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Pantoprazole sodium compound and pharmaceutical composition thereof

A pantoprazole sodium and compound technology, applied in the field of pantoprazole sodium compounds and pharmaceutical compositions thereof, can solve the problems of limited application, extremely strict requirements on preparation process parameters, limited degree of stability of pharmaceutical preparations, etc. The effect of water stabilization

Active Publication Date: 2012-02-15
江西新先锋医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] As can be seen from each of the above-mentioned disclosed documents, in the prior art, screening experiments are mainly carried out on aspects such as the preparation process parameters of the pantoprazole sodium pharmaceutical preparation, the type or quantity of the adjuvant used, thereby improving the stability of the pharmaceutical preparation, but The degree of stability of the improved pharmaceutical preparation is limited, and the preparation process parameters are extremely strict, thus limiting the application of pantoprazole sodium preparations

Method used

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  • Pantoprazole sodium compound and pharmaceutical composition thereof
  • Pantoprazole sodium compound and pharmaceutical composition thereof
  • Pantoprazole sodium compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] [embodiment 1] the preparation of pantoprazole sodium compound

[0066] 1) Dissolve pantoprazole sodium powder in a water / methanol mixed solution with a volume ratio of 1:3.5, heat the mixed solution at 45°C, stir at a speed of 900 rpm for 20min, and then filter while hot to obtain the filtrate 1;

[0067] 2) Stir the filtrate 1 at a speed of 1350 rpm, while keeping the temperature of the filtrate 1 at 12.5° C., add pre-cooled diethyl ether to the filtrate 1 until the solution appears white turbidity, and obtain solution 2, wherein the temperature of the pre-cooled diethyl ether 12.5°C;

[0068] 3) Stop stirring, let the solution stand at 12.5°C for 215h to precipitate crystals, filter, wash the filter cake with pre-cooled ether, and vacuum dry the filter cake at 40°C for 18h to obtain the pantoprazole sodium compound.

[0069] The obtained pantoprazole sodium compound uses the X-ray powder diffraction figure obtained by Cu-Kα ray measurement (see figure 1 ) in the c...

Embodiment 2

[0070] [embodiment 2] the preparation of pantoprazole sodium compound

[0071] 1) Dissolve pantoprazole sodium powder in a water / methanol mixed solution with a volume ratio of 1:5, heat the mixed solution at 40°C, stir at a speed of 1000 rpm for 20min, and then filter while hot to obtain the filtrate 1;

[0072] 2) Stir the filtrate 1 at a speed of 1500 rpm, while keeping the temperature of the filtrate 1 at 10° C., add pre-cooled diethyl ether to the filtrate 1 until the solution appears white turbidity, and obtain solution 2, wherein the temperature of the pre-cooled diethyl ether 10°C;

[0073] 3) Stop stirring, let the solution stand at 15° C. for 220 h to precipitate crystals, filter, wash the filter cake with pre-cooled ether, and vacuum dry the filter cake at 50° C. for 24 h to obtain the pantoprazole sodium compound.

[0074] The obtained pantoprazole sodium compound, its melting point and the X-ray powder diffraction pattern measured using Cu-K α rays are consistent...

Embodiment 3

[0075] [embodiment 3] the preparation of pantoprazole sodium compound

[0076] 1) Dissolve pantoprazole sodium powder in a water / methanol mixed solution with a volume ratio of 1:2, heat the mixed solution at 50°C, stir at a speed of 800 rpm for 20min, and then filter while it is hot to obtain the filtrate 1;

[0077] 2) Stir the filtrate 1 at a speed of 1200 rpm, while keeping the temperature of the filtrate 1 at 15°C, add pre-cooled ether to the filtrate 1 until the solution appears white turbidity, and obtain solution 2, wherein the temperature of the pre-cooled ether 15°C;

[0078] 3) Stop stirring, let the solution stand at 10° C. for 210 h to precipitate crystals, filter, wash the filter cake with pre-cooled ether, and dry the filter cake 12 under vacuum at 30° C. to obtain the pantoprazole sodium compound.

[0079] The obtained pantoprazole sodium compound, its melting point and the X-ray powder diffraction pattern measured using Cu-K α rays are consistent with those o...

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Abstract

The invention discloses a pantoprazole sodium compound, which is crystal. In X-ray powder diffraction pattern obtained through Cu-Kalpha ray measurement, the characteristic peaks of the pantoprazole sodium compound are shown in positions where 2theta is 12.5, 12.6, 13.2, 16.2 and 17.3. The pantoprazole sodium compound can be used together with multiple freeze-drying supporting agents, the prepared freeze-dried powder injection has the advantages of good redissolution, good transparency after redissolution, low impurity content and the like; and moreover, the use amount of the freeze-drying supporting agent is lower, thus saving the pharmaceutical cost and improving the stability of a drug preparation. The invention also discloses a pharmaceutical composition. The pharmaceutical composition comprises a pharmaceutical active ingredient and pharmaceutical auxiliary materials, wherein the pharmaceutical active ingredient is the pantoprazole sodium compound. The stability of the pharmaceutical composition is obviously superior to that of commercial products, and especially, the stability duration of the pharmaceutical composition after being matched with common infusion fluid is prolonged, thus facilitating the clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pantoprazole sodium compound and a pharmaceutical composition thereof. Background technique [0002] Pantoprazole sodium, the chemical name is 5-difluoromethoxy-2-{[(3,4-dimethoxy-2-pyridyl)-methyl]-sulfinyl}-1H-benzo Imidazole sodium salt-hydrate, its molecular formula is: C16H14F2N3NaO4S·H2O, molecular weight: 423.38. It is mainly used clinically for the treatment of acid-related diseases: including duodenal ulcer, gastric ulcer, reflux esophagitis and Zoller-Ellison syndrome, especially for ulcers with bleeding, vomiting or inability to eat, as well as refractory ulcers and Acute pancreatitis. It can also be used to prevent stress ulcers caused by major surgery or severe trauma. [0003] Because pantoprazole sodium has the chemical structure of sulfinyl benzimidazole, its stability is easily affected by various factors such as light, heavy metal ions, oxidizi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61K9/19A61P1/04A61P1/00A61P1/08
Inventor 夏智红
Owner 江西新先锋医药有限公司
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