Method for preparing mesalazine enteric-coated sustained-release capsule

A technology of mesalamine and sustained-release capsules, which is applied in the field of preparation of mesalamine enteric-coated sustained-release capsules, can solve the problems of long residence time, weak digestion ability, coating failure, etc., and achieve the goal of improving the probability of cure and good drug efficacy Effect

Inactive Publication Date: 2021-04-02
南京森博医药研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some patients have weak digestion ability, and the drug stays in the stomach for too long after taking it. Even with the protection of enteric coating, the coating will often fail due to long-term immersion in gastric juice, causing the drug to disintegrate early

Method used

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  • Method for preparing mesalazine enteric-coated sustained-release capsule
  • Method for preparing mesalazine enteric-coated sustained-release capsule

Examples

Experimental program
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Effect test

Embodiment 1

[0046] like figure 1 and 2 Shown, a kind of method for preparing mesalamine enteric-coated sustained-release capsule, mesalamine enteric-coated sustained-release capsule comprises capsule body 1 and the mesalamine enteric-coated sustained-release tablet 3 that is sealed and accommodated in capsule body 1 and The number of pH buffer granules 2 and mesalamine enteric-coated sustained-release tablets 3 in mesalamine enteric-coated sustained-release capsules is more than two. The method includes the following steps:

[0047] S1. Preparation of mesalamine enteric-coated sustained-release tablets 3. This step includes the following sub-steps:

[0048] S11, the mesalazine of 110 mass parts, the dextrin of 5 mass parts, the starch of 12 mass parts, the mannitol of 22 mass parts, the microcrystalline cellulose of 14 mass parts, the magnesium stearate of 1.8 mass parts and 100 mass parts Parts of pure water are fully mixed and stirred to obtain a soft billet.

[0049] S12, extrudin...

Embodiment 2

[0064] A method for preparing mesalamine enteric-coated sustained-release capsules, comprising the steps of:

[0065] S1. Preparation of mesalamine enteric-coated sustained-release tablets 3. This step includes the following sub-steps:

[0066] S11, the mesalazine of 120 mass parts, the dextrin of 7 mass parts, the starch of 16 mass parts, the mannitol of 26 mass parts, the microcrystalline cellulose of 16 mass parts, the magnesium stearate of 2.2 mass parts and 140 Parts by mass of pure water are fully mixed and stirred to obtain a soft billet.

[0067] S12, extruding the soft billet to obtain a billet, the diameter of the billet is 5 mm.

[0068] S13, cutting the billet into slices, the thickness of which is 3 mm.

[0069] S14, pressing the blank into a tablet, the diameter of the tablet is 6mm, and the thickness is 2mm.

[0070]S15, drying and coating the tablet to obtain the mesalazine enteric-coated sustained-release tablet 3.

[0071] S2. Prepare the capsule body 1....

Embodiment 3

[0082] A method for preparing mesalamine enteric-coated sustained-release capsules, the method comprising the steps of:

[0083] S1. Preparation of mesalamine enteric-coated sustained-release tablets 3. This step includes the following sub-steps:

[0084] S11, the mesalazine of 115 mass parts, the dextrin of 6 mass parts, the starch of 14 mass parts, the mannitol of 24 mass parts, the microcrystalline cellulose of 15 mass parts, the magnesium stearate of 2 mass parts and 120 Parts by mass of pure water are fully mixed and stirred to obtain a soft billet.

[0085] S12, extruding the soft billet to obtain a billet, the diameter of the billet is 5mm.

[0086] S13, cutting the billet into slices, the thickness of which is 3mm.

[0087] S14, pressing the blank into a tablet, the diameter of the tablet is 6mm, and the thickness is 2mm.

[0088] S15, drying and coating the tablet to obtain the mesalazine enteric-coated sustained-release tablet 3.

[0089] S2. Prepare the capsule...

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Abstract

The invention provides a method for preparing a mesalazine enteric-coated sustained-release capsule. The mesalazine enteric-coated sustained-release capsule comprises a capsule body, and mesalazine enteric-coated sustained-release tablets and pH buffer particles which are hermetically accommodated in the capsule body, wherein the number of the mesalazine enteric-coated sustained-release tablets inthe mesalazine enteric-coated sustained-release capsule is more than two; the method comprises the following steps of preparing the mesalazine enteric-coated sustained release tablets; preparing thecapsule body; preparing the PH buffer particles; and filling the capsule body with the pH buffer particles and the mesalazine enteric-coated sustained-release tablet. The sustained-release capsule disclosed by the invention comprises the sustained-release tablets playing a main pharmacodynamic role and the buffer agent for changing the pH value of the gastric environment, the sustained-release tablets and the buffer agent are taken by a patient in a capsule manner, and the pH buffer agent improves the pH value of gastric juice after the capsule is disintegrated in the stomach, so that the disintegration probability of the sustained-release tablets staying in the gastric juice for a long time is reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparation production, and in particular relates to a method for preparing mesalamine enteric-coated sustained-release capsules. Background technique [0002] Mesalamine is the active ingredient of SASP for the treatment of ulcerative colitis, and it has a significant inhibitory effect on the inflammation of the intestinal wall; Mucosa inflammation plays a significant inhibitory role, mesalamine can inhibit the synthesis of prostaglandins in a dose-dependent manner, and reduce the release of PGE2 in human colonic mucosa. [0003] At present, the common mesalamine tablets are all coated tablets, and a layer of enteric coating is added to the outermost layer, so that the drug will not disintegrate in the gastric juice in advance after passing through the patient's stomach, so that the active ingredients are more stable. Acts well on the intestinal mucosa. However, some patients have weak d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/36A61K47/38A61K47/26A61K31/606A61P1/00A61P1/04
CPCA61K9/4808A61K9/4858A61K9/4866A61K31/606A61P1/00A61P1/04
Inventor 赵冰清骆晓群徐晶欧明月
Owner 南京森博医药研发有限公司
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