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Omeprazole sodium crystal compound and medicine composition containing omeprazole sodium crystal compound

A technology of omeprazole sodium and crystal compound, which is applied in the field of omeprazole sodium crystal compound and pharmaceutical composition containing the crystal compound, can solve the problems of allergic reaction, edema, phlebitis, tissue hypoxia and the like, and achieves The effect of high product purity, good dispersibility and uniform particle size distribution

Active Publication Date: 2012-12-19
SHANDONG YUXIN PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in use, it was found that the number of insoluble particles of the preparation was not very optimistic
Insoluble particles in intravenous infusion can cause harm to the human body. For example, larger insoluble particles can cause local circulation disorders and cause vascular embolism; too many particles can cause local blockage and insufficient blood supply, and further lead to tissue hypoxia and edema. And phlebitis, can also cause granuloma, allergic reaction, pyrogen-like reaction, etc., all of which can cause harm to the human body

Method used

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  • Omeprazole sodium crystal compound and medicine composition containing omeprazole sodium crystal compound
  • Omeprazole sodium crystal compound and medicine composition containing omeprazole sodium crystal compound
  • Omeprazole sodium crystal compound and medicine composition containing omeprazole sodium crystal compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] [Example 1] Preparation of Omeprazole Sodium Crystalline Compound

[0061] 1) Dissolve 2.1kg of omeprazole sodium in 10L of water to obtain a 0.21g / mL aqueous solution of omeprazole sodium, filter it, and use the filtrate for later use;

[0062] 2) At room temperature, add the filtrate obtained in step 1) into a mixed solution of 205L acetone and isopropanol with stirring, wherein the volume ratio of acetone and isopropanol is 1:3.5, and cool down to 3°C, after obtaining crystals, continue to stir for 10 min; filter, wash the filter cake with water, and spray dry to obtain the crystalline compound of omeprazole sodium.

[0063] The obtained omeprazole sodium crystalline compound is measured by powder X-ray diffractometry, and the X-ray powder diffraction spectrum (see figure 1 ) showed characteristic diffraction peaks at 4.8°, 6.8°, 11.5°, 12.6°, 14.6°, 15.8°, 17.9°, 19.4°, 20.2°, 21.8°, 24.0°, 27.4°, 30.5° and 33.3°.

[0064] Adopt the PE Pyris Diamond TG thermal ana...

Embodiment 2-8

[0067]

[0068] The obtained omeprazole sodium crystalline compound of embodiment 2-8 is measured with powder X-ray diffractometry, and the X-ray powder diffraction pattern that expresses with 2θ ± 0.2 ° diffraction angle and adopts U.S. Perkin-Elmer company PE Pyris Diamond The thermogravimetric analysis figure that TG thermoanalyzer obtains is all similar to embodiment 1.

preparation Embodiment 1

[0069] [Preparation Example 1] Preparation of Omeprazole Sodium Freeze-dried Powder Injection

[0070] Prescription: specification (20mg / bottle)

[0071]

[0072] Preparation Process:

[0073] 1) Add the omeprazole sodium crystalline compound prepared in Example 1 and mannitol in the prescription amount into the liquid mixing tank, add 800ml of water for injection and stir until completely dissolved, and adjust the pH to 10 with 0.15mol / L sodium citrate solution .0~11.0, add water for injection to 1000ml;

[0074] 2) Add activated carbon for needles with 0.05% of the total amount of the solution, stir for 15 minutes, filter and decarbonize;

[0075] 3) Fine filter the medicinal solution with a 0.22 μm sterile microporous membrane, and measure the pH value, content, and half-stopper;

[0076] 4) Freeze-drying: pre-freeze at -40°C for 2 hours, -40-10°C, dry under reduced pressure and vacuum for 25 hours, and dry at high temperature at about 35°C for 7 hours;

[0077] 5) A...

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Abstract

The invention relates to an omeprazole sodium crystal compound, which shows characteristic diffraction peaks at 4.8-degree, 6.8-degree, 11.5-degree, 12.6-degree, 14.6-degree, 15.8-degree, 17.9-degree, 19.4-degree, 20.2-degree, 21.8-degree, 24.0-degree, 27.4-degree, 30.5-degree and 33.3-degree angles in an X-ray powder diffraction pattern which is expressed by a 2theta plus or minus 0.2-degree diffraction angle. The invention additionally relates to a preparation method of the crystal compound and a medicine composition containing the crystal compound. The crystal compound has better stability; and after a freeze-dried powder injection which is prepared by using the crystal compound is combined with four kinds of injections, the quantity of insoluble particles is fewer and the change of the quantity of the insoluble particles within 4h after combination is smaller.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a crystalline compound of omeprazole sodium and a pharmaceutical composition containing the crystalline compound. Background technique [0002] Omeprazole sodium, chemical name: 5-methoxy-2-﹛[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl﹜-1H - Benzimidazole sodium monohydrate, English name: Omeprazole Sodium for Injection, molecular weight: 385.41, molecular formula: C 17 h 18 N 3 NaO 3 S·H 2 O, the structural formula is as follows: [0003] [0004] At present, many patents have reported the preparation method and application of omeprazole and its salts, such as US4255431A, US4689333A, EP0533264A, etc. The methods include single solvent crystallization method, mixed solvent crystallization method, acid-base method, etc. Chinese patent application 95111640.1 also discloses a method for obtaining omeprazole sodium by an ion exchange resin method; Chinese patent appli...

Claims

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Application Information

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IPC IPC(8): C07D401/12A61K31/4439A61K9/19A61P1/04
Inventor 杨磊祥李明杰封春香马洪辉
Owner SHANDONG YUXIN PHARMA CO LTD
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