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Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof

A technology of rabeprazole sodium and freeze-dried powder injection, which is applied in the direction of freeze-dried delivery, drug combination, powder delivery, etc., and can solve the problem of many insoluble particles of freeze-dried powder injection, poor resolubility of freeze-dried powder injection, and complicated preparation process and other problems, to achieve the effect of less insoluble particles, good stability and simple process

Active Publication Date: 2012-07-11
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The freeze-dried powder of rabeprazole sodium disclosed in the prior art has various defects, for example, the preparation process is relatively complicated or time-consuming and energy-consuming, or the freeze-dried powder has many insoluble particles in the solution, or the freeze-dried powder The reconstitution of needles in aqueous solution is relatively poor, etc.

Method used

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  • Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof
  • Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof
  • Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037] Rabeprazole sodium composition prescription:

[0038]

[0039] Rabeprazole sodium composition is prepared into the preparation method of rabeprazole sodium powder injection:

[0040] Dissolve the rabeprazole sodium, meglumine, mannitol, sodium sulfite and disodium ethylenediaminetetraacetic acid in the prescribed amount first in water for injection, stir to make it dissolve, and adjust the pH of the solution to 11.5 with disodium hydrogen phosphate; Add 0.1% g / ml activated carbon to the solution prepared above, stir for 15 minutes, filter and decarbonize; cool the filtrate to -42°C, pre-freeze for 2 hours, vacuumize, heat up to 30°C at a rate of 5.5°C / h, and then After heat preservation for 1 hour, the freeze-dried powder of beprazole sodium is obtained.

Embodiment 2

[0042] Rabeprazole sodium composition prescription:

[0043]

[0044] Rabeprazole sodium composition is prepared into the preparation method of rabeprazole sodium powder injection:

[0045] Dissolve the prescribed amount of rabeprazole sodium, meglumine, mannitol, sodium sulfite, disodium ethylenediaminetetraacetic acid in water for injection, stir to dissolve, adjust the pH of the solution to 11.8 with sodium phosphate; Add 0.05% g / ml activated carbon to the solution, stir for 20 minutes, filter and decarbonize; cool the filtrate to -40°C, pre-freeze for 2 hours, vacuumize, heat up to 25°C at a speed of 5.8°C / h, and keep warm for 2 hours, the beprazole sodium freeze-dried powder was obtained.

Embodiment 3

[0047] Rabeprazole sodium composition prescription:

[0048]

[0049] Rabeprazole sodium composition is prepared into the preparation method of rabeprazole sodium powder injection:

[0050]First dissolve the prescribed amount of rabeprazole sodium, meglumine, mannitol, sodium sulfite, and disodium edetate in water for injection, stir to dissolve, and adjust the pH of the solution to 11.2; Add 0.5% g / ml activated carbon, stir for 15 minutes, filter and decarbonize; cool the filtrate to -45°C, pre-freeze for 1 hour, vacuumize, heat up to 27°C at a rate of 5.5°C / h, and keep it warm for 2 hours. The beprazole sodium freeze-dried powder was obtained.

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Abstract

The invention provides a rabeprazole sodium composite, which comprises the following components: rabeprazole sodium parts by weight, meglumine 7.5-8.5 parts by weight, mannitol 100-170 parts by weight, sodium sulfite 9-10 parts by weight and ethylene diamine tetraacetic acid 4.5-5.5 parts by weight. The preparation process of the rabeprazole sodium composite lyophilized injectable powder preparedby the composites is greatly simplified, the lyophilized time of the lyophilized injectable powder is also shortened, production cost is reduced, appearance is full, stability and re-dissolution are good, and insoluble particles of injection solution are few.

Description

technical field [0001] The present invention relates to a rabeprazole sodium composition, in particular to a rabeprazole sodium composition and a preparation method thereof. Background technique [0002] Ulcer disease is a common type of disease, and it is prone to recurrent clinically, often accompanied by serious complications, such as gastric and duodenal ulcers, which can be complicated by upper gastrointestinal bleeding and perforation, which seriously threaten people's health. Proton pump inhibitors are powerful weapons in the fight against ulcer disease. The fourth PPI developed after omeprazole, lansoprazole and pantoprazole is the proton pump inhibitor (Proton Pump Inhibitors, PPI) anti-ulcer drug rabeprazole. [0003] The chemical name of Rabeprazole Sodium is: 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]- 1H-Benzimidazole Sodium. [0004] Chemical Structure: [0005] [0006] Rabeprazole sodium is a new type of proton pump inhibitor, which ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/26A61P1/04
Inventor 郭中明李明华张明法
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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