CN101926799A - Omeprazole sodium medicinal composition for injection and preparation method thereof - Google Patents
Omeprazole sodium medicinal composition for injection and preparation method thereof Download PDFInfo
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- CN101926799A CN101926799A CN2009101155704A CN200910115570A CN101926799A CN 101926799 A CN101926799 A CN 101926799A CN 2009101155704 A CN2009101155704 A CN 2009101155704A CN 200910115570 A CN200910115570 A CN 200910115570A CN 101926799 A CN101926799 A CN 101926799A
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- injection
- omeprazole
- sodium
- omeprazole sodium
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Abstract
The invention provides an omeprazole sodium medicinal composition for injection and a preparation method thereof. The preparation method is characterized by comprising the following steps of: adding raw materials such as omeprazole sodium, ethylene diamine tetraacetic acid, mannitol, sodium sulfite and the like into water for injection to stir and dissolve; adjusting the pH value to be between 10.5 and 10.9; and freezing and drying the mixture to prepare freeze-dried powder injection. The omeprazole sodium freeze-dried powder injection prepared by the method has the advantages of stable characteristics and color, low side effect, high stability and high solubility. The omeprazole sodium content of the omeprazole sodium freeze-dried powder injection prepared by the method is obviously increased compared with that of the common omeprazole sodium injection.
Description
Technical field
The invention belongs to medical technical field, relate generally to a kind of injection omeprazole and receive pharmaceutical composition and preparation method thereof.
Background technology
Omeprazole (Omeprazole, Omep) be Sweden Hassle company in 1979 synthetic first benzimidizole derivatives, be used for the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis, Zollinger-Ellison Syndrome.Can act on the gastric mucosa parietal cell specifically, reduce the H in the parietal cell
+, K
+The activity of-ATP enzyme and the secretion of gastric acid inhibitory.Basal gastric acid secretion and the gastric acid secretion that caused by histamine, pentagastrin, choline, food and vagus nerve stimulation etc. there is strong and persistent inhibitory action.
The domestic existing listing of injection omeprazole sodium, specification is 40mg (in an omeprazole), and its prescription has the 10ml dedicated solvent, and there is inconvenient and allochroic problem in the clinical use in it.
Summary of the invention
Purpose of the present invention just provides a kind of good stability, bland omeprazole sodium medicinal composition for injection.
Composition prescription of the present invention is as follows:
Omeprazole Sodium 15-75 part
Disodiumedetate 0.5-4 part
Mannitol 40-400 part
Sodium sulfite 3-25 part
Preferential prescription of the present invention is as follows:
40 parts of Omeprazole Sodiums
Disodiumedetate 2 minutes
200 parts in mannitol
10 parts of sodium sulfite
Another object of the present invention just provides the preparation method of above-mentioned composition, realizes by following steps:
(1) take by weighing mannitol, disodiumedetate and the sodium sulfite of recipe quantity, the water for injection that adds cumulative volume 80% stirs it is dissolved fully, adds the Omeprazole Sodium of recipe quantity again, stirs it is dissolved fully;
(2) medicinal charcoal of adding cumulative volume 0.1-0.5% (g/ml), stirring and adsorbing 20-30 minute, filter decarburization, add sodium hydroxide and transfer pH value 10.5-10.9, benefit adds to the full amount of water for injection, and stirs, and with 0.22 μ m microporous filter membrane fine straining, gets sterile solution;
(3) with the sterile solution fill in antibiotic glass bottle;
(4) lyophilization: the quick pre-freeze 1.5～3.0 hours of freeze drying box of putting into-40 ℃～-50 ℃, open vacuum pump then, vacuum drying is 10～15 hours between-40 ℃～-15 ℃, the final drying distillation, vacuum drying is 5～10 hours between-15 ℃～-30 ℃, promptly gets goal object.
Adopt the prepared omeprazole freeze-dried powder injection of the present invention, product character color and luster is stable, and it is little that it has side effect, good stability, the advantage that solubility is good.The also more common omeprazole sodium injection of content of the omeprazole freeze-dried powder injection of the inventive method preparation is significantly improved.
Claims (3)
1. omeprazole sodium medicinal composition for injection is characterized in that by following consumption being that the preparation of raw material of weight portion forms:
Omeprazole Sodium 15-75 part
Disodiumedetate 0.5-4 part
Mannitol 40-400 part
Sodium sulfite 3-25 part.
2. pharmaceutical composition according to claim 1 is characterized in that the above-mentioned raw materials weight portion consists of:
40 parts of Omeprazole Sodiums
Disodiumedetate 2 minutes
200 parts in mannitol
10 parts of sodium sulfite.
3. preparation of drug combination method according to claim 1 and 2 is characterized in that realizing by following steps:
(1) take by weighing mannitol, disodiumedetate and the sodium sulfite of recipe quantity, the water for injection that adds cumulative volume 80% stirs it is dissolved fully, adds the Omeprazole Sodium of recipe quantity again, stirs it is dissolved fully;
(2) medicinal charcoal of adding cumulative volume 0.1-0.5% (g/ml), stirring and adsorbing 20-30 minute, filter decarburization, add sodium hydroxide and transfer to pH value 10.5-10.9, benefit adds to the full amount of water for injection, and stirs, and with 0.22 μ m microporous filter membrane fine straining, gets sterile solution;
(3) with the sterile solution fill in antibiotic glass bottle;
(4) lyophilization: the quick pre-freeze 1.5～3.0 hours of freeze drying box of putting into-40 ℃～-50 ℃, open vacuum pump then, vacuum drying is 10～15 hours between-40 ℃～-15 ℃, the final drying distillation, vacuum drying is 5～10 hours between-15 ℃～-30 ℃, promptly gets goal object.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101155704A CN101926799A (en) | 2009-06-18 | 2009-06-18 | Omeprazole sodium medicinal composition for injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101155704A CN101926799A (en) | 2009-06-18 | 2009-06-18 | Omeprazole sodium medicinal composition for injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101926799A true CN101926799A (en) | 2010-12-29 |
Family
ID=43366404
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009101155704A Pending CN101926799A (en) | 2009-06-18 | 2009-06-18 | Omeprazole sodium medicinal composition for injection and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN101926799A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104666188A (en) * | 2015-03-16 | 2015-06-03 | 湖南御家化妆品制造有限公司 | Mint essence oil lipid particle, as well as preparation method and application thereof |
| CN104840433A (en) * | 2014-12-23 | 2015-08-19 | 贵州景峰注射剂有限公司 | Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection |
| CN111904937A (en) * | 2020-09-18 | 2020-11-10 | 开封康诺药业有限公司 | Omeprazole sodium freeze-dried powder injection for injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998593A (en) * | 2006-01-12 | 2007-07-18 | 黄玉明 | Stable omeprazol sodium preparation for injection |
| CN101283986A (en) * | 2008-06-03 | 2008-10-15 | 海南瑞基药物研究有限公司 | Omeprazole freeze-dried powder injection and preparation method thereof |
-
2009
- 2009-06-18 CN CN2009101155704A patent/CN101926799A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998593A (en) * | 2006-01-12 | 2007-07-18 | 黄玉明 | Stable omeprazol sodium preparation for injection |
| CN101283986A (en) * | 2008-06-03 | 2008-10-15 | 海南瑞基药物研究有限公司 | Omeprazole freeze-dried powder injection and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104840433A (en) * | 2014-12-23 | 2015-08-19 | 贵州景峰注射剂有限公司 | Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection |
| CN104666188A (en) * | 2015-03-16 | 2015-06-03 | 湖南御家化妆品制造有限公司 | Mint essence oil lipid particle, as well as preparation method and application thereof |
| CN111904937A (en) * | 2020-09-18 | 2020-11-10 | 开封康诺药业有限公司 | Omeprazole sodium freeze-dried powder injection for injection and preparation method thereof |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20101229 |