Mesalazine oral sustained-release preparation

A technology of mesalazine and controlled-release preparations, which is applied in the direction of pill delivery, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. It can solve the problems of poor slow-release effect and achieve slow release speed, release even effect

Inactive Publication Date: 2019-03-15
重庆健能医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent CN 101721385 discloses a mesalazine oral controlled-release pharmaceutical composition, which contains a sustained-release tablet core of mesalazine or its pharmaceutically acceptable salt or its solvate and a hydrophilic matrix, wherein mesalazine or its pharmaceutically acceptable The salt is dispersed in the hydrophilic matrix, and the tablet is

Method used

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  • Mesalazine oral sustained-release preparation
  • Mesalazine oral sustained-release preparation
  • Mesalazine oral sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1. Prescription:

[0023]

[0024] 2. Process steps:

[0025] (1) Mesalazine, stearic acid and carnauba wax are heated, mixed, stirred and granulated in a hot melt machine, and the obtained granules are cooled to room temperature;

[0026] (2) adding the treated mesalazine in the mixer, adding the sodium carboxymethyl cellulose, hydrogenated castor oil, sodium carboxymethyl starch of recipe quantity therein, and making it mix homogeneously;

[0027] (3) talcum powder, silicon dioxide and magnesium stearate of recipe quantity are added in above-mentioned mixer, carry out mixing process again, make it mix homogeneously;

[0028] (4) the above-mentioned mixture is subjected to tableting treatment;

[0029] (5) The tablet is film-coated with enteric-coated premixed powder to provide gastric acid resistance and prevent premature release of the product in the stomach.

Embodiment 2

[0031] 1. Prescription:

[0032]

[0033]

[0034] 2. Process steps:

[0035] (1) Mesalazine, stearic acid and carnauba wax are heated, mixed, stirred and granulated in a hot melt machine, and the obtained granules are cooled to room temperature;

[0036] (2) adding the treated mesalazine in the mixer, adding the sodium carboxymethyl cellulose, hydrogenated castor oil, sodium carboxymethyl starch of the recipe quantity therein, and making it evenly mixed;

[0037] (3) talcum powder, silicon dioxide and magnesium stearate of recipe quantity are added in above-mentioned mixer, carry out mixing process again, make it mix homogeneously;

[0038] (4) the above-mentioned mixture is subjected to tableting treatment;

[0039] (5) The tablet is film-coated with enteric-coated premixed powder to provide gastric acid resistance and prevent premature release of the product in the stomach.

Embodiment 3

[0041] 1. Prescription:

[0042]

[0043] 2. Process steps:

[0044] (1) Mesalazine and carnauba wax are heated, mixed, stirred and granulated in a hot melt machine, and the obtained granules are cooled to room temperature;

[0045] (2) adding the treated mesalazine in the mixer, adding the sodium carboxymethyl cellulose, hydrogenated castor oil, sodium carboxymethyl starch of the recipe quantity therein, and making it evenly mixed;

[0046] (3) talcum powder, silicon dioxide and magnesium stearate of recipe quantity are added in above-mentioned mixer, carry out mixing process again, make it mix homogeneously;

[0047] (4) the above-mentioned mixture is subjected to tableting treatment;

[0048] (5) The tablet is film-coated with enteric-coated premixed powder to provide gastric acid resistance and prevent premature release of the product in the stomach.

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Abstract

The invention relates to a Mesalazine oral sustained-release pharmaceutical composition which is characterized by comprising the following ingredients by weight per one unit of preparation: 0.9g-1.3gof Mesalazine, 0.01g-0.05g of carnauba wax, 0.01g-0.05g of stearic acid, 0.05g-0.2g of hydrogenated castor oil, 0.05g-0.2g of sodium carboxymethylcellulose, 0.05g-0.2g of sodium carboxymethyl starch,0.005g-0.02g of silicon dioxide, 0.005g-0.02g of magnesium stearate, 0.005g-0.02g of talcum powder and 0.02g-0.1g of enteric coating powder. The invention also provides a preparation method of the Mesalazine oral sustained-release pharmaceutical composition. All the ingredients have a synergistic effect, so that the finally prepared composition is good in sustained-release effect and stable in property.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a mesalazine oral colon-targeted release pharmaceutical composition-a mesalazine oral sustained and controlled release preparation. Background technique [0002] Mesalazine (5-aminosalicylic acid) is a classic drug for the treatment of inflammatory colitis. The products currently on the market include mesalazine delayed-release tablets Asacol, mesalazine delayed-release tablets Pentasa and mesalazine enteric-coated sustained-release tablets Lialda. Asacol is coated with Eudragit S100 and is taken orally 3-4 times a day without sustained release effect; Pentasa is coated with ethyl cellulose and is taken orally 3-4 times a day with no sustained release effect; Lialda is a Mesala with MMX technology Qin sustained-release preparations only need to be taken orally once or twice a day. [0003] Chinese patent CN 100448448 discloses a controlled-release oral phar...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K47/44A61K47/38A61K47/36A61K31/606A61P1/00
CPCA61K9/28A61K9/2013A61K9/2054A61K9/2059A61K31/606A61P1/00
Inventor 王国华李于林王祖焕刘萍
Owner 重庆健能医药开发有限公司
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