Isosorbide mononitrate sustained release tablet and preparation method thereof

A technology of isosorbide dinitrate and sustained-release tablets, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, and pill delivery, etc., and can solve the problems of uneven mixing of isosorbide mononitrate, stickiness, and high humidity requirements.

Active Publication Date: 2012-09-26
北京均大检测科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Existing studies (Miao Yushan et al., Development of Isosorbide Mononitrate Sustained-release Tablets and Determination of Release and Absorption Fraction, Jiangsu Pharmaceutical and Clinical Research, Volume 6, No. 2, 1998, page 2) show that mononitrate If isosorbide sustained-release tablets do not contain PVP, after 12 months of storage, crystal spots will appear on one surface, the hardness will become smaller, and the friability will become larger, while the tablets containing PVP overcome the above shortcomings; All have strong hygroscopicity. In the case of high humidity, isosorbide mononitrate is unevenly mixed and sticky when tableting, which seriously affects the appearance of the tablet and the uniformity of the content. Therefore, the humidity requirement during production is relatively high. high

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
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Effect test

Embodiment 1

[0053] Isosorbide mononitrate 60g, hypromellose K4M 105g, microcrystalline cellulose 130.5g, silicon dioxide 3g, sodium lauryl sulfate 1g. A total of 1000 pieces were prepared.

[0054] 1) Isosorbide mononitrate is passed through a 30-mesh sieve and mixed with half of the prescription amount of hypromellose, then crushed through an 80-mesh sieve to obtain a mixed powder of isosorbide mononitrate and hypromellose, and the remaining hypromellose Pass through a 80-mesh sieve and set aside.

[0055] 2) Mix the mixed powder of isosorbide mononitrate and hypromellose with the remaining hypromellose and the prescribed amount of microcrystalline cellulose for 20 minutes, then add the prescribed amount of silicon dioxide and sodium lauryl sulfate and mix again 10 minutes.

[0056] 3) The powder is directly compressed into tablets to obtain plain tablets;

[0057] 4) Take half of the plain tablets for coating, take the prescribed amount of film coating premix Opadry II, slowly add it...

Embodiment 2

[0059] Isosorbide mononitrate 60g, hypromellose K4M 105g, microcrystalline cellulose 130.5g, silicon dioxide 3g, sodium lauryl sulfate 1.5g. A total of 1000 pieces were prepared.

[0060] Prepare with reference to the method of Example 1.

Embodiment 3

[0062] Isosorbide mononitrate 60g, hypromellose K4M 105g, microcrystalline cellulose 130.5g, silicon dioxide 3g, sodium lauryl sulfate 2g. A total of 1000 pieces were prepared.

[0063] Prepare with reference to the method of Example 1.

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PUM

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Abstract

The invention belongs to the field of pharmaceutic preparation, and particularly relates to an isosorbide mononitrate sustained release tablet and a preparation method thereof. The tablet prescription of the sustained release tablet in the application comprises the following components: isosorbide mononitrate, hydroxypropyl methylcellulose K4M, microcrystalline cellulose, silicon dioxide and sodium dodecyl sulfate. The isosorbide mononitrate sustained release tablet prepared by the components has better stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a stable 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 now isosorbide mononitrate sustained-release tablets have been widely used in clinical practice. [0003] Existing studies (Miao Yushan et al., Development of Isosorbide Mononitrate Sustained-release Tablets and Determinat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/28A61K31/34A61K47/38A61P9/10
Inventor 张信中张洪
Owner 北京均大检测科技有限公司
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