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Pantoprazole sodium composition for treating gastric diseases

A technology of pantoprazole sodium and composition, which is applied in the field of pantoprazole sodium composition for treating stomach diseases, can solve the problems of unsatisfactory dissolution and stability of liquid enteric-coated capsule preparations, and achieve the content of insoluble particles Low, high purity, not easy to absorb moisture

Inactive Publication Date: 2015-11-18
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] ZL201310093503.3 Pantoprazole sodium crystalline compound, pharmaceutical composition and preparation method thereof, the present invention provides a new pantoprazole sodium crystalline compound, its pharmaceutical preparation, especially enteric-coated capsules, and their preparation method, the present invention The chemical stability of the pantoprazole sodium crystalline compound of invention is better, and solubility is better, has improved the safety of medicine, is beneficial to the long-term storage of medicine, has provided safety guarantee for medicine clinical application, but its pantoprazole sodium The fluidity of the crystalline compound and the dissolution rate and stability of the prepared enteric-coated capsule preparation are not ideal

Method used

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  • Pantoprazole sodium composition for treating gastric diseases
  • Pantoprazole sodium composition for treating gastric diseases
  • Pantoprazole sodium composition for treating gastric diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Preparation of Pantoprazole Sodium Crystals

[0027] (1) Prepare ethanol and N,N-dimethylformamide as a mixed solvent, and the volume ratio of ethanol and N,N-dimethylformamide is 2:1;

[0028] (2) get pantoprazole sodium crude drug, be dissolved in the volume of step (1) in the mixed solvent of ethanol, N,N-dimethylformamide of 6 times of weight of pantoprazole sodium, be warming up to 35 ℃, stirred until all dissolved to obtain pantoprazole sodium solution;

[0029] (3) Under the condition of a stirring speed of 560r / min, the pantoprazole sodium solution in step (2) is added to isoamyl alcohol whose volume is 5 times the weight of pantoprazole sodium, and mixed to form a suspension , cooling down to -10°C at a rate of 10°C / min;

[0030] (4) Carry out suction filtration, wash the filter cake, and then vacuum-dry the filter cake to obtain a crystalline powder, which is the described pantoprazole sodium compound.

[0031] The X-ray powder diffraction figu...

Embodiment 2

[0032] Example 2: The preparation of pantoprazole sodium composition

[0033] The composition comprises: 1 part by weight of the pantoprazole sodium crystal prepared by the present invention, and 0.04 part by weight of sodium chloride.

[0034] The preparation method is:

[0035] (1) Weigh pantoprazole sodium crystals and sodium chloride in proportion and mix them thoroughly;

[0036] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0037] Example 3: The preparation of pantoprazole sodium composition

[0038] The composition comprises: 1 part by weight of the pantoprazole sodium crystal prepared by the invention, and 0.05 part by weight of sodium chloride.

[0039] The preparation method is:

[0040] (1) Weigh pantoprazole sodium crystals and sodium chloride in proportion and mix them thoroughly;

[0041] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention discloses a pantoprazole sodium composition for treating gastric diseases, belonging to the technical field of medicines. The composition is prepared from pantoprazole sodium and sodium chloride, wherein pantoprazole sodium is a crystal. An X-ray powder diffraction pattern obtained through measurement by using a Cu-Kalpha ray is shown in a drawing 1 in the specification. A new crystal form of pantoprazole sodium provided by the invention is different from the crystal structure of the prior art. Through experimental verification, the compound in the new crystal form has high purity, good flowability and stability and low impurity content, has low possibility of moisture absorption and is safe and reliable to apply clinically. Powder injections prepared by utilizing the compound in the new crystal form have good stability after undergoing compatibility with solvents, have low content of insoluble particles and are very suitable to apply clinically.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a medicine composition of pantoprazole sodium for treating stomach diseases. Background technique [0002] Pantoprazole sodium is a proton pump inhibitor that inhibits the final step of gastric acid production by covalently binding to two sites of the H+-K+ATPase system of gastric parietal cells. This effect is dose-dependent and inhibits both basal and stimulated gastric acid secretion. The combination of H+-K+ATPase can cause its anti-secretion effect of gastric acid to last for more than 24 hours. Pantoprazole sodium is the third proton pump inhibitor listed after omeprazole and lansoprazole. Because the substituent groups of pantoprazole sodium on the pyridine ring and benzimidazole ring are different from those of omeprazole and lansoprazole, thus determining the difference in its biochemical, pharmacokinetic and pharmacological properties , making it more selective and s...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K31/4439A61K9/00C07D401/12A61P1/04
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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