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Granulating and coating process of esomeprazole magnesium contained in esomeprazole magnesium enteric-coated tablet

A technology of esomeprazole magnesium and enteric-coated tablets, which is applied to medical preparations containing active ingredients, pill delivery, organic active ingredients, etc. It can solve the problems of unqualified product content uniformity and achieve good drug release characteristics Effect

Active Publication Date: 2013-04-17
SHANGHAI SINE WANXIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The object of the present invention is to: provide a kind of granulation coating technology of esomeprazole magnesium in the esomeprazole magnesium enteric-coated tablet, to solve the problem of material in the existing esomeprazole magnesium enteric-coated tablet tableting process. Delamination caused the problem of unqualified product content uniformity

Method used

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  • Granulating and coating process of esomeprazole magnesium contained in esomeprazole magnesium enteric-coated tablet
  • Granulating and coating process of esomeprazole magnesium contained in esomeprazole magnesium enteric-coated tablet
  • Granulating and coating process of esomeprazole magnesium contained in esomeprazole magnesium enteric-coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] A kind of preparation method of esomeprazole magnesium enteric-coated tablet is as follows: first make esomeprazole magnesium granule, pass through isolation layer coating, enteric layer coating successively again, make esomeprazole magnesium enteric coating Dissolve the granules, and finally mix the esomeprazole magnesium enteric-coated granules with auxiliary materials for tableting to obtain esomeprazole magnesium enteric-coated tablets;

[0059] The enteric-coated tablets are prescribed as follows:

[0060] 1. Prescription of Esomeprazole Magnesium Granules:

[0061]

[0062] 2. Prescription of Esomeprazole Magnesium Isolation Layer Coating Solution:

[0063]

[0064] 3. Prescription of Esomeprazole Magnesium Enteric Layer Coating Solution

[0065]

[0066]

[0067] The granulation and coating process steps of esomeprazole magnesium in the above-mentioned esomeprazole magnesium enteric-coated tablets are as follows:

[0068] 1. Granulation:

[0069] ...

Embodiment 2

[0090] The preparation method is basically the same as in Example 1, except that:

[0091] 1. Prescription of Esomeprazole Magnesium Granules (the dosage unit of each material is kg):

[0092]

[0093] 2. Prescription of Esomeprazole Magnesium Isolation Layer Coating Solution (the dosage unit of each material is kg):

[0094]

[0095]

[0096] 3. Prescription of Esomeprazole Magnesium Enteric-coated Layer Coating Solution (the dosage unit of each material is kg)

[0097]

[0098] Granulation step (3), put the mixed powder (1) and the prescribed amount of microcrystalline cellulose in a three-phase wet granulator and mix for 4 minutes, add povidone aqueous solution (2), and stir for 10 minutes to make suitable granules ; Granulation step (4), the wet granules are dried in a boiling dryer, and the temperature of the material reaches 40°C, and the drying is completed.

[0099] Isolation layer coating step (3), when the particle temperature in the boiling coating mac...

Embodiment 3

[0101] The preparation method is basically the same as in Example 1, except that:

[0102] Prescription of Esomeprazole Magnesium Granules (the dosage unit of each material is kg):

[0103]

[0104]

[0105] 2. Prescription of Esomeprazole Magnesium Isolation Layer Coating Solution (the dosage unit of each material is kg):

[0106]

[0107] 3. Prescription of Esomeprazole Magnesium Enteric-coated Layer Coating Solution (the dosage unit of each material is kg)

[0108]

[0109] Granulation step (3), put the mixed powder (1) and the prescribed amount of microcrystalline cellulose in a three-phase wet granulator and mix for 3 minutes, add povidone aqueous solution (2), and stir for 9 minutes to make suitable granules ; Granulation step (4), the wet granules are dried in a boiling dryer, and the material temperature reaches 38°C, and the drying is completed.

[0110] Isolation layer coating step (3), when the particle temperature in the boiling coating machine reache...

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Abstract

The invention provides a granulating and coating process of esomeprazole magnesium contained in esomeprazole magnesium enteric-coated tablets. The granulating and coating process comprises the following steps of: firstly preparing esomeprazole magnesium granules; then preparing esomeprazole magnesium enteric-coated granules sequentially through isolating layer coating and enteric-coated layer coating; and finally blending adjuvants with the esomeprazole magnesium enteric-coated granules and tabletting to prepare the esomeprazole magnesium enteric-coated tablets. An appropriate granulating method comprises the following steps of: crushing and grinding the esomeprazole magnesium and the adjuvants into powder, and then uniformly mixing; mixing with an adhesive to obtain a water solution, stirring for 8-10 minutes in a wet type granulator to prepare appropriate granules; drying at 40-45 DEG C, and screening to obtain the granules with grain size being between 40 meshes and 80 meshes. According to the process including granulating and coating of raw materials, the enteric-coated granules are prepared firstly and then blended with the adjuvants and finally tabletting is carried out, pellets are not used, the content uniformity of the prepared esomeprazole magnesium enteric-coated tablet product is greatly enhanced, and the problem of unqualified uniformity of the product content caused by excessive material flowability in an original process is solved.

Description

technical field [0001] The invention belongs to the technical field of granulation and coating technology of medicines, and in particular relates to a granulation and coating process of esomeprazole magnesium in enteric-coated tablets of esomeprazole magnesium. Background technique [0002] The existing preparation process of Esomeprazole Magnesium Enteric-coated Tablets adopts pellet compression technology, that is, enteric-coated pellets are first made into enteric-coated pellets through three coating processes (drug layer, isolation layer, enteric layer), and then mixed Tablet compression with excipients, because the pellets are very round and have excess fluidity, it is easy to delaminate with excipients in the process of tablet compression, resulting in unqualified product content uniformity. Contents of the invention [0003] The object of the present invention is to: provide a kind of granulation coating technology of esomeprazole magnesium in the esomeprazole magne...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4439
Inventor 顾煜史红顾振洪卢晓玲
Owner SHANGHAI SINE WANXIANG PHARMA
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