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A kind of rabeprazole sodium preparation for injection and preparation method thereof

A technology for rabeprazole sodium and injection, which is applied in the field of preparation of rabeprazole sodium for injection and its preparation, can solve the problems of complex preparation process, poor stability, and many types of excipients, and achieve improved heat transfer rate and improved Stable, full-looking effect

Active Publication Date: 2019-06-14
WUHAN LEADPHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is: the stability of rabeprazole sodium for injection in the prior art is poor, there are many types of auxiliary materials, and the preparation process is comparatively complicated

Method used

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  • A kind of rabeprazole sodium preparation for injection and preparation method thereof
  • A kind of rabeprazole sodium preparation for injection and preparation method thereof
  • A kind of rabeprazole sodium preparation for injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0037] 1. The formula of the rabeprazole sodium preparation for injection of the present embodiment (1000 bottles):

[0038] Rabeprazole sodium 20g;

[0039] Mannitol 50g;

[0040] Arginine 1g;

[0041] Sodium hydroxide 1g.

[0042] 2. Preparation process

[0043] (1) Take 1600mL of water for injection at room temperature, add the prescribed amount of mannitol, arginine and sodium hydroxide, the pH is 11.5, stir to dissolve, add rabeprazole sodium, stir to dissolve, then add water for injection to For the full amount, add 0.05% activated carbon, stir for 30 minutes, and decarbonize. Filter with a 0.22μm microporous membrane, dispense into vials, and half-fill with rubber stoppers.

[0044] (2) Cool down to -40°C, pre-freeze for 2 hours; start vacuuming, raise the temperature of the product to 5°C, keep it warm for 18 hours, slowly raise the temperature to 25°C, keep it warm for 3 hours, press the plug, and cover it.

Embodiment 2

[0046] 1. The formula of the rabeprazole sodium preparation for injection of the present embodiment (1000 bottles):

[0047] Rabeprazole sodium 20g;

[0048] Mannitol 50g;

[0049] Arginine 5g;

[0050] Sodium hydroxide 1g.

[0051] 2. Preparation process

[0052] (1) Take 1600mL of water for injection at room temperature, add the prescribed amount of mannitol, arginine and sodium hydroxide, the pH is 11.5, stir to dissolve, add rabeprazole sodium, stir to dissolve, then add water for injection to For the full amount, add 0.05% activated carbon, stir for 30 minutes, and decarbonize. Filter with a 0.22μm microporous membrane, dispense into vials, and half-fill with rubber stoppers.

[0053] (2) Cool down to -40°C, pre-freeze for 2 hours; start vacuuming, raise the temperature of the product to 5°C, keep it warm for 18 hours, slowly raise the temperature to 25°C, keep it warm for 3 hours, press the plug, and cover it.

Embodiment 3

[0055] 1. The formula of the rabeprazole sodium preparation for injection of the present embodiment (1000 bottles):

[0056] Rabeprazole sodium 20g;

[0057] Mannitol 50g;

[0058] Arginine 10g;

[0059] Sodium hydroxide 1g.

[0060] 2. Preparation process

[0061] (1) Take 1600mL of water for injection at room temperature, add the prescribed amount of mannitol, arginine and sodium hydroxide, stir to dissolve, add rabeprazole sodium, stir to dissolve, add water for injection to the full amount, add 0.05 % activated carbon, stirred for 30 minutes, decarbonized. Filter with a 0.22μm microporous membrane, divide into vials, and half-fill with rubber stoppers.

[0062] (2) Cool down to -40°C, pre-freeze for 2 hours; start vacuuming, raise the temperature of the product to 5°C, keep it warm for 18 hours, slowly raise the temperature to 25°C, keep it warm for 3 hours, press the plug, and cover it.

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Abstract

The invention discloses a sodium rabeprazole preparation for injection and a preparing method thereof. The sodium rabeprazole preparation for the injection is prepared from the following components in parts by weight: 20 parts of sodium rabeprazole, 40-60 parts of mannitol, 1-10 parts of arginine and 0.5-4 parts of alkaline pH (potential of Hydrogen) regulators. The sodium rabeprazole preparation for the injection and the preparing method thereof adopt the arginine as a stabilizer, can improve the stability of a solution after the sodium rabeprazole and 0.9% sodium chloride injection liquid are composited; further, the clinical usage safety of the sodium rabeprazole preparation for the injection is improved. The sodium rabeprazole preparation for the injection and the preparing method thereof are beneficial to the clinical popularization and usage of sodium rabeprazole for the injection.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a preparation of rabeprazole sodium for injection and a preparation method thereof. Background technique [0002] Rabeprazole sodium is a new type of proton pump inhibitor, which can be used for diseases such as duodenal ulcer, gastric ulcer, gastroesophageal reflux disease and Zoller-Ellison syndrome, and has the ability to selectively and strongly inhibit Helicobacter pylori. effect. [0003] Rabeprazole sodium, developed by Eisai, is another proton pump inhibitor after omeprazole and lansoprazole. For the treatment of various digestive disorders related to acid secretion. [0004] The mother nucleus of rabeprazole sodium is sulfinylbenzimidazole, which is extremely hygroscopic, poor in stability, and sensitive to acid, light, heat, etc. Rabeprazole sodium is extremely unstable in aqueous solution and easily decomposes in acid . Under alkaline conditions...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04A61P31/04
CPCA61K9/19A61K31/4439A61K47/183
Inventor 邹玲玲徐旻明谢树伟陈蔚江
Owner WUHAN LEADPHARM TECH CO LTD
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