Pharmaceutical composition of pantoprazole sodium and preparation method thereof

A technology of pantoprazole sodium and its composition is applied in the pharmaceutical composition of pantoprazole sodium and its preparation field, which can solve problems such as inapplicability to large-scale production, unclear product stability, and influence on product stability. To achieve the effect of ensuring the safety of medication, speeding up the speed and reducing the dosage
CN103054797BActive Publication Date: 2014-02-26HAINAN JINRUI PHARMA CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HAINAN JINRUI PHARMA CO LTD
Publication Date
2014-02-26

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Abstract

The invention relates to pantoprazole sodium, and in particular relates to a pharmaceutical composition of pantoprazole sodium. The pharmaceutical composition contains pantoprazole sodium, sodium chloride and an excipient, wherein the weight ratio of pantoprazole sodium to sodium chloride and the excipient is 10:(1-5):(5-20), and preferably 10:(1-3):(8-16); and the excipient is at least one selected from mannitol, glucose, dextran, sorbitol and lactose, and preferably mannitol or sorbitol. The pharmaceutical composition of pantoprazole sodium is low in impurity content and high in stability and is applicable to clinical application.
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Description

technical field

[0001] The invention relates to pantoprazole sodium, in particular to a pharmaceutical composition of pantoprazole sodium and a preparation method thereof. Background technique

[0002] Pantoprazole sodium, English name: Pantoprazole Sodium, its chemical name is: 5-difluoromethoxy-2-[[(3,4-dimethoxy-2-pyridyl)-methyl]sulfinic acid Acyl]-1H-benzimidazole sodium monohydrate. 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.

[0003] Pantoprazole sodium (trade name: Pantoloc) is a product developed and developed by Byk Gulden Pharmaceuticals, Germany. It is the third proton pump inhibitor to be marketed after omeprazole and lansoprazole. Because t...

Claims

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