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Esmeprazole sodium freeze-dried powder injection and preparation method thereof

A technology of esomeprazole sodium and freeze-dried powder injection, which is applied in the field of esomeprazole sodium freeze-dried powder injection and its preparation, and can solve the problem of short storage time of infusion solution, affecting drug quality and safety, and poor stability and other problems, to achieve the effect of stable color and luster, quality assurance and safety, and good stability

Pending Publication Date: 2020-12-01
开封康诺药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Esomeprazole sodium raw material is sensitive to high temperature, has poor stability, and is prone to degradation under high temperature, oxidation and light conditions, resulting in impurities that may affect the quality and safety of the drug
Therefore, esomeprazole sodium is usually prepared as a freeze-dried powder injection, but we found that even if it is prepared as a freeze-dried preparation, if the temperature is too high during the transportation and storage of this variety, the related substances of the preparation will still be released. Significantly increased, and the storage time of the prepared infusion solution in clinical use is shorter

Method used

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  • Esmeprazole sodium freeze-dried powder injection and preparation method thereof
  • Esmeprazole sodium freeze-dried powder injection and preparation method thereof
  • Esmeprazole sodium freeze-dried powder injection and preparation method thereof

Examples

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Embodiment 1

[0020] Prescription for 20mg esomeprazole sodium freeze-dried powder injection: esomeprazole sodium 20.0mg, edetate disodium 1.5mg, sodium sulfite 0.04mg, adjust pH to 11.2 with sodium hydroxide, water for injection Add to 1ml.

[0021] Concrete preparation process is as follows:

[0022] Dosing: Prepare 1mol / L sodium hydroxide solution in advance. Nitrogen protection is carried out by nitrogen filling. Take about 70% of the prescribed amount of water for injection (25°C), add the prescribed amount of disodium edetate and stir to dissolve it. After the water for injection is cooled to 20°C, add sodium sulfite, and finally add the prescribed amount. The esomeprazole sodium, after stirring and dissolving, adjust the pH value to 11.2 with 1mol / L sodium hydroxide solution, and finally add water for injection.

[0023] Filtration: The medicinal liquid is pre-filtered through a 0.45 μm (PES) microporous filter, and then sterilized and filtered through a 0.22 μm (PES) microporous f...

Embodiment 2

[0028] Prescription for 40mg esomeprazole sodium freeze-dried powder injection: esomeprazole sodium 40.0mg, edetate disodium 1.5mg, sodium sulfite 0.04mg, adjust pH to 11.2 with sodium hydroxide, water for injection Add to 1ml.

[0029] Concrete preparation process is as follows:

[0030] Dosing: Prepare 1mol / L sodium hydroxide solution in advance. Nitrogen protection is carried out by nitrogen filling. Take about 70% of the prescribed amount of water for injection (25°C), add the prescribed amount of disodium edetate and stir to dissolve it. After the water for injection is cooled to 20°C, add sodium sulfite, and finally add the prescribed amount. The esomeprazole sodium, after stirring and dissolving, adjust the pH value to 11.2 with 1mol / L sodium hydroxide solution, and finally add water for injection.

[0031] Filtration: The medicinal liquid is pre-filtered through a 0.45 μm (PES) microporous filter, and then sterilized and filtered through a 0.22 μm (PES) microporous f...

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Abstract

The invention discloses an esmeprazole sodium freeze-dried powder injection and a preparation method thereof, and relates to the technical field of biological medicines, the esmeprazole sodium freeze-dried powder injection comprises esmeprazole sodium, edetate disodium and sodium sulfite, and the pH value of the freeze-dried stock solution of the freeze-dried powder injection is 11.0-11.5. The esomeprazole sodium freeze-dried powder injection prepared by the preparation method disclosed by the invention is stable in character and color, good in stability and good in resolubility, and the quality and safety of clinical medication are guaranteed.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a freeze-dried powder injection of esomeprazole sodium and a preparation method thereof. Background technique [0002] Esomeprazole sodium is a proton pump inhibitor, English name: Esomeprazole Sodium, chemical name: 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl -2-pyridyl)methyl]sulfinyl]-1H-benzimidazole sodium salt, molecular formula: C 17 h 18 N 3 o 3 SNa, molecular weight: 367.40, structural formula: [0003] [0004] Esomeprazole sodium is commonly used in the treatment of patients with gastroesophageal reflux disease and patients with acute gastric or duodenal ulcer bleeding. [0005] Esomeprazole sodium API is sensitive to high temperature, has poor stability, and is prone to degradation under high temperature, oxidation and light conditions, resulting in impurities that may affect the quality and safety of the drug. Therefore, esomeprazole sodium is usually prep...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/02A61K47/18A61P1/04
CPCA61K9/19A61K9/0019A61K31/4439A61K47/183A61K47/02A61P1/04
Inventor 王康林周多玲廖华宁陶杰王磊
Owner 开封康诺药业有限公司
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