 3 hours to obtain ozagrel sodium crystals.

[0043] The prepared X-ray powder diffraction measured by Cu-Kα ray is 9.4°, 11.5°, 16.4°, 17.5°, 1...

Embodiment 2

[0044] The preparation of embodiment 2 ozagrel sodium crystals

[0045] (1) Dissolve the solid sodium ozagrel in an ethanol solution with a concentration of 80% by volume, and filter; add 100 ml of ethanol to each gram of sodium ozagrel compound;

[0046] (2) Add a mixed solvent of anhydrous acetone and anhydrous methanol at 40°C, and stir while adding; the volume ratio of the volume sum of the added anhydrous acetone and anhydrous methanol to the ethanol solution is 0.5:1, without The volume ratio of water acetone and anhydrous methanol is 1:2.75; the speed of adding dropwise of anhydrous acetone and anhydrous methanol is 2ml / min; the stirring speed is 60 rev / min;

[0047] (3) Cool down to 15°C after adding the mixed solvent, and let stand for 1 hour;

[0048] (4) The crystals were collected, washed with absolute ethanol, and vacuum-dried for 3 hours to obtain ozagrel sodium crystals.

[0049] The X-ray powder diffraction of the prepared sodium ozagrel crystals measured by ...

Embodiment 3

[0050] The preparation of embodiment 3 ozagrel sodium crystals

[0051] (1) Dissolve the solid sodium ozagrel in an ethanol solution with a concentration of 75% by volume, and filter; add 80 ml of ethanol to each gram of sodium ozagrel compound;

[0052] (2) Add a mixed solvent of anhydrous acetone and anhydrous methanol at 35°C, and stir while adding; the volume ratio of the volume sum of the added anhydrous acetone and anhydrous methanol to the ethanol solution is 1.5:1, without The volume ratio of water acetone and anhydrous methanol is 1:3.5; the speed of adding dropwise of anhydrous acetone and anhydrous methanol is 1.5ml / min; the stirring speed is 90 rpm;

[0053] (3) Cool down to 10°C after adding the mixed solvent, and let stand for 1 hour;

[0054] (4) The crystals were collected, washed with absolute ethanol, and vacuum-dried for 3 hours to obtain ozagrel sodium crystals.

[0055] The X-ray powder diffraction pattern obtained by measuring the prepared sodium ozagre...

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Abstract

The invention relates to a new ozagrel sodium compound and a medicinal composition thereof. Ozagrel sodium is a crystal which is obtained by measuring by using u-K alpha rays and has characteristic peaks at 2 theta of 8.7 degrees, 10.3 degrees, 12.4 degrees, 16.2 degrees, 16.8 degrees, 19.2 degrees, 20.0 degrees, 20.7 degrees, 22.0 degrees, 22.9 degrees and 23.7 degrees during X-ray powder diffraction. The invention also relates to the medicinal composition for the ozagrel sodium compound. The medicinal composition comprises a freeze-dried powder injection or a water injection. The prepared freeze-dried powder injection has a good form, and is high in redissolution and stability, and the state of the prepared water injection is good and the prepared water injection has high stability.

Description

technical field [0001] The present invention relates to a new ozagrel sodium compound and its pharmaceutical composition. Background technique [0002] Cardiovascular and cerebrovascular diseases are diseases that seriously affect human life and health, and are also one of the diseases with high morbidity and mortality. Among them, cerebrovascular diseases occupy an important position in cardiovascular and cerebrovascular diseases. According to reports, there are as many as 1.5 million first-time cerebrovascular diseases in my country every year, and it has become the second largest disease that seriously affects the health of our people. [0003] Sodium ozagrel is a thromboxane synthase inhibitor, which can inhibit the generation of TXA2, has anti-platelet aggregation and blood vessel expansion effects, can inhibit cerebral thrombosis and cerebral vasospasm, and improve movement disorders in the acute stage of cerebral thrombosis. Clinically, it is widely used in the treat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D233/56A61K31/4174A61K9/19A61P7/02A61P9/08A61P9/10
Inventor 周晓东
Owner 周晓东
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