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Isosorbide mononitrate sustained release tablet and preparation method thereof

A technology of isosorbide dinitrate and sustained-release tablets, which is applied in the fields of pharmaceutical formulations, medical preparations of non-active ingredients, and pill delivery, and can solve problems such as difficulty in industrial production, inability to meet tablet compression requirements, and poor fluidity of mixed powders

Active Publication Date: 2019-11-05
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the prior art, the prescription and preparation method of small-scale isosorbide mononitrate sustained-release tablets, for the large-scale 120 mg powder mixing fluidity, large difference in tablet weight, cannot meet the requirements of tablet compression, and is not easy to industrialize Production

Method used

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  • Isosorbide mononitrate sustained release tablet and preparation method thereof
  • Isosorbide mononitrate sustained release tablet and preparation method thereof
  • Isosorbide mononitrate sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053]

[0054] Preparation process: (1) mixing hypromellose, microcrystalline cellulose, mannitol, hydrogenated castor oil and silicon dioxide in the prescribed amount; (2) mixing isosorbide mononitrate: lactose (6:4) The mixed powder is passed through a 20-mesh sieve and mixed with the mixed powder described in step (1); (3) magnesium stearate is added and mixed; (4) the above-mentioned mixed powder is directly compressed into tablets, and the hardness is controlled at 90-110N.

Embodiment 2

[0056]

[0057]

[0058] Preparation process: with embodiment 1

Embodiment 3

[0060]

[0061] Preparation process: with embodiment 1

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly discloses a large-sized isosorbide mononitrate sustained release tablet and a preparation method thereof. Accordingto the prescription, the sustained release tablet is prepared from the components: isosorbide mononitrate:lactose (6:4), hydroxypropyl methylcellulose K200M, microcrystalline cellulose, mannitol, hydrogenated castor oil, silica and magnesium stearate. According to the large-sized isosorbide mononitrate sustained release tablet and the preparation method thereof, the microcrystalline cellulose, themannitol and the hydrogenated castor oil of a certain proportion are mixed to greatly improve the fluidity of mixed powder, and requirements of producing pressed tablets are met.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an isosorbide mononitrate sustained-release tablet and a preparation method thereof. Background technique [0002] Isosorbide mononitrate is a new generation of nitrate antiangina drugs, and it is the main active metabolite of isosorbide dinitrate in vivo. It is absorbed quickly after oral administration, with high absolute bioavailability and small individual differences. Its biological half-life is 4-5 hours. Ordinary preparations need to be taken 2-3 times a day, and drug resistance is likely to develop after a few weeks of oral administration. Sustained-release preparations can effectively overcome drug resistance, and isosorbide mononitrate preparations have been widely used clinically. [0003] Patent CN200410030824 discloses a slow-release tablet of isosorbide mononitrate, which is granulated by wet method. Isosorbide mononitrate is prone to explosion when heate...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/34A61K47/38A61K47/26A61P9/10
CPCA61K9/2018A61K9/2054A61K31/34A61P9/10
Inventor 张贵民寻明金冯中
Owner LUNAN PHARMA GROUP CORPORATION
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