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Pantoprazole sodium composition freeze-dried powder injection for injection

A technology of pantoprazole sodium and freeze-dried powder injection, which is applied in the field of pharmaceuticals and pharmaceutical manufacturing, can solve problems such as non-stop use, achieve the effects of reducing dosage, changing membrane operation mechanism, and inhibiting gastric acid secretion

Inactive Publication Date: 2014-02-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Pantoprazole sodium acts on the key enzyme H+ / K+-ATPase in the final step of gastric acid secretion in parietal cells, while chitosan nanoparticles can adsorb this enzyme, and eventually make it irreversibly inactivated, and the acid inhibition effect is stronger And the effect is long-lasting, the speed of promoting ulcer healing is faster, and the healing rate is higher. It is suitable for the treatment of various refractory ulcers or NSAID ulcer patients who cannot stop using NSAID. Pharmaceutical dosage form

Method used

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  • Pantoprazole sodium composition freeze-dried powder injection for injection
  • Pantoprazole sodium composition freeze-dried powder injection for injection
  • Pantoprazole sodium composition freeze-dried powder injection for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0030] Embodiment 1, the preparation of pantoprazole sodium composition freeze-dried powder for injection, in 1000 pieces.

[0031] prescription:

[0032] Pantoprazole Sodium 20g

[0033] Chitosan Nanoparticles 12g

[0034] Water for injection 2000ml

[0035] 2. Preparation process:

[0036] The chitosan nanoparticle that takes by weighing 12g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0037] Add 20 g of pantoprazole sodium and stir to dissolve until clear.

[0038] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , calculated according to pantoprazole sodium 20mg per bottle.

[0039] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down t...

Embodiment 2

[0040] Embodiment two, the preparation of the freeze-dried powder injection of pantoprazole sodium composition for injection, in 1000.

[0041] 1. Prescription:

[0042] Pantoprazole Sodium 20g

[0043] Chitosan Nanoparticles 8g

[0044] Water for injection 2000ml

[0045] 2. Preparation process:

[0046] The chitosan nanoparticle that weighs 8g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0047] Add 20 g of pantoprazole sodium and stir to dissolve until clear.

[0048] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , calculated according to pantoprazole sodium 20mg per bottle.

[0049] Fill according to the test requirements, put it into a freeze dryer after half-tamping, coo...

Embodiment 3

[0050] Embodiment three, the preparation of pantoprazole sodium composition freeze-dried powder for injection, in 1000 pieces.

[0051] prescription:

[0052] Pantoprazole Sodium 20g

[0053] Chitosan Nanoparticles 16g

[0054] Water for injection 2000ml

[0055] 2. Preparation process:

[0056] The chitosan nanoparticle that takes by weighing 16g is slowly added in the water for injection of 2000ml, while adding, stir until dissolving.

[0057] Add 20 g of pantoprazole sodium and stir to dissolve until clear.

[0058] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , calculated according to pantoprazole sodium 20mg per bottle.

[0059] Fill according to the test requirements, put it into a freeze dryer after half-tamping, co...

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Abstract

The invention provides a pantoprazole sodium composition freeze-dried powder injection for injection, and relates to the technical field of medicines and medicine preparation. The pantoprazole sodium composition freeze-dried powder injection for injection comprises the following raw material components in parts by weight: 7.24-9.08 parts of pantoprazole sodium, 4.34-5.45 parts of chitosan nanoparticles and 85.25-89.11 parts of water for injection. The pantoprazole sodium composition freeze-dried powder injection has the advantages that 1) the composition formed in proportion of 1:0.6 (pantoprazole sodium: chitosan nanoparticles) has a stronger inhibiting effect on H+-K+ATP (Adenosine Triphosphate); 2) the use level of pantoprazole sodium can be clinically reduced, the adverse reaction of pantoprazole sodium can be reduced, the effect for inhibiting gastric acid secretion of 20mg of pantoprazole sodium containing chitosan nanoparticles is equal to that of 30mg of pantoprazole sodium which does not contain chitosan nanoparticles; 3) the medicine further has good stability while the water solubility of the medicine is improved; 4) medicine-carrying nanoparticles can change membrane transfer mechanism and increase permeability of the medicine to biological membranes, thereby facilitating effect exertion of the medicine in cells; 5) the chitosan nanoparticles can replace mannitol as a freeze-dried skeleton agent of the freeze-dried powder injection, so that the activity of mannitol on a human body is eliminated.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a pantoprazole sodium composition freeze-dried powder for injection. Background technique: [0002] Pantoprazole sodium Chinese chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzimidazole sodium salt. The structural formula is as follows: [0003] [0004] This product is a proton pump inhibitor of gastric parietal cells, which can specifically inhibit the H+ / K+-ATPase on the secretory microtubules formed by the apical membrane of the parietal cells and the tubular vesicles in the cytoplasm, causing irreversible inhibition of the enzyme, thereby Effectively inhibit the secretion of gastric acid. Since H+ / K+-ATPase is the last process of parietal cell acid secretion, this product has a strong ability to suppress acid. It can not only non-competitively inhibit gastric acid secretion caused by gastrin, histamine, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/36A61P1/04
CPCA61K9/0019A61K9/19A61K31/4439A61K47/36A61P1/04
Inventor 汪六一汪金灿周顶文
Owner HAINAN WEI KANG PHARMA QIANSHAN