Omeprazole sodium crystalline compound, preparation method and medicine composition thereof

A technology for omeprazole sodium and crystallization, which is applied in the field of crystallization preparation and pharmaceutical preparations, can solve the problems such as complicated preparation method, disadvantage, increase cost, etc., and achieve the effects of simple preparation method, low hygroscopicity and easy handling.

Active Publication Date: 2013-04-03
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen from the above that the preparation methods of the latter two crystals are actually quite cumbersome. They need to ...

Method used

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  • Omeprazole sodium crystalline compound, preparation method and medicine composition thereof
  • Omeprazole sodium crystalline compound, preparation method and medicine composition thereof
  • Omeprazole sodium crystalline compound, preparation method and medicine composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Add 5.0 g of omeprazole sodium to 20 ml of water to dissolve, then add 95 ml of a mixed solution of isoamyl alcohol and 2-butanone at a volume ratio of 1:6, and then stir the mixture at 18°C ​​for 1 hour, and then in Stir at 5°C for 2 hours. Then stand still for 6 hours, filter the obtained crystals with suction, wash with 20 ml of propanol, and dry to obtain 4.15 g of V-type crystals.

[0039] The X-ray diffraction analysis figure and infrared spectrum figure of this crystal are respectively figure 1 and figure 2 .

[0040]

Embodiment 2

[0042] Add 10.0 g of omeprazole sodium to 50 ml of water to dissolve, then add 135 ml of a mixed solution of isoamyl alcohol and 2-butanone at a volume ratio of 1:8, and then stir the mixture at 16°C for 1.5 hours, then in Stir at 8°C for 2 hours. Then stand still for 8 hours, filter the obtained crystals with suction, wash with 50 ml of propanol, and dry to obtain 8.45 g of V-type crystals.

[0043] The X-ray diffraction analysis figure and infrared spectrogram of the crystal are basically the same as those in Example 1.

[0044]

Embodiment 3

[0046] Add 13.0 g of omeprazole sodium to 55 ml of water to dissolve, then add 140 ml of a mixed solution of isoamyl alcohol and 2-butanone at a volume ratio of 1:9, and then stir the mixture at 18°C ​​for 2 hours, and then in Stir at 8°C for 3.5 hours. Then stand still for 10 hours, filter the obtained crystals with suction, wash with 60 ml of propanol, and dry to obtain 11.12 g of V-type crystals.

[0047] The X-ray diffraction analysis figure and infrared spectrogram of the crystal are basically the same as those in Example 1.

[0048]

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PUM

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Abstract

The invention provides a V-type crystal of omeprazole sodium with diffraction angles of 3.8 DEG, 5.4 DEG, 7.2 DEG, 11.7 DEG, 14.6 DEG, 18.1 DEG, 23.5 DEG and 26.8 DEG expressed by 2 theta in powder X-ray diffraction analysis. The V-type crystal has excellent stability and solubility and low hygroscopicity. The invention also provides a preparation method of the crystal, a medicine composition and a medicine preparation comprising the V-type crystal, especially a powder injection.

Description

technical field [0001] The invention relates to the fields of crystal preparation and pharmaceutical preparations, in particular to a crystalline compound of omeprazole sodium, a preparation method and a pharmaceutical composition thereof. Background technique [0002] Omeprazole sodium, chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl}-1H - Sodium benzimidazole monohydrate, the molecular formula is C 17 h 18 N 3 NaO 3 S·H 2 O, molecular weight: 385.41. [0003] Omeprazole sodium is a racemic mixture of a pair of active optical enantiomers. It reduces the secretion of gastric acid through a highly targeted mechanism of action. It is a special inhibitor of the acid pump in gastric parietal cells. It is a fast-acting, once-daily dose that reversibly suppresses gastric acid secretion. It is a weakly alkaline substance that is concentrated and converted into an active substance in the highly acidic environment of the intracellular tubules o...

Claims

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Application Information

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IPC IPC(8): C07D401/12A61K31/4439A61K9/08A61P1/04
Inventor 宁辉
Owner 双鹤药业(海南)有限责任公司
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