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Isosorbide mononitrate sustained release tablets and preparation process thereof

A technology of isosorbide dinitrate and sustained-release tablets, which is applied in the directions of non-active ingredients medical preparations, cardiovascular system diseases, pharmaceutical formulations, etc. Inhomogeneous and other problems, to achieve the effect of good drug release stability, no membrane aging, and high bioavailability

Inactive Publication Date: 2015-05-27
王加峰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The matrix-type sustained-release tablets have the problems of uneven drug release, sudden release or incomplete drug release; while the film-controlled sustained-release preparations have problems such as aging of the coating film and slow drug release after long-term storage

Method used

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  • Isosorbide mononitrate sustained release tablets and preparation process thereof
  • Isosorbide mononitrate sustained release tablets and preparation process thereof
  • Isosorbide mononitrate sustained release tablets and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0031]

[0032] Preparation Process:

[0033] ① Dissolve raw material isosorbide mononitrate in water, add mesoporous carbon (specific surface area is 1018m 2 / g, the pore volume is 0.51cm 3 / g), continuous stirring, ultrasound, after the drug enters the mesoporous carbon channel to reach equilibrium, spray drying to remove the solvent, and obtain the raw material-mesoporous carbon composite;

[0034] ②Put the raw material-mesoporous carbon composite into the fluidized bed, preheat the material to a temperature of about 34°C, and use the acetone-water (volume ratio 8:2) solution of ethyl cellulose and hydroxyethyl cellulose (solid content 5%) bottom spray coating to prepare sustained-release coated pellets, and the weight gain of the coating is 14.6% (the coating film accounts for the weight percentage of the raw material-mesoporous carbon composite);

[0035] ③Mix the sustained-release coated pellets with lactose, pregelatinized starch, crospovidone, and magnesium steara...

Embodiment 2

[0037]

[0038] Preparation Process:

[0039] ① Dissolve raw material isosorbide mononitrate in water, add mesoporous carbon (specific surface area is 1058m 2 / g, the pore volume is 0.86cm 3 / g), continuous stirring, ultrasound, after the drug enters the mesoporous carbon channel to reach equilibrium, spray drying to remove the solvent, and obtain the raw material-mesoporous carbon composite;

[0040] ②Put the raw material-mesoporous carbon composite into the fluidized bed, preheat the material to a temperature of about 34°C, and use the acetone-water (volume ratio 8:2) solution of ethyl cellulose and hydroxyethyl cellulose (solid content 5%) bottom spray coating to prepare sustained-release coated pellets, and the weight gain of the coating is 12% (the coating film accounts for the weight percentage of the raw material-mesoporous carbon composite);

[0041] ③Mix the sustained-release coated pellets with microcrystalline cellulose, sodium carboxymethyl starch, and magnesiu...

Embodiment 3

[0043]

[0044]

[0045] Preparation Process:

[0046] ① Dissolve raw material isosorbide mononitrate in water, add mesoporous carbon (specific surface area is 1018m 2 / g, the pore volume is 0.51cm 3 / g), continuous stirring, ultrasound, after the drug enters the mesoporous carbon channel to reach equilibrium, spray drying to remove the solvent, and obtain the raw material-mesoporous carbon composite;

[0047] ②Put the raw material-mesoporous carbon composite into the fluidized bed, preheat the material to a temperature of about 34°C, and use the acetone-water (volume ratio 8:2) solution of ethyl cellulose and hydroxyethyl cellulose (solid content 5%) bottom spray coating to prepare sustained-release coated pellets, and the coating weight increased to 7.5% (the coating film accounts for the weight percentage of the raw material-mesoporous carbon composite);

[0048] ③Mix the sustained-release coated pellets with microcrystalline cellulose, starch, croscarmellose sodium...

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Abstract

The invention discloses isosorbide mononitrate sustained release tablets and a preparation process thereof. According to the preparation, the sustained release aim is achieved by adopting a method for combining mesoporous carbon and membrane controlled coating. The process comprises the following steps: preparing a mesoporous carbon-isosorbide mononitrate complex; by taking ethyl cellulose as a sustained release coating material and taking hydroxyethyl cellulose as a pore-foaming agent, performing bottom-spray coating by adopting a fluidized bed to obtain sustained release coated pills; and mixing the pills with other pharmaceutically acceptable auxiliary materials, and pressing into the tablets. The sustained release tablets disclosed by the invention have the advantages that the drug release is stable, membrane aging is avoided in the storage process, the drug release stability is high, the bioavailability is high, and the preparation process is simple.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid oral preparation, in particular to a slow-release tablet containing isosorbide mononitrate and a preparation process thereof. Background technique [0002] Isosorbide mononitrate (isosorbide mononitrate) is a new generation of nitrate antiangina drug, chemical name is 1,4,3,6-dianhydro-D-sorbitol-5-nitrate, molecular formula C 6 h 9 NO 6 , the molecular weight is 191.14, and the structural formula is as follows: [0003] [0004] Isosorbide mononitrate is white needle crystal or crystalline powder, easily soluble in methanol or acetone, soluble in chloroform or water, almost insoluble in hexane. Isosorbide mononitrate has a solubility of more than 250mg / ml in each medium of pH1.0-pH6.8, which is a highly soluble drug. [0005] Isosorbide mononitrate is the main bioactive metabolite of isosorbide dinitrate. It is a nitrate drug for th...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/34A61K47/38A61K47/04A61P9/10
Inventor 王菊明
Owner 王加峰
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