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Omeprazole sodium pharmaceutical composition

A technology of omeprazole sodium and composition, applied in the field of omeprazole sodium pharmaceutical composition, can solve the problems of poor water solubility, preparation stability difficult to achieve long-term stable storage and the like

Active Publication Date: 2015-12-23
CHONGQING PHARSCIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that omeprazole has poor water solubility, but it is easily soluble in water when it forms a salt under alkaline conditions.
Therefore, when omeprazole sodium is made into injection preparations, it is necessary to strengthen the control of alkalinity, usually pH9-11, usually also need to add other auxiliary materials in order to improve the stability of the preparation, but the stability of the obtained preparation is still difficult to achieve long-term stable storage requirements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 omeprazole sodium pharmaceutical composition (freeze-dried powder injection)

[0021] prescription:

[0022]

[0023] Preparation Process:

[0024] 1) Add phosphate buffer to water for injection to make the pH of the solution 7.5-7.9;

[0025] 2) Under the condition of blowing nitrogen, add imipenem and cilastatin sodium to the solution in the previous step, dissolve and clarify, then add sorbitol, mix well, add omeprazole sodium, and stir at the same time to obtain a clear solution;

[0026] 3) Use pH regulator sodium hydroxide solution or hydrochloric acid to adjust the pH value of the clear solution to 7.5-7.9, add water for injection to a sufficient amount of 5000ml, filter with a 0.2μm filter membrane, fill it into 1000 bottles of ampoule, and place it in a freeze dryer Freeze-drying in medium temperature, cool the vial to -40°C, then rise to -25°C, dry in vacuum, then raise the temperature to 5°C, after about half an hour, the temperature rises t...

Embodiment 2

[0027] Embodiment 2 omeprazole sodium pharmaceutical composition (freeze-dried powder injection)

[0028] prescription:

[0029]

[0030] Preparation Process:

[0031] 1) Add phosphate buffer to water for injection to make the pH of the solution 7.5-7.9;

[0032] 2) Under the condition of blowing nitrogen, add imipenem and cilastatin sodium to the solution in the previous step, dissolve and clarify, then add sorbitol, mix well, add omeprazole sodium, and stir at the same time to obtain a clear solution;

[0033] 3) Adjust the pH value of the clear solution to 7.5-7.9 with pH regulator sodium hydroxide solution, add water for injection to a sufficient amount of 10000ml, filter with a 0.2μm filter membrane, fill it into 1000 bottles of ampoule, and freeze it in a freeze dryer For drying, cool the vial to -40°C, then raise it to -25°C, dry it in vacuum, then raise the temperature to 5°C, and after about half an hour, the temperature rises to 10°C, and continue drying for 1-2...

Embodiment 3

[0034] Embodiment 3 stability test

[0035] Take 5 samples of the freeze-dried powder injection of Implementation 1 and place them at 40°C for 2 weeks, dissolve them in water for injection, and measure the content of omeprazole. At the same time, take another 5 samples and store them at room temperature for 24 months. Day, 1 month, 5 months, 12 months and 24 months of omeprazole content (measured after dissolving with physiological saline), the assay method is conventional HPLC. The results are shown in Table 1.

[0036] Table 1 chemical stability test result, omeprazole content

[0037] sample

[0038]

[0039] Results: The appearance of 5 samples was powdery or lumpy, and no collapse occurred. The results in Table 1 show that the chemical properties of the omeprazole sodium pharmaceutical composition (lyophilized powder injection) of the present invention are exceptionally stable. The sample of Example 2 has the same stability as the sample of Example ...

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Abstract

The invention discloses an Omeprazole sodium pharmaceutical composition containing Omeprazole sodium, Imipenem and Cilastatin sodium. According to the composition, the treatment effect of Omeprazole can be improved, and Omeprazole sodium is unusually stable in the absence of antioxidants and metal chelating agents.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a pharmaceutical composition of omeprazole sodium and a preparation method thereof. Background technique [0002] Digestive system disease is a common and frequently-occurring disease, and it is also a chronic disease that easily recurs. Statistical analysis shows that the incidence of digestive system disease in the world accounts for 10-12% of human beings, and the incidence rate of digestive system diseases in cities and towns in my country is 11.43%. Bacillus is the pathogenic cause of gastritis and gastric ulcer. Patients with gastric ulcer are often accompanied by pylori infection, and the curative methods are limited at present. [0003] Proton pump inhibitors (PPIs for short) have opened up a new way of action for anti-peptic ulcer drugs. The first-generation product, omeprazole, was synthesized in 1979 and launched in Switzerland in 1988. Its acid-suppressing effect i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/19A61P1/04A61P31/04A61K31/198A61K31/407
Inventor 游洪涛刘小英沈浩王茂张壹王道权
Owner CHONGQING PHARSCIN PHARM CO LTD
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