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Omeprazole sodium for injection and preparation method thereof

A technology for omeprazole sodium and injection, applied in the field of preparation of sterile powder injection, can solve the problems of polymerization, discoloration, impurity polymerization, discoloration, etc., and achieve the effects of improving plumpness, improving looseness, and reducing the generation of impurities

Active Publication Date: 2022-02-11
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] From the structural formula of omeprazole sodium, it can be seen that the structural formula of omeprazole sodium has the chemical structure of sulfonyl benzoimidazole, and the structure of sulfonyl benzoimidazole is easily affected by various factors such as pH value and heavy metal ions. Aggregation, discoloration, etc. occur, which leads to the occurrence of impurities in omeprazole sodium during the preparation, storage, and use of polymerization, discoloration, etc. Reaction has always been the focus of research in the process of omeprazole sodium preparation

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 A kind of preparation method of omeprazole sodium for injection

[0035] Present embodiment is a kind of preparation method of omeprazole sodium for injection, and concrete preparation process comprises the following steps of carrying out successively:

[0036] Take water for injection, boil it and let it cool for later use;

[0037] Take 199.63g glycine and add water for injection to prepare 13.3L glycine aqueous solution, which is 1mol / L glycine aqueous solution;

[0038] Take 144.18g of disodium hydrogen phosphate (dihydrate) and add water for injection to prepare 16.2L of disodium hydrogen phosphate aqueous solution, which is 0.2mol / L disodium hydrogen phosphate aqueous solution;

[0039] Take 82g of sodium hydroxide and add water for injection to prepare 20.5L of sodium hydroxide aqueous solution, which is 0.1mol / L sodium hydroxide aqueous solution.

[0040] Take glycine aqueous solution, disodium hydrogen phosphate aqueous solution and sodium hydrox...

Embodiment 2～6

[0050] The preparation method of embodiment 2~6 injection omeprazole sodium

[0051] Embodiments 2 to 6 are respectively a preparation method of omeprazole sodium for injection, and their steps are basically the same as in Example 1, the difference is only in the amount of raw materials and process parameters, see Table 1 for details:

[0052] List of each technological parameter in table 1 embodiment 2~6

[0053]

[0054]

[0055] The content of the other parts of Examples 2-6 is the same as that of Example 1.

[0056] The omeprazole sodium for injection prepared in Examples 2-6 has good stability, high main drug content, less impurities and excellent resolubility.

experiment example 1

[0057] Performance measurement of experimental example 1 omeprazole sodium for injection

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Abstract

The invention provides omeprazole sodium for injection and a preparation method thereof, and belongs to the technical field of medicine preparation. The preparation method comprises the steps that 0.01-0.02 part by weight of antioxidant is taken to be dissolved in a glycine-disodium hydrogen phosphate-sodium hydroxide buffer solution with the pH value being 10.1-11.1, then 1 part by weight of omeprazole sodium is added to be dissolved, then decoloration, degerming filtration and freeze-drying are conducted to obtain the omeprazole sodium for injection. Aiming at the structural characteristics of the omeprazole sodium, the glycine-disodium hydrogen phosphate-sodium hydroxide buffer solution with a specific pH value is prepared, so that polymerization reaction of the omeprazole sodium caused by the influence of the pH value in the preparation, storage and use processes is effectively inhibited, the impurity generation of the omeprazole sodium is effectively reduced, and the stability of the omeprazole sodium for injection is improved.

Description

technical field [0001] The invention relates to the preparation of sterile powder injections, in particular to a kind of omeprazole sodium for injection and a preparation method thereof. Background technique [0002] Omeprazole sodium is a drug for the treatment of peptic ulcer disease. It is a synthetic proton pump inhibitor of phenylimidazole class. Its chemical name is 5-methoxy 2-{[[(4-methoxy-3 ,5,-Dimethyl-2-pyridyl)-methyl]sulfinyl}-1H-benzimidazole sodium, whose parent compound omeprazole reduces gastric acid secretion by specific effect on parietal cell proton pump , the principle is that omeprazole aggregates in the acidic environment of the parietal cells and converts it into an active form, selectively inhibiting H + -K + -ATPase activity, thereby reducing gastric acid secretion, for the treatment of duodenal ulcer, Zol-Elson's disease, gastric ulcer and reflux esophagitis, etc. [0003] The chemical structural formula of omeprazole sodium is: [0004] [...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/18A61K47/02A61K31/4439A61P1/04
CPCA61K9/0019A61K9/19A61K47/183A61K47/02A61K31/4439A61P1/04
Inventor 陈益智史江永郑朝武陈雪君
Owner HAINAN HUALON PHARM
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