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Mesalazine enteric sustained-release tablet preparation method

A technology of mesalamine and sustained-release tablets, applied in the field of medicine

Inactive Publication Date: 2018-06-15
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a method for preparing mesalazine enteric-coated sustained-release tablets, which mainly solves the problem of the preparation process of large-scale mesalazine enteric-coated sustained-release tablets

Method used

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  • Mesalazine enteric sustained-release tablet preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The prescription for mesalamine enteric-coated sustained-release tablets (1000 tablets) is as follows:

[0022] Chip part

[0023]

[0024] Coating part

[0025]

[0026] The preparation method of mesalamine enteric-coated sustained-release tablet is as follows:

[0027] (1) Povidone K30 is dissolved in water to make 35% binder solution, for subsequent use;

[0028] (2) Put mesalamine, stearic acid, and carnauba wax in the fast wet mixing granulator according to the prescription amount, mix evenly, and slowly add the binder solution into the fast wet mixing under stirring and shearing In the granulator, keep stirring and shearing until a suitable soft material is formed;

[0029] (3) After the soft material is fed into the extruder and extruded into thin strips through a sieve plate with an aperture of 1.0mm, it is properly spheronized by a spheronizer, and after boiling and drying at 40±5°C, dry granules are obtained;

[0030] (4) After the dry granules and t...

Embodiment 2

[0034] The prescription for mesalamine enteric-coated sustained-release tablets (1000 tablets) is as follows:

[0035] Chip part

[0036]

[0037] Coating part

[0038]

[0039] The preparation method of mesalamine enteric-coated sustained-release tablet is as follows:

[0040] (1) Povidone K90 is dissolved in water to make 12% binder solution, for subsequent use;

[0041] (2) Put mesalamine, stearic acid, and carnauba wax in the fast wet mixing granulator according to the prescription amount, mix evenly, and slowly add the binder solution into the fast wet mixing under stirring and shearing In the granulator, keep stirring and shearing until a suitable soft material is formed;

[0042] (3) After the soft material is fed into the extruder and extruded into thin strips through a sieve plate with an aperture of 1.0mm, it is properly spheronized by a spheronizer, and after boiling and drying at 40±5°C, dry granules are obtained;

[0043] (4) After the dry granules and t...

Embodiment 3

[0047] The prescription for mesalamine enteric-coated sustained-release tablets (1000 tablets) is as follows:

[0048] Chip part

[0049]

[0050]

[0051] Coating part

[0052]

[0053] The preparation method of mesalamine enteric-coated sustained-release tablet is as follows:

[0054] (1) Povidone K90 is dissolved in water to make 10% adhesive solution, for subsequent use;

[0055] (2) Put mesalamine, stearic acid, and carnauba wax in the fast wet mixing granulator according to the prescription amount, mix evenly, and slowly add the binder solution into the fast wet mixing under stirring and shearing In the granulator, keep stirring and shearing until a suitable soft material is formed;

[0056] (3) After the soft material is fed into the extruder and extruded into thin strips through a sieve plate with an aperture of 1.0mm, it is properly spheronized by a spheronizer, and after boiling and drying at 40±5°C, dry granules are obtained;

[0057] (4) After the dry gr...

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Abstract

The invention relates to a mesalazine enteric sustained-release tablet preparation method, and belongs to the technical field of medicine. According to the present invention, a mesalazine enteric sustained-release tablet core is prepared by using wet granulation and tableting, and the mesalazine enteric sustained-release tablet is prepared through enteric coating, wherein each tablet contains 1.2g of mesalazine.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of mesalamine enteric-coated sustained-release tablets each containing 1.2 g of mesalamine. Background technique [0002] Ulcerative colitis (ulcerative colitis, UC) is a chronic, inflammatory and ulcerative disease that occurs in the colonic mucosa. Due to the wide range of lesions, recurrent attacks, and high possibility of cancer, UC is currently recognized as one of the most difficult diseases to cure. Ulcerative colitis is very common in western countries, and the number of cases reported in my country has increased significantly in recent years with the improvement of living standards. According to the statistics of cases in many hospitals, the incidence of UC in China is about 30 cases per 100,000 people. Of course, the actual cases may be more. Ulcerative colitis is a common disease of the digestive system and an important cause of chronic diarrhea in China,...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K31/606A61K47/32A61K47/44A61P1/00A61P1/04
CPCA61K9/2846A61K9/0002A61K9/2013A61K9/2027A61K9/2086A61K9/2095A61K9/2813A61K31/606
Inventor 尹东东王杏林朱雪瑜
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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