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New application of injection omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma

A technology of omeprazole sodium and lymphoid tissue is applied in the direction of making medicines into special physical or taking forms of devices, medicine combinations, medical preparations containing active ingredients, etc., which can solve the problem of insufficient stability of preparations and clear solutions It can solve the problems of poor degree and easy cross-contamination, and achieve good stability and resolubility, good social benefits, and good stability.

Inactive Publication Date: 2010-01-27
邓菊娟
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Omeprazole sodium has poor stability and is sensitive to light, heat, oxygen, water, etc. Therefore, the preparation of stable omeprazole sodium preparations for injection has always been a difficulty in the development of omeprazole sodium preparations
The omeprazole sodium for injection disclosed in the prior art is equipped with a special solvent, which has the problems of inconvenient clinical use and easy cross-contamination
CN101229133A discloses a kind of omeprazole sodium freeze-dried powder injection and preparation method thereof, adopts sodium citrate as metal ion chelating agent and pH adjusting agent, although preparation process is simple, auxiliary material consumption is few, but preparation stability is still insufficient, compound The clarity of the dissolved solution is poor, and the pH value changes greatly, which is not suitable for clinical application
CN101283986A discloses a freeze-dried powder injection of omeprazole sodium and a preparation method thereof. The product has good stability and resolubility, but a relatively large amount of cyclodextrin stabilizer is used in the preparation, which affects product safety, and the main drug omeprazole The content of azole sodium is still not high enough, which will affect the production cost and clinical application

Method used

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  • New application of injection omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma
  • New application of injection omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma
  • New application of injection omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prescription composition:

[0021] Omeprazole sodium (calculated as omeprazole) 40g

[0022] Mannitol 80g

[0023] Edetate Calcium Sodium 0.4g

[0024] Sodium sulfite 0.8g

[0025] Add water for injection to 2000ml

[0026] Makes 1000 bottles

[0027] Preparation:

[0028] 1) Take bulk drug (in terms of omeprazole) and corresponding adjuvants by prescription quantity, add filler, metal ion complexing agent, antioxidant to the sterile water for injection of 80% of dosing volume, stir to dissolve and replenish Add sterile water for injection to the full amount, measure the pH value of the solution, and adjust the pH value to 10.7 with 1.0 mol / L sodium hydroxide.

[0029] 2) Add activated carbon for needles with a dosing volume of 0.1%, heat and stir for 15 minutes, filter for decarburization, and fine filter with a 0.2 μm microporous membrane to obtain a sterile solution.

[0030] 3) Fill the medicinal solution in an antibiotic glass bottle.

[0031] 4) Put the sa...

Embodiment 2

[0034] Prescription composition:

[0035] Omeprazole sodium (calculated as omeprazole) 40g

[0036] Dextran 120g

[0037] Edetate Calcium Sodium 1.2g

[0038] Sodium metabisulfite 2.4g

[0039] Add water for injection to 2000ml

[0040] Makes 1000 bottles

[0041] Preparation:

[0042]1) Take bulk drug (in terms of omeprazole) and corresponding adjuvants by prescription quantity, add filler, metal ion complexing agent, antioxidant to the sterile water for injection of 80% of dosing volume, stir to dissolve and replenish Add sterile water for injection to the full amount, measure the pH value of the solution, adjust the pH value to 11.0 with 1.0mol / L sodium hydroxide.

[0043] 2) Add activated carbon for needles with a dosing volume of 0.1%, heat and stir for 15 minutes, filter for decarburization, and fine filter with a 0.2 μm microporous membrane to obtain a sterile solution.

[0044] 3) Fill the medicinal solution in an antibiotic glass bottle.

[0045] 4) Put the sa...

Embodiment 3

[0048] Prescription composition:

[0049] Omeprazole sodium (calculated as omeprazole) 40g

[0050] Mannitol 160g

[0051] Edetate Disodium 0.8g

[0052] Sodium sulfite 1.6g

[0053] Add water for injection to 2000ml

[0054] Makes 1000 bottles

[0055] Preparation:

[0056] 1) Take bulk drug (in terms of omeprazole) and corresponding adjuvants by prescription quantity, add filler, metal ion complexing agent, antioxidant to the sterile water for injection of 80% of dosing volume, stir to dissolve and replenish Add sterile water for injection to the full amount, measure the pH value of the solution, adjust the pH value to 10.5 with 1.0mol / L sodium hydroxide.

[0057] 2) Add activated carbon for needles with a dosing volume of 0.2%, heat and stir for 15 minutes, filter for decarburization, and fine filter with a 0.2 μm microporous membrane to obtain a sterile solution.

[0058] 3) Fill the medicinal solution in an antibiotic glass bottle.

[0059] 4) Put the sample into ...

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Abstract

The invention relates to new application of injection omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma. The injection omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma comprises omeprazole sodium, filling agent, metallic ion complexing agent, antioxidant and pH regulator. The invention has the advantages of stable characters and color, little side effects, high security, good stability and favorable resolubility, and has higher content of omeprazole sodium than that of the common omeprazole sodium injection.

Description

technical field [0001] The invention relates to a medicine for injecting omeprazole sodium for treating gastric mucosa-associated lymphoid tissue lymphoma, in particular to a preparation of omeprazole sodium for injection which can be used for treating gastric mucosa-associated lymphoid tissue lymphoma and its preparation method. Background technique [0002] The occurrence of mucosa-associated lymphoid tissue (MALT) lymphoma is related to Helicobacter pylori infection. Since Wother spoon. Gastric lymphoma of mucosa associated lymphoid tissue and Helicobacter pylori[J]Annu. ): 289-299. After the first report that the use of antibiotics to eradicate Helicobacter pylori caused MALT lymphoma to regress and regress, the relationship between gastric MALT lymphoma and Helicobacter pylori was further established. There is usually no normal lymphoid tissue in the sites where MALT lymphoma occurs, but infection with Helicobacter pylori can cause MALT to be produced in these sites, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61P1/00A61J3/00A61K9/19
Inventor 邓菊娟
Owner 邓菊娟
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