Mesalazine enteric-coated sustained release tablet

A technology of mesalazine and sustained-release tablets, which is applied in the direction of pill delivery, digestive system, organic active ingredients, etc., and can solve problems such as changes in related substances

Inactive Publication Date: 2014-02-12
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

Although the patent improves the stability of the drug, i

Method used

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  • Mesalazine enteric-coated sustained release tablet
  • Mesalazine enteric-coated sustained release tablet
  • Mesalazine enteric-coated sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1. Prescription:

[0020]

[0021] 2. Process steps:

[0022] (1) Hypromellose (K15M) and mesalazine are mixed evenly, then part of the lubricant is added and mixed to obtain a mixed powder;

[0023] (2) The compressed tablet of mixed powder has a diameter of 7mm and a hardness of 4KG. Then the tablets are crushed through an 18-mesh sieve to obtain granules;

[0024] (3) The obtained granules are mixed with the remaining lubricant, and the tablets are compressed. The tablets are elliptical in shape and the long-side hardness is 14-17KG;

[0025] (4) The obtained tablets are coated with enteric coating powder.

Embodiment 2

[0027] 1. Prescription:

[0028]

[0029] 2. Process steps:

[0030] (1) Hypromellose (K4M) and mesalazine are mixed evenly, and then part of the lubricant is added and mixed to obtain a mixed powder;

[0031] (2) The compressed tablet of mixed powder has a diameter of 10mm and a hardness of 8KG. Then the tablets are crushed through a 14-mesh sieve to obtain granules;

[0032] (3) The obtained granules are mixed with the remaining lubricant, and the tablets are compressed. The tablets are elliptical in shape and the long-side hardness is 14-17KG;

[0033] (4) The obtained tablets are coated with enteric coating powder.

Embodiment 3

[0035] 1. Prescription:

[0036]

[0037] 2. Process steps:

[0038] (1) Hypromellose (K4M), hypromellose (K15M) and mesalazine are mixed uniformly, and then part of the lubricant is mixed to obtain a mixed powder;

[0039] (2) The compressed tablet of mixed powder has a diameter of 8mm and a hardness of 6KG. Then the tablets are crushed through an 18-mesh sieve to obtain granules;

[0040] (3) The obtained granules are mixed with the remaining lubricant, and the tablets are compressed. The tablets are elliptical in shape and the long-side hardness is 14-17KG;

[0041] (4) The obtained tablets are coated with enteric coating powder.

[0042] Release test

[0043] Release conditions: simulated release in pH7.2 intestinal juice, using 900ml of pH7.2 sodium phosphate buffer, paddle method, rotation speed, 50r / min, temperature: 36.5-37.5℃.

[0044] Samples were taken at 1 hour, 4 hours, and 8 hours to determine the release degree. The results are as follows:

[0045]

[0046] Stability test

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Abstract

The invention discloses a mesalazine enteric-coated sustained release tablet. The mesalazine enteric-coated sustained release tablet is characterized by consisting of the following components in a unit dose: 1.2g of mesalazine, 0.1-0.3g of a sustained release material, 0.004.0.03g of a lubricant and 0.02-0.1g of enteric-coated powder. The release of the mesalazine enteric-coated sustained release tablet in one hour in simulated intestinal fluid of which the pH value is 7.2 is less than 30%, the release in four hours is not more than 70%, and the release in eight hours exceeds 80%.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a sustained-release preparation containing mesalazine as an active ingredient, in particular to a mesalazine enteric-coated sustained-release tablet. Background technique [0002] Mesalazine is a commonly used medicine for the treatment of inflammatory colitis. Because of its excellent therapeutic effect, it is widely used worldwide. However, because of its structure has three active reactive groups of 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. [0003] The currently marketed mesalazine formulations are mainly ordinary enteric-coated preparations, and ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K31/606A61K47/38A61P1/00
Inventor 王国华胡延贵王进涛
Owner 四川健能制药有限公司
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