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Lansoprazole composition for injection

A technology for lansoprazole and a composition, applied in the field of pharmaceutical preparation, can solve problems such as unsolved technical defects, and achieve the effects of improving quality level, reducing production cost and preventing reaction

Active Publication Date: 2011-08-17
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 200710122134.0 discloses a pharmaceutical composition of lansoprazole, which contains not less than 10% by weight of an alkaline substance as a stabilizer, and is used to treat peptic ulcer, without solving the above-mentioned technical defects

Method used

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  • Lansoprazole composition for injection
  • Lansoprazole composition for injection
  • Lansoprazole composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Embodiment 1 prepares the lansoprazole composition for injection

[0071] prescription:

[0072] Lansoprazole 300g

[0073] EDTA 6g

[0074] Add water for injection to 20Kg

[0075] 1) Preparation of liquid medicine: Weigh lansoprazole and disodium edetate into a preparation tank, add water for injection, stir to mix evenly, add sodium hydroxide to dissolve and adjust the pH value of the solution to 11.5;

[0076] 2) Rubber stopper treatment:

[0077] 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;

[0078] 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;

[0079] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection filtered through a 0.22 μm filter for...

Embodiment 2

[0082] Embodiment 2 prepares the lansoprazole composition for injection

[0083] prescription:

[0084] Lansoprazole 300g

[0085] EDTA 9g

[0086] Add water for injection to 20Kg

[0087] 1) Preparation of liquid medicine: Weigh lansoprazole and disodium edetate into a preparation tank, add water for injection, stir to mix evenly, add sodium hydroxide to dissolve and adjust the pH value of the solution to 11.7;

[0088] 2) Rubber stopper treatment:

[0089] 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;

[0090] 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;

[0091] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection filtered through a 0.22 μm filte...

Embodiment 3

[0094] Embodiment 3 prepares the lansoprazole composition for injection

[0095] prescription:

[0096] Lansoprazole 300g

[0097] EDTA 12g

[0098] Add water for injection to 20Kg

[0099] 1) Preparation of liquid medicine: Weigh lansoprazole and disodium edetate into a preparation tank, add water for injection, stir to mix evenly, add sodium hydroxide to dissolve and adjust the pH value of the solution to 11.9;

[0100] 2) Rubber stopper treatment:

[0101] 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;

[0102] 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;

[0103] c. Take the rubber stopper that has been treated in the process of b, rinse it with water for injection filtered through a 0.22 μm filt...

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Abstract

The invention provides a lansoprazole composition for injection, containing lansoprazole and disodium ethylenediaminetetraacetate, wherein the weight ratio of the lansoprazole to the disodium ethylenediaminetetraacetate is 1:(0.02-0.1). The composition is prepared by the following steps: (1) medical liquid preparation: putting the lansoprazole and the disodium ethylenediaminetetraacetate into a preparation tank, adding water for injection, stirring to mix uniformly, adding sodium hydroxide to dissolve the lansoprazole and the disodium ethylenediaminetetraacetate, and adjusting the pH value to 11.5-12.0; (2) rubber plug processing; (3) aseptic filtration and subpackage; and (4) vacuum freezing and drying. For lansoprazole medicaments which are very easy to react with effusion from the rubber plug, the lansoprazole composition for injection, provided by the invention, can simultaneously and effectively ensure that visible foreign matters and insoluble particles of products conform to the requirement of an injection. The invention remarkably improves the quality of products, avoids hidden dangers brought to the clinical medication safety of patients due to the unqualified visible foreign matters and insoluble particles, and achieves a better curative effect and a lower clinical adverse reaction rate.

Description

technical field [0001] The invention relates to a lansoprazole composition for injection, which belongs to the technical field of medicine preparation. Background technique [0002] The chemical name of lansoprazole is 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl-1H- Benzimidazole], the structural formula is [0003] Lansoprazole is a proton pump inhibitor. After the drug is distributed in the acidic environment of the parietal cells of the gastric mucosa, it is converted into active metabolites. This metabolite interacts with the H present at the site of acid generation + , K + - Sulfhydryl binding of ATPase, through inhibition of H + , K + - ATPase activity inhibits acid secretion. [0004] Lansoprazole inhibits gastric acid secretion in a dose-dependent manner, and has inhibitory effects on both basal and stimulated gastric acid secretion within 24 hours after administration. For healthy adults, 30 mg once a day, administered intravenously t...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/18A61K9/19A61P1/04A61J1/14
Inventor 赵俊叶东蔡继兰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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