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Medicinal pantoprazole sodium composition for treating digestive system diseases

A technology for digestive system diseases and pantoprazole sodium, which is applied in the field of medicine, can solve the problems of unsatisfactory dissolution rate and stability of enteric-coated capsule preparations, and achieve the effect of low content of insoluble particles, low content of impurities and high purity

Inactive Publication Date: 2015-12-02
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 relates to pantoprazole sodium crystalline compounds, pharmaceutical compositions and preparation methods thereof. The present invention provides a new pantoprazole sodium crystalline compound, its pharmaceutical preparations, especially enteric-coated capsules, and their preparation methods. The chemical stability of the pantoprazole sodium crystalline compound of this 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 The fluidity of the sodium crystalline compound and the dissolution and stability of the enteric-coated capsule preparation prepared are not ideal

Method used

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  • Medicinal pantoprazole sodium composition for treating digestive system diseases
  • Medicinal pantoprazole sodium composition for treating digestive system diseases
  • Medicinal pantoprazole sodium composition for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Pantoprazole Sodium Crystals

[0023] Prepare pantoprazole sodium crude product saturated butanol solution, then add the chloroform that volume is 8 times of saturated butanol solution volume, after stirring evenly, stir while cooling, cooling speed is 8 ℃ / hour, and stirring speed is 125 Rotation per minute, while adding chloroform whose volume is 2 times the volume of chloroform, stop stirring after cooling to -5°C, let stand for crystal growth for 4 hours, filter, and dry under reduced pressure to obtain pantoprazole sodium crystalline compound.

[0024] The X-ray powder diffraction figure that the prepared pantoprazole sodium crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 shown.

Embodiment 2

[0025] Example 2: The preparation of pantoprazole sodium composition

[0026] The composition comprises: 1 part by weight of the pantoprazole sodium crystal prepared by the present invention, and 0.001 part by weight of arginine.

[0027] The preparation method is:

[0028] (1) Weigh pantoprazole sodium crystals and arginine in proportion and mix them thoroughly;

[0029] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0030] Example 3: The preparation of pantoprazole sodium composition

[0031] The composition comprises: 1 part by weight of pantoprazole sodium crystal prepared by the present invention, and 0.002 part by weight of arginine.

[0032] The preparation method is:

[0033] (1) Weigh pantoprazole sodium crystals and arginine in proportion and mix them thoroughly;

[0034] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention relates to a medicinal pantoprazole sodium composition for treating digestive system diseases and belongs to the technical field of medicine. The composition comprises pantoprazole sodium and arginine. The pantoprazole sodium is a new crystal compound, the X-ray powder diffraction diagram, obtained by using Cu-K alpha rays for measuring, of the pantoprazole sodium is shown in figure 1, and the crystal structure of the pantoprazole sodium is different from that of pantoprazole sodium in the prior art. Experiments show that the new crystal compound is high in purity, good in flowability, good in stability, low in impurity content, less prone to moisture absorption and safe and reliable in clinical application; powder injection prepared by the new crystal compound is good in stability, good in stability after being combined with solvent, extremely low in insoluble particle content and quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a medicine pantoprazole sodium composition for treating diseases of the digestive system. Background technique [0002] Pantoprazole sodium is a proton pump inhibitor, through H + -K + The covalent binding of two sites in the ATPase system inhibits the final step in gastric acid production. This effect is dose-dependent and inhibits both basal and stimulated gastric acid secretion. h + -K + The binding of ATPase can cause its antisecretory effect 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 specific. [0003] ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61P1/00A61K9/14C07D401/12
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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