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Lansoprazole freeze-dried powder injection and preparation method thereof

A technology of lansoprazole and lyophilized powder, applied in the field of biomedicine, can solve problems such as insufficient formation of excipients, incomplete appearance and the like

Active Publication Date: 2014-04-09
SHANDONG BOMAIKANG PHARMA RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reason analysis may be that the amount of lyophilized powder is too small, resulting in the sublimation process excipients not fully forming a good supporting framework, resulting in an unfulfilled appearance

Method used

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  • Lansoprazole freeze-dried powder injection and preparation method thereof
  • Lansoprazole freeze-dried powder injection and preparation method thereof
  • Lansoprazole freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Ordinary method prepares lansoprazole freeze-dried powder injection (30mg specification)

[0030] prescription

[0031]

[0032] Preparation method: Weigh the prescription amount of raw and auxiliary materials and put them in a medicine barrel, add the prescription amount of water for injection cooled to below 30°C, stir to dissolve completely, add sodium hydroxide to adjust the pH of the liquid medicine to 11.5, add 0.1% (w / v) The required amount of activated carbon for needles is stirred and adsorbed at room temperature for 15 minutes, filtered for decarbonization, sterilized and filtered with a 0.22 μm microporous membrane, the pH and content of the semi-finished product are tested, filled, put into a freeze dryer, and freeze-dried.

[0033] Pre-freezing: first lower the temperature of the lyophilizer plate to below -30°C, and keep it warm for 1h to 2h; freeze-drying: turn on the vacuum pump to evacuate to 0.02MPa, cool the hydrazine to below -50°C, and start lyop...

Embodiment 2

[0035] prescription

[0036]

[0037]Preparation method: Weigh the prescription amount of raw and auxiliary materials and put them in a medicine barrel, add the prescription amount of water for injection cooled to below 30°C, stir to dissolve completely, add sodium hydroxide to adjust the pH of the liquid medicine to 11.5, add 0.1% (w / v) The required amount of activated carbon for needles is stirred and adsorbed at room temperature for 15 minutes, filtered for decarbonization, sterilized and filtered with a 0.22 μm microporous membrane, the pH and content of the semi-finished product are tested, filled, put into a freeze dryer, and freeze-dried.

[0038] Pre-freezing: first lower the temperature of the lyophilizer plate to below -30°C, and keep it warm for 1h to 2h; freeze-drying: turn on the vacuum pump to evacuate to 0.02MPa, cool the hydrazine to below -50°C, and start lyophilization. First, heat up to -15°C at a uniform speed for 3 to 5 hours, and keep at -15°C for 5 to...

Embodiment 3

[0040] prescription

[0041]

[0042] Preparation method: Weigh the prescription amount of raw and auxiliary materials and put them in a medicine barrel, add the prescription amount of water for injection cooled to below 30°C, stir to dissolve completely. Add sodium hydroxide to adjust the pH of the medicinal solution to 11.5, add 0.1% (w / v) activated carbon for needles, stir and adsorb at room temperature for 15 minutes, filter for decarbonization, sterilize and filter with a 0.22 μm microporous membrane, and detect the pH and content of the semi-finished product. Fill it, put it into a freeze dryer, and freeze-dry it.

[0043] Pre-freezing: first lower the temperature of the freeze dryer plate layer to 0°C and keep it warm for 30min-1h; then drop it to -5°C and keep it warm for 30min-1h; then drop it down to -10°C and keep it warm for 30min-1h; ℃~-50℃, keep warm for 1h~2h;

[0044] Freeze-drying: Turn on the vacuum pump to evacuate to 0.02MPa, cool the hydrazine down to...

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Abstract

The invention discloses lansoprazole freeze-dried powder injection which does not contain mannitol. The freeze-dried powder is pre-frozen in a gradually cooling mode, so that lansoprazole, sodium hydroxide and meglumine are eutectic in the pre-freezing process, the freeze-dried powder is redissolved by adding water, the dissolution speed is high, and visible foreign matters and insoluble particles are good.

Description

technical field [0001] The invention belongs to the field of biomedicine and relates to a preparation method of freeze-dried powder injection, more specifically, the invention relates to a preparation method of lansoprazole freeze-dried powder injection. Background technique [0002] Lansoprazole (lansoprazole), its chemical name is: 2-[[(3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl]-sulfinic acid Acyl]-1H-benzimidazole, the structural formula is: [0003] [0004] Lansoprazole was developed by Takeda Corporation of Japan. It is a new generation of proton pump inhibitor anti-ulcer drugs after omeprazole sodium (Omeprazole). It is used for the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis, Zoller-Ellison syndrome (gastrinoma), and has remarkable curative effect, and it also has inhibitory effect on Helicobacter pylori. [0005] Lansoprazole is unstable under acidic conditions, is easily destroyed in gastric acid, and is not easy to be made into co...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/02A61K47/26A61P1/04A61P31/04A61P35/00
Inventor 姜斌谢晓涛李宝玉庞茂平王欢
Owner SHANDONG BOMAIKANG PHARMA RES
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