Sodium ozagrel compound, preparation method and drug composition thereof

A technology of ozagrel sodium and compounds, which is applied in the field of pharmaceuticals, can solve the problems of unknown stability, etc., and achieve the effect of simple and easy method, good stability performance and low loss

Active Publication Date: 2013-08-07
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The ozagrel compound crystal prepared in this patent is relatively stable under light conditions, but its stability under high temperature, high humidity and other conditions is unknown

Method used

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  • Sodium ozagrel compound, preparation method and drug composition thereof
  • Sodium ozagrel compound, preparation method and drug composition thereof
  • Sodium ozagrel compound, preparation method and drug composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Embodiment 1: Preparation of ozagrel sodium compound

[0055] (1) Prepare a saturated aqueous solution of crude sodium ozagrel at 30°C;

[0056] (2) In a sound field with a frequency of 25KHz and an output power of 80W, add a mixed organic solution of isopropanol and ether at 5°C while stirring; the volume of the mixed organic solution of isopropanol and ether added is the same as that of sodium ozagrel The volume ratio of saturated aqueous solution is 5:1; the volume ratio of isopropanol and ether is 2.5:1, and the adding speed is 24ml / min;

[0057] (3) Stop the sound field after adding the mixed solvent, cool down to 0°C, and let the crystal grow for 4 hours; the cooling rate is 3°C / min;

[0058] (4) After collection, washing with absolute ethanol, and vacuum drying for 4 hours, white powdery crystals of ozagrel sodium were obtained.

[0059] The X-ray powder diffraction pattern that this ozagrel sodium compound obtains using Cu-Kα ray measurement is as follows: fi...

Embodiment 2

[0060] Embodiment 2: Preparation of ozagrel sodium compound

[0061] (1) Prepare a saturated aqueous solution of crude sodium ozagrel at 25°C;

[0062] (2) In a sound field with a frequency of 25KHz and an output power of 50W, add a mixed organic solution of isopropanol and ether at 10°C while stirring; the volume of the mixed organic solution of isopropanol and ether added is the same as that of sodium ozagrel The volume ratio of saturated aqueous solution is 4:1; the volume ratio of isopropanol and ether is 1:1, and the adding speed is 12ml / min;

[0063] (3) After adding the mixed solvent, stop the sound field, cool down to 5°C, and let the crystal grow for 5 hours; the cooling rate is 2°C / min;

[0064] (4) Collect crystals, wash with absolute ethanol, and vacuum-dry for 2 to 6 hours to obtain white powdery crystals of ozagrel sodium.

[0065] The X-ray powder diffraction pattern that this ozagrel sodium compound obtains using Cu-Kα ray measurement is as follows: figure 1...

Embodiment 3

[0066] Embodiment 3: Preparation of ozagrel sodium compound

[0067] (1) Prepare a saturated aqueous solution of crude sodium ozagrel at 30°C;

[0068] (2) In a sound field with a frequency of 25KHz and an output power of 80W, add a mixed organic solution of isopropanol and ether at 5°C while stirring; the volume of the mixed organic solution of isopropanol and ether added is the same as that of sodium ozagrel The volume ratio of saturated aqueous solution is 3:1; the volume ratio of isopropanol and ether is 3:1, and the adding speed is 20ml / min;

[0069] (3) After adding the mixed solvent, stop the sound field, lower the temperature to 0°C, and let the crystal grow for 5 hours; the cooling rate is 1°C / min;

[0070] (4) The crystals were collected, washed with absolute ethanol, and vacuum-dried for 5 hours to obtain white powdery crystals of ozagrel sodium.

[0071] The X-ray powder diffraction pattern that this ozagrel sodium compound obtains using Cu-Kα ray measurement is ...

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Abstract

The invention relates to a sodium ozagrel compound and a preparation method thereof. The structural formula of the sodium ozagrel compound is shown in the formula I in the specification. The invention also relates to a drug composition of the sodium ozagrel compound and a preparation method thereof. The dosage forms of the drug composition include freeze-dried powder injection, small-volume injection or large-volume injection. The sodium ozagrel compound has high purity and the preparations of the sodium ozagrel compound have good stability and are suitable for clinical application.

Description

technical field [0001] The invention relates to the field of pharmacy, specifically, a compound of ozagrel sodium, its preparation method and its pharmaceutical composition. Background technique [0002] Sodium ozagrel is a thromboxane synthetase inhibitor, which can inhibit the generation of TXA2, has anti-platelet aggregation and vasodilation effects, can inhibit cerebral thrombosis and cerebral vasospasm, and improve movement disorders in the acute stage of cerebral thrombosis. It is widely used in the treatment of circulatory disorders in the acute stage of cerebral ischemia and the improvement of abnormal energy metabolism during cerebral ischemia, and has the characteristics of high safety and low price. Ozagrel sodium is a specific inhibitor of thromboxane A2 synthetase. After years of clinical application, it has been proved that it is a specific drug for the treatment of acute thrombotic cerebral infarction and the movement disorder accompanied by cerebral infarctio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D233/56A61P9/00A61P7/02A61K31/4174A61P9/10
Inventor 梁宏平
Owner HAINAN LEVTEC PHARMA
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