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Pantoprazole sodium composition for injection

A technology of pantoprazole sodium and its composition, which is applied in the field of pharmaceutical preparation, can solve problems such as unresolved technical defects, and achieve the effects of improving the quality level, avoiding scrapping, and good curative effect

Active Publication Date: 2011-10-26
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN200810001189.0 discloses a pantoprazole sodium freeze-dried powder injection, including pantoprazole sodium and mannitol, adopts advanced freeze-drying process, does not solve the above-mentioned technical defects

Method used

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  • Pantoprazole sodium composition for injection
  • Pantoprazole sodium composition for injection
  • Pantoprazole sodium composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Embodiment 1 prepares the pantoprazole sodium composition for injection

[0088] prescription:

[0089] Pantoprazole Sodium 423g

[0090] EDTA 8.46g

[0091] Add water for injection to 20Kg

[0092] 1) Preparation of liquid medicine: Weigh pantoprazole 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 12.5 with sodium hydroxide;

[0093] 2) Rubber stopper treatment:

[0094] 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;

[0095] b. Take the rubber stopper, add solution a according to the weight ratio of the stopper and solution a of 1:10, heat to 47°C and keep it warm for 30 minutes;

[0096] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection filtered t...

Embodiment 2

[0099] Embodiment 2 prepares the pantoprazole sodium composition for injection

[0100] prescription:

[0101] Pantoprazole Sodium 423g

[0102] EDTA 21.15g

[0103] Add water for injection to 20Kg

[0104] 1) Preparation of liquid medicine: Weigh pantoprazole sodium and disodium edetate into a preparation tank, add water for injection, stir to dissolve and mix evenly, and adjust the pH value of the solution to 11.8 with sodium hydroxide;

[0105] 2) Rubber stopper treatment:

[0106] 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;

[0107] b. Take the rubber stopper, add solution a according to the weight ratio of the stopper and solution a of 1:10, heat to 47°C and keep it warm for 30 minutes;

[0108] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection filte...

Embodiment 3

[0111] Embodiment 3 prepares the pantoprazole sodium composition for injection

[0112] prescription:

[0113] Pantoprazole Sodium 423g

[0114] EDTA 42.3g

[0115] Add water for injection to 20Kg

[0116] 1) Preparation of liquid medicine: Weigh pantoprazole sodium and disodium edetate into a preparation tank, add water for injection, stir to dissolve and mix evenly, and adjust the pH value of the solution to 10.9 with sodium hydroxide;

[0117] 2) Rubber stopper treatment:

[0118] 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;

[0119] 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;

[0120] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection filte...

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Abstract

The invention provides a pantoprazole sodium composition for injection. The composition contains pantoprazole sodium and disodium ethylene diamine tetraacetate that are in a proportion of 1:0.02-0.1 by weight. And the composition is prepared by the steps of: 1) liquid medicine preparation: placing pantoprazole sodium and disodium ethylene diamine tetraacetate in a preparation pot, adding water for injection and stirring to make the above agents dissolved and mixed well with the water, adjusting the pH value of the mixture to 10.5-12.5; 2) rubber stopper treatment; 3) aseptic filtration and separate packing; 4) vacuum freeze drying, thus obtaining the composition. For pantoprazole sodium medicaments extremely easy to react with exudates from a rubber stopper, the pantoprazole sodium composition for injection in the invention can simultaneously guarantee the visible foreign matters and insoluble particles in products meeting the requirement of an injection. According to the invention, quality level of the composition product is improved, and the hidden trouble that unqualified visible foreign matters and insoluble particles threat patient clinical medication safety can be avoided. Additionally, the composition of the invention has better curative effects and less clinical side effects.

Description

technical field [0001] The invention relates to a pantoprazole sodium composition for injection, which belongs to the technical field of medicine preparation. Background technique [0002] The chemical name of pantoprazole sodium is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzoimidazole Sodium, the structural formula is [0003] [0004] Pantoprazole sodium is a new generation of proton pump inhibitor (PPI) after omeprazole and lansoprazole, and it is the first-line treatment drug for peptic ulcer disease. After being marketed globally, it immediately became a specific drug for the treatment of acid-related digestive system dysfunction diseases due to its strong and long-lasting acid suppression effect, high ulcer healing rate, few adverse reactions and few drug interactions. [0005] Pantoprazole sodium is unstable in an acidic environment, and in the preparation process, a higher pH value (usually above 9.5) has been adopted to improve the phy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/19A61P1/04
Inventor 张建义叶东王孝雯
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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