Mesalazine-containing drug composition

A composition and drug technology, applied in the field of pharmaceutical compositions containing mesalazine, can solve the problems of affecting the therapeutic effect, failure, and easy to be oxidized

Inactive Publication Date: 2015-06-17
四川健能制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Mesalazine is a commonly used drug for the treatment of inflammatory colitis. Due to its excellent therapeutic efficacy, it is widely used in the world. However, due to its structure with three active reactive groups, hydroxyl and carboxyl, it can A variety of reactions are easily oxidized and invalidated during the production process, thereby affecting the therapeutic effect. Therefore, it is necessary to control the temperature and humidity to reduce the occurrence of chemical reactions, protect the content of active ingredients, and reduce the production of related substances. The above chemical The occurrence of the reaction is mainly reflected in the change of the color of mesalazine. In the solution, if there is a chemical reaction, the color of the mesalazine solution gradually turns purple from the initial milky white to light brown solution, and finally turns black. Therefore, most of the existing preparations containing mesalamine are solid preparations, which is conducive to the stability of mesalamine and is not easy to change color and deteriorate. However, the main action site of mesalamine is in the colon, and the solid preparation must first pass through the gastrointestinal tract to reach the colon. , delaying the onset of action

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Prescription (specification: 60g:4g):

[0013]

[0014] Preparation Process:

[0015] Take prescription amount of calcium sodium edetate, sodium acetate, sodium benzoate, add appropriate amount of purified water and stir to dissolve, under stirring, add prescription amount of xanthan gum and carbomer, stir to swell, add prescription amount of bisulfite Sodium and mesalazine, stir and mix well, homogenize, add water to the full amount, stir evenly, and fill it. The measured PH value is 3.5, and the measured particle size is 90%. The particle size ranges from 8 microns to 15 microns.

Embodiment 2

[0017] Prescription (specification: 60g:4g):

[0018]

[0019] Preparation Process:

[0020] Take prescription amount of disodium edetate, sodium acetate, sodium benzoate, add appropriate amount of purified water and stir to dissolve, under stirring, add prescription amount of xanthan gum and carbomer, stir to swell, add prescription amount of vitamin C, Mesalazine, stir and mix well, homogenize, add water to the full amount, stir evenly, and fill it. The measured PH value is 5.5, and the measured particle size is 90%. The particle size ranges from 8 microns to 15 microns.

Embodiment 3

[0022] Prescription (specification: 60g:4g):

[0023]

[0024] Preparation Process:

[0025] Take prescription amount of disodium edetate, sodium acetate, sodium benzoate, add appropriate amount of purified water and stir to dissolve, under stirring, add prescription amount of xanthan gum and carbomer, stir and swell, add prescription amount of sodium metabisulfite, Mesalazine, stir and mix well, homogenize, add water to the full amount, stir evenly, and fill it. The measured PH value is 4.8, and the measured particle size is 90%. The particle size ranges from 8 microns to 15 microns.

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Abstract

The present invention provides a mesalazine-containing drug composition, wherein per 60 g of the composition comprises 4 g of mesalazine, 0.04-0.1 g of a metal chelating agent, 0.1-0.5 g of an antioxidant, 0.01-0.2 g of a preservative, 0.1-0.4 g of an auxiliary suspending agent, 0.1-0.4 g of a pH value adjusting agent, and the balance of water. The enema liquid has good stability.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a composition containing mesalazine as an active ingredient, in particular to a pharmaceutical composition containing mesalazine. Background technique [0002] Mesalazine is a commonly used medicine for the treatment of inflammatory colitis. Because of its excellent therapeutic effects, it is widely used worldwide. However, because of its structure has three active reactive groups, hydroxyl and carboxyl, it can be used for A variety of reactions are easily oxidized during the production process and become invalid, thereby affecting the therapeutic effect. Therefore, the temperature and humidity must be controlled to reduce the occurrence of chemical reactions, protect the content of active ingredients, and reduce the production of related substances. The occurrence of the reaction is mainly reflected in the color change of mesalazine. In the solution, if there is a chemical re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/36A61K47/32A61K31/606A61P1/00
Inventor 王国华胡延贵王进涛刘萍熊尉莛杨帆帆
Owner 四川健能制药有限公司
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