Omeprazole sodium lyophilized preparation for injection and preparation method thereof

A technology of omeprazole sodium and freeze-dried preparations, applied in the field of medicine, can solve the problems of being difficult to be stabilized and the properties of omeprazole sodium are unstable, and achieve improved drug release rate, small particle size, and Zeta potential. improved effect

Inactive Publication Date: 2009-01-28
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the problem that Omeprazole Sodium is unstable and difficult to make stable water preparation, th

Method used

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  • Omeprazole sodium lyophilized preparation for injection and preparation method thereof
  • Omeprazole sodium lyophilized preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0020] raw material:

[0021] Omeprazole Sodium 20g

[0022] Dextran 20g

[0023] Povidone K15 5g

[0024] Sodium sulfite 5g

[0025] Polymethylmethacrylate 40g

[0026] Lactose 10g.

[0027] Preparation Process

[0028] (1) Take by weighing 20g omeprazole sodium, 20g dextran, 5g povidone K15, add 1000ml of water for injection to dissolve, adjust the pH value to 2.5 with the hydrochloric acid solution of 1mol / L, stir;

[0029] (2) Slowly add 40g polymethyl methacrylate under electromagnetic stirring, continue to stir for 3 hours at room temperature, add 5g of sodium sulfite, continue to stir for 3 hours, adjust the pH value to 12 with 1mol / L sodium hydroxide solution, stir Uniform;

[0030] (3) Add 10 g of lactose, stir to dissolve, then add 0.1% of the total volume of the solution with charcoal for needles, stir at room temperature for 10 minutes, filter for decarburization, and then fine filter with a 0.22 μm microporous membrane to obtain omeprazole sodium nanopartic...

example 2

[0033] raw material:

[0034] Omeprazole Sodium 40g

[0035] Dextran 200g

[0036] Povidone K30 60g

[0037] Sodium sulfite 40g

[0038] Polymethylmethacrylate 400g

[0039] Glucose 500g.

[0040] Preparation Process

[0041] (1) Take by weighing 40g omeprazole sodium, 200g dextran and 60g povidone K30, add 3000ml of water for injection to dissolve, adjust the pH value to 2.8 with the hydrochloric acid solution of 1mol / L, stir;

[0042] (2) Slowly add 400g polymethyl methacrylate under electromagnetic stirring, continue stirring for 3 hours at room temperature, add 40g sodium sulfite, continue stirring for 3 hours, adjust the pH value to 9 with 1mol / L sodium hydroxide solution, stir Uniform;

[0043] (3) Add 500 g of glucose, stir to dissolve, then add 0.3% of the total volume of the solution with charcoal for needles, stir at room temperature for 30 minutes, filter for decarburization, and then fine filter with a 0.22 μm microporous membrane to obtain omeprazole sodium...

example 3

[0046] raw material:

[0047] Omeprazole Sodium 30g

[0048] Dextran 100g

[0049] Dextran 40 20g

[0050] Sodium sulfite 40g

[0051] Polymethylmethacrylate 200g

[0052] Mannitol 300g.

[0053] Preparation Process

[0054] (1) Take by weighing 30g omeprazole sodium, 100g dextran and 20g dextran 40, add 2000ml of water for injection to dissolve, adjust the pH value to 2.2 with the hydrochloric acid solution of 1mol / L, stir;

[0055] (2) Slowly add 200g polymethyl methacrylate under electromagnetic stirring, continue stirring for 3 hours at room temperature, add 30g sodium sulfite, continue stirring for 3 hours, adjust the pH value to 10 with 1mol / L sodium hydroxide solution, stir Uniform;

[0056] (3) Add 300 g of mannitol, stir to dissolve, then add 0.2% of the total volume of the solution with charcoal for needles, stir at room temperature for 20 minutes, filter for decarburization, and then fine filter with a 0.22 μm microporous membrane to obtain omeprazole sodium na...

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PUM

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Abstract

The invention discloses an omeprazole sodium freeze-dried preparation used for injection, which is made by the raw materials with the following parts by weight: 20-40 parts of omeprazole sodium, 20-200 parts of glucan, 5-60 parts of stabilizing agent, 5-40 parts of sodium sulfite, 40-400 parts of polymethylmethacrylate and 10-500 parts of freeze-dried skeleton agent. The invention also discloses a preparation method of the omeprazole sodium freeze-dried preparation. When in the processing of forming emulsion and polymerized curing nanoparticles, the preparation causes the medicine to be wrapped into the nanoparticles or absorbed on the surface of the nanoparticles, thus greatly improving the stability of the omeprazole sodium and ensuring the quality of the products.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a freeze-dried preparation of omeprazole sodium for injection and a preparation method thereof. Background technique [0002] Omeprazole sodium, chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl}- 1H-benzimidazole sodium salt. Omeprazole sodium is a weakly alkaline substance, a proton pump inhibitor of gastric parietal cells, which can specifically inhibit the release of H on the secretory microtubules formed by the apical membrane of the parietal cells and the tubular vesicles in the cytoplasm. + +K + -ATPase, thus effectively inhibiting the secretion of gastric acid. [0003] Omeprazole Sodium for Injection is mainly used for peptic ulcer bleeding and anastomotic ulcer bleeding; acute gastric mucosal damage complicated by stress and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs; it is also commonly used to prevent severe Di...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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