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Sodium rabeprazole composition used for injection

A technology of rabeprazole sodium and a composition, which is applied in the field of pharmaceutical preparation, can solve the problems of unsatisfactory barrier effect of inert membrane, unqualified insoluble particles of preparations, and no solution to technical defects, achieves good economic significance, avoids scrap, improves Effect of quality level

Active Publication Date: 2012-09-19
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN 200810055810.1 discloses a freeze-dried powder preparation containing dex-rabeprazole and its salt and its preparation process, which does not solve the above-mentioned technical defects

Method used

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  • Sodium rabeprazole composition used for injection
  • Sodium rabeprazole composition used for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Example 1 Preparation of Rabeprazole Sodium Compositions for Injection

[0087] prescription:

[0088] Rabeprazole Sodium 213g

[0089] EDTA 4.26g

[0090] Add water for injection to 20Kg

[0091] 1) Preparation of liquid medicine: Weigh rabeprazole sodium and disodium edetate into a preparation tank, add water for injection, stir to dissolve and mix evenly, adjust the pH value of the solution to 10.5 with sodium hydroxide;

[0092] 2) Rubber stopper treatment:

[0093] a. Take disodium edetate, add water for injection according to the weight ratio of disodium edetate and water for injection 1:1000, adjust the pH value to 7.0 with sodium hydroxide after stirring and dissolving;

[0094] b. Take the rubber stopper, add solution a according to the weight ratio of the stopper and solution a of 1:10, heat to 41°C and keep it warm for 30 minutes;

[0095] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injectio...

Embodiment 2

[0098] Example 2 Preparation of Rabeprazole Sodium Compositions for Injection

[0099] prescription:

[0100] Rabeprazole Sodium 213g

[0101] EDTA 6.39g

[0102] Add water for injection to 20Kg

[0103] 1) Preparation of medicinal solution: Weigh rabeprazole sodium and disodium edetate into a preparation tank, add water for injection, stir to dissolve and mix evenly, adjust the pH value of the solution to 11.5 with sodium hydroxide;

[0104] 2) Rubber stopper treatment:

[0105] a. Get disodium edetate, add water for injection according to the weight ratio of disodium edetate and water for injection 1:1000, adjust the pH value to 6.0 with sodium hydroxide after stirring and dissolving;

[0106] b. Take the rubber stopper, add solution a according to the weight ratio of the stopper and solution a of 1:10, heat to 41°C and keep it warm for 30 minutes;

[0107] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for inject...

Embodiment 3

[0110] Example 3 Preparation of Rabeprazole Sodium Compositions for Injection

[0111] prescription:

[0112] Rabeprazole Sodium 213g

[0113] EDTA 8.52g

[0114] Add water for injection to 20Kg

[0115] 1) Preparation of medicinal solution: Weigh rabeprazole sodium and disodium edetate into a preparation tank, add water for injection, stir to dissolve and mix evenly, adjust the pH value of the solution to 11.0 with sodium hydroxide;

[0116] 2) Rubber stopper treatment:

[0117] a. Get disodium edetate, add water for injection according to the weight ratio of disodium edetate and water for injection 1:1000, adjust the pH value to 6.5 with sodium hydroxide after stirring and dissolving;

[0118] b. Take the rubber plug, add solution a according to the weight ratio of rubber plug and solution a 1:10, heat to 45°C and keep it warm for 30 minutes;

[0119]c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection fil...

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Abstract

The invention provides a sodium rabeprazole composition used for injection, which comprises sodium rabeprazole and disodium ethylene diamine tetraacetate, wherein, the weight ratio of sodium rabeprazole and disodium ethylene diamine tetraacetate is 1:0.02-0.1, the composition is prepared by the following steps: 1) liquid preparing: weighting sodium rabeprazole and disodium ethylene diamine tetraacetate to place into a preparation vessel, adding water for injection, stirring for dissolving and then well mixing and regulating the pH value to 10.5-11.5; 2) robber plug treating; 3) aseptic filtering and packaging; 4) vacuum freeze-drying. According to the invention, medicines such as sodium rabeprazole are easy to react with an exudate in a robber plug, so that the sodium rabeprazole composition used for injection is capable of ensuring the product visible foreign matter and insolubility particle accord with the injection requirement. The present invention can obviously improve the quality of the product, and avoids the hidden troubles brought by defective visible foreign matter and insolubility particle to clinic safe medication of patients, the composition provided in the invention has better curative effect and lower clinic side effect.

Description

technical field [0001] The invention relates to a rabeprazole sodium composition for injection, which belongs to the technical field of medicine preparation. Background technique [0002] The chemical name of Rabeprazole sodium is 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-1H- Benzimidazole sodium salt, the structural formula is [0003] [0004] Rabeprazole sodium is a new product developed by Japan's Eisai Company, code-named E-3810. It was first launched in Japan in 1997. In 1999, this product was launched in the United States and Sweden. The dosage form is enteric-coated tablets. For the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux, esophagitis, Zoller-Ellison syndrome and other indications. As a new generation of proton pump inhibitors, rabeprazole sodium has a high pKa value, is rapidly activated in the body, and combines with proton pumps to exert an acid-suppressing effect. Compared with the first-generation proton pu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439A61K47/18A61K47/10A61K9/19
Inventor 戴建国叶东陈继龙
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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