Stable omeprazol sodium preparation for injection

A technology of omeprazole sodium and omeprazole, applied in the field of medicine, can solve the problems of inconvenient clinical use, easy discoloration and the like

Inactive Publication Date: 2007-07-18
黄玉明
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Omeprazole Sodium for Injection has been marketed in China, the specification is 40mg (calculated as omeprazole), and it is equipped with 10ml of special solvent, which has the problems of inconvenient and easy to change color in clinical use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] prescription:

[0090] Omeprazole sodium (calculated as omeprazole) 40g

[0091] Disodium EDTA 1.5g

[0092] Mannitol 200g

[0093] Add sterile water for injection to 2000ml

[0094]

[0095] A total of 1000 bottles were prepared

[0096] Preparation:

[0097] 1) At first, the production equipment and instruments such as antibiotic glass bottles, rubber stoppers, suction funnels, and filter membranes are aseptically treated;

[0098] 2) Weigh the raw and auxiliary materials according to the prescription amount (feeding after converting omeprazole sodium);

[0099] 3) Add disodium edetate and mannitol into sterile water for injection with a total volume of 80%, and stir until completely dissolved; add 0.1% activated carbon for needles, heat and stir at 80°C for 10 minutes, filter and decarbonize;

[0100] 4) Add the omeprazole sodium of the prescribed amount to the above-mentioned filtrate, stir to dis...

Embodiment 2

[0110] prescription:

[0111] Omeprazole sodium (calculated as omeprazole) 80g

[0112] Disodium edetate 3g

[0113] Mannitol 350g

[0114] Add sterile water for injection to 5000ml

[0115]

[0116] A total of 1000 bottles were prepared

[0117] Preparation:

[0118] 1) At first, the production equipment and instruments such as antibiotic glass bottles, rubber stoppers, suction funnels, and filter membranes are aseptically treated;

[0119] 2) Weigh the raw and auxiliary materials according to the prescription amount (feeding after converting omeprazole sodium);

[0120] 3) Add disodium edetate and mannitol into sterile water for injection with a total volume of 80%, and stir until completely dissolved; add 0.1% activated carbon for needles, heat and stir at 80°C for 10 minutes, filter and decarbonize;

[0121] 4) Add the omeprazole sodium of the prescribed amount to the above-mentioned filtrate, stir to dissol...

Embodiment 3

[0131] prescription:

[0132] Omeprazole sodium (calculated as omeprazole) 20g

[0133] Disodium EDTA 1.0g

[0134] Mannitol 150g

[0135] Add sterile water for injection to 1000ml

[0136]

[0137] A total of 1000 bottles were prepared

[0138] Preparation:

[0139] 1) At first, the production equipment and instruments such as antibiotic glass bottles, rubber stoppers, suction funnels, and filter membranes are aseptically treated;

[0140] 2) Weigh the raw and auxiliary materials according to the prescription amount (feeding after converting omeprazole sodium);

[0141] 3) Add disodium edetate and mannitol into sterile water for injection with a total volume of 80%, and stir until completely dissolved; add 0.1% activated carbon for needles, heat and stir at 80°C for 10 minutes, filter and decarbonize;

[0142] 4) Add the omeprazole sodium of the prescribed amount to the above-mentioned filtrate, stir to dissol...

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PUM

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Abstract

A high-stability freeze-dried powder injection of omeprazole sodium is proportionally prepared from omeprazole sodium, Na2EDTA and mannitol. Its preparing process is also disclosed.

Description

technical field [0001] The invention belongs to the technical field of medicine, and mainly relates to a new stable prescription of omeprazole sodium freeze-dried preparation for injection and a preparation process thereof. Background technique [0002] Omeprazole (Omeprazole, Omep) is a benzimidazole derivative firstly synthesized by Hassle Company in Sweden in 1979, and is used for the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis, and Zoller-Ellison syndrome. It can specifically act on the parietal cells of the gastric mucosa and reduce the H in the parietal cells + , K + -ATPase activity to inhibit gastric acid secretion. It has a strong and long-lasting inhibitory effect on basic gastric acid secretion and gastric acid secretion caused by histamine, pentagastrin, choline, food and stimulation of the vagus nerve. [0003] Omeprazole Sodium for Injection has been listed domestically, the specification is 40mg (calculated as omeprazole), and it is equip...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/08A61P1/04
Inventor 黄玉明
Owner 黄玉明
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