Pharmaceutical composition of pantoprazole sodium and preparation method thereof

A technology of pantoprazole sodium and composition, which is applied in the field of pharmaceutical composition of pantoprazole sodium and its preparation, can solve problems such as unclear product stability, inapplicability to large-scale production, and influence on product stability, To achieve the effect of ensuring the safety of medication, reducing the dosage and speeding up the speed

Active Publication Date: 2013-04-24
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the above prescription, too many types and dosages of excipients are added, and a large number of excipients may interact with each other during storage to affect the stability of the product, which is not conducive to promotion
[0008] Chinese patent 200910019756.X discloses a pantoprazole sodium compound and its preparation method, and the purity of the refined product of pantoprazole can reach 99.8%, but the stability of the product is not tested in this patent , the stability of the product is not yet clear, and this method uses macroporous resin for purification, which is costly and cumbersome, and is not suitable for large-scale production

Method used

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  • Pharmaceutical composition of pantoprazole sodium and preparation method thereof
  • Pharmaceutical composition of pantoprazole sodium and preparation method thereof
  • Pharmaceutical composition of pantoprazole sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] (1) Dissolve pantoprazole sodium solid in distilled water at 40°C, and add a mixed solvent of anhydrous methanol, anhydrous isopropanol and acetone while stirring under a sound field with a frequency of 25KHz and an output power of 30W; among them, The volume ratio of anhydrous methanol, anhydrous isopropanol and acetone is 5:4:1; the volume ratio of the mixed solvent to the solid aqueous solution of pantoprazole sodium is 3.5:1.

[0040] (2) After adding the mixed solvent, lower the temperature to 1°C to obtain crystals and then stand for crystallization; filter, wash the filter cake with absolute ethanol, and vacuum-dry for 6 hours to obtain pantoprazole sodium crystals; the cooling rate is 2.5 °C / min.

[0041] The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement of the prepared pantoprazole sodium is as follows figure 1 Shown; detected by high performance liquid chromatography, its purity is 99.96%; melting point 203 ~ 205 ℃.

Embodiment 2

[0043] (1) Dissolve pantoprazole sodium solid in distilled water at 45°C, and add a mixed solvent of anhydrous methanol, anhydrous isopropanol and acetone while stirring under a sound field with a frequency of 25KHz and an output power of 60W; anhydrous The volume ratio of methanol, anhydrous isopropanol and acetone is 5:4:2; the volume ratio of the mixed solvent to the solid aqueous solution of pantoprazole sodium is 3:1.

[0044] (2) After adding the mixed solvent, cool down to 2°C to obtain crystals and then stand for crystallization; filter, wash the filter cake with absolute ethanol, and vacuum dry for 8 hours to obtain pantoprazole sodium crystals; the cooling rate is 3.5 °C / min.

[0045] The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement of the prepared pantoprazole sodium is as follows figure 1 Shown; detected by high performance liquid chromatography, its purity is 99.95%; melting point: 203 ~ 205 ℃.

Embodiment 3

[0047] (1) Pantoprazole sodium solid is dissolved in distilled water, under the sound field that frequency is 25KHz, output power is 60W, add the mixed solvent of anhydrous methanol, anhydrous isopropanol and acetone while stirring; Said mixed solvent The volume ratio of pantoprazole sodium solid aqueous solution is 3.25:1.

[0048] (2) After adding the mixed solvent, lower the temperature to 5°C, obtain crystals and then stand for crystallization; filter, wash the filter cake with absolute ethanol, and vacuum-dry for 7 hours to obtain pantoprazole sodium crystals; among them, anhydrous The volume ratio of methanol, anhydrous isopropanol and acetone is 5:4:1.5; the cooling rate is 3°C / min.

[0049] The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement of the prepared pantoprazole sodium is as follows figure 1 Shown; detected by high performance liquid chromatography, its purity is 99.95%; melting point: 203 ~ 205 ℃.

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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.

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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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/4439A61P1/04C07D401/12
Inventor 王进宇王恒南吴清刚黎李
Owner HAINAN JINRUI PHARMA CO LTD
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