Esomeprazole sodium freeze-dried preparation and preparation method thereof

A technology for esomeprazole sodium and freeze-dried preparations, applied in the field of medicine, can solve problems such as blood calcium reduction, calcium ion reduction, personal safety impact, etc., and achieve the effects of reducing water content, not easy to shrink, and improving production efficiency

Active Publication Date: 2014-01-08
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, as we all know, because edetic acid and its salts can combine with calcium ions in the human body to form soluble complexes, which will cause the decrease of calcium ions in the body, lead to a decrease in blood calcium, and affect personal safety. When edetic acid and its salts are used as antioxidants for injections, the management is relatively strict, and the dosage is also strictly controlled

Method used

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  • Esomeprazole sodium freeze-dried preparation and preparation method thereof
  • Esomeprazole sodium freeze-dried preparation and preparation method thereof
  • Esomeprazole sodium freeze-dried preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038]

[0039] Specific steps:

[0040] Weigh each raw and auxiliary material in the prescription amount in the weighing room, and set aside.

[0041] Take 60% of the prescribed amount of fresh water for injection, let it cool to 30°C±5°C, and add the prescribed amount of histidine.

[0042] After adding the esomeprazole sodium of recipe quantity in above-mentioned solution and dissolving completely, set aside.

[0043] While stirring, add 0.5 mol / L sodium hydroxide solution to adjust the pH value of the medicinal solution within the range of 11.0-12.0.

[0044] Dilute the mixed solution to the mark with the remaining prescribed amount of water for injection (cooled to 30°C ± 5°C).

[0045] Add the specified concentration of medicinal activated carbon (unit: W / V, 0.03%), stir and absorb for 15 minutes, decarbonize and filter with 0.45um filter membrane, sterilize and filter with 0.22um filter element, measure the intermediate solution, and fill;

[0046] Freeze-drying p...

Embodiment 2

[0052]

[0053] Specific steps:

[0054] Weigh each raw and auxiliary material in the prescription amount in the weighing room, and set aside.

[0055] Take 60% of the prescribed amount of fresh water for injection, let it cool to 30°C±5°C, and add the prescribed amount of lysine.

[0056] After adding the esomeprazole sodium of recipe quantity in above-mentioned solution and dissolving completely, set aside.

[0057] While stirring, add 0.5 mol / L sodium hydroxide solution to adjust the pH value of the medicinal solution within the range of 11.0-12.0.

[0058] Dilute the mixed solution to the mark with the remaining prescribed amount of water for injection (cooled to 30°C ± 5°C).

[0059] Add the specified concentration of medicinal activated carbon (unit: W / V, 0.03%), stir and absorb for 15 minutes, decarbonize and filter with 0.45um filter membrane, sterilize and filter with 0.22um filter element, measure the intermediate solution, and fill;

[0060] Freeze-drying proc...

Embodiment 3

[0066]

[0067] Specific steps:

[0068] Weigh each raw and auxiliary material in the prescription amount in the weighing room, and set aside.

[0069] Take 60% of the prescribed amount of fresh water for injection, let it cool to 30°C±5°C, and add the prescribed amount of arginine.

[0070] After adding the esomeprazole sodium of recipe quantity in above-mentioned solution and dissolving completely, set aside.

[0071] While stirring, add 0.5 mol / L sodium hydroxide solution to adjust the pH value of the medicinal solution within the range of 11.0-12.0.

[0072] Dilute the mixed solution to the mark with the remaining prescribed amount of water for injection (cooled to 30°C ± 5°C).

[0073] Add the specified concentration of medicinal activated carbon (unit: W / V, 0.03%), stir and absorb for 15 minutes, decarbonize and filter with 0.45um filter membrane, sterilize and filter with 0.22um filter element, measure the intermediate solution, and fill;

[0074] Freeze-drying pr...

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Abstract

The invention discloses an esomeprazole sodium freeze-dried preparation prepared by freeze-drying a liquid medicine which is prepared by dissolving esomeprazole sodium, alkaline amino acid and sodium hydroxide in water for injection, wherein the contents by mass volume ratio of the someprazole sodium, the alkaline amino acid and the sodium hydroxide are as follows: 20 mg/ml of the someprazole solidum, 0.5-5 mg/ml of the alkaline amino acid and the sodium hydroxide which adjusts the pH value of the liquid medicine within 11.0-12.0. As the alkaline amino acid is adopted as a stabilizing agent, amino bond existing in the alkaline amino acid can improve stability of the esomeprazole sodium in the processes of dissolution, freeze-drying, and storage. However, as alkaline amino acid is essential amino acid for a human body, the disclosed esomeprazole sodium freeze-dried preparation has higher safety in comparison with the existing esomeprazole sodium freeze-dried preparations which almost adopt edetic acid and salts of edetic acid as the stabilizing agent.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a freeze-dried preparation of esomeprazole sodium and a preparation method thereof. Background technique [0002] Esomeprazole sodium, chemical name: S-5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl-1H - sodium benzimidazole. The structure is as follows: [0003] [0004] Esomeprazole is the S-isomer of omeprazole, which reduces gastric acid secretion through a specific targeting mechanism and is a specific inhibitor of proton pumps in parietal cells. The site and mechanism of action are that esomeprazole concentrates in the high-acid environment of the acid-secreting microtubules of the parietal cells and converts it into an active form, thereby inhibiting the H+ / k+-ATP (proton pump) at this site, and affecting the basic gastric acid secretion and Stimulated gastric acid secretion is inhibited. [0005] Esomeprazole sodium is the first proton pump inhibitor develop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
Inventor 王丽云陈洁冯超敏戴兴祥
Owner ZHEJIANG YATAI PHARMA
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