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Nifedipine sustained release tablets preparation method

A technology for nifedipine and nifedipine, which is applied in the field of preparation of nifedipine sustained-release tablets, can solve the problems of complicated process, unsatisfactory drug effect of nifedipine sustained-release tablets, and difficulty in industrialization, and achieves technological operation. Simple, improved clinical efficacy, easy-to-control effects

Inactive Publication Date: 2008-06-04
SINOPHARM GUANGDONG GLOBAL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the prior art, when nifedipine is prepared into a sustained-release preparation, the process is complicated, it is difficult to industrialize, and the drug effect of the prepared nifedipine sustained-release tablet is not satisfactory

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The preparation method of nifedipine slow-release tablet described in the present embodiment, at first nifedipine and ethyl vitamin by 1: 1, nifedipine and acrylic resin I add appropriate amount of water as wetting agent by the ratio of 1: 1 Make 1200μm skeleton particles; secondly, heat and melt the PEG4000 used for nifedipine at a ratio of 1:1 to make a solid dispersion, and then crush the solid dispersion into 1600μm particles; finally, combine the skeleton particles and the dissolution particles Mix at a ratio of 1:8, add an appropriate amount of lubricant magnesium stearate, and compress into tablets. The loading capacity of the main drug is 30mg per tablet.

Embodiment 2

[0023] The preparation method of nifedipine slow-release tablet described in the present embodiment, at first with nifedipine and ethyl vitamin by 1:10, nifedipine and acrylic resin I by the ratio of 1:20 and add appropriate amount of ethanol as wetting 1200-mesh skeleton-type granules; secondly, the PEG4000 used for nifedipine was heated and melted at a ratio of 1:20 to make a solid dispersion, and then the solid dispersion was crushed into 1800 μm particles; finally, the above-mentioned skeleton-type granules were mixed with 14 The mesh granules are mixed at a ratio of 1:6, an appropriate amount of lubricant magnesium stearate is added, and compressed into tablets. The loading capacity of the main drug is 25mg per tablet.

Embodiment 3

[0025] The preparation method of nifedipine slow-release tablet described in the present embodiment, at first nifedipine and ethyl vitamin are mixed by 1: 80 nifedipine and acrylic resin II, acrylic resin III (both ratio is 1: 1) According to the ratio of 1:100 and adding an appropriate amount of water as a wetting agent, 1000μm skeleton particles are made; secondly, the PEG4000 used for nifedipine is heated and melted at a ratio of 1:80 to make a solid dispersion, and then solid dispersion The body is crushed into 1000μm particles; finally, the skeleton type particles and the dissolution type particles are mixed at a ratio of 1:10, and an appropriate amount of lubricant talcum powder and micropowder silica gel is added, and pressed into tablets. The loading capacity of the main drug is 20mg per tablet.

[0026] Example 3

[0027] The preparation method of nifedipine slow-release tablet described in this embodiment, firstly nifedipine and ethyl vitamin are mixed by 1:100 nife...

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Abstract

The invention discloses a preparation method of a sustained release tablet of nifedipine: (1) nifedipine and ethyl vitamin are prepared into frame type particles according to the ratio of 1:0.1-100, and nifedipine and acrylics acid resin are prepared into frame type particles according to the ratio of 1:0.1-100; (2) nifedipine and PEG are heated to be melted according to the ratio of 1:0.1-100 and then are prepared into solid dispersion, and then the solid dispersion is crushed into particles; (3) the frame type particles are mixed with the particles described in the (2) step according to the ratio of 1:1-10, and then are compressed into tablets. The preparation method overcomes the disadvantage of the traditional technique of complexity and being difficult to be industrialized; the technique of the invention is simple in technique and easy to be controlled, and the sustained release tablet of nifedipine prepared by the preparation method can remarkably reduce the adverse reaction of the medicine, enhance the compliance of patients as well as improve clinical curative effect.

Description

technical field [0001] The invention belongs to the field of medicine preparation, and in particular relates to a preparation method of nifedipine sustained-release tablets. Background technique [0002] Nifedipine is a blood pressure lowering drug, which is a representative drug among calcium channel blockers. At present, the usual dosage forms of nifedipine on the market are tablets or capsules, and the drug content of each tablet / grain is 5mg or 10mg. Major side effects, for example, high blood concentration of the drug can easily cause headache, dizziness, palpitation, rapid heartbeat, flushing of the face and edema of the lower extremities. For these shortcomings of nifedipine, it can be made into sustained-release preparations, so that the drug will not be rapidly absorbed by the body after entering the human body and play a role, but will be released slowly and evenly at a certain speed, so that the drug effect is moderate and sustained. long time. Therefore, makin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/32A61K31/4422A61P9/12
Inventor 向飞军郭静李少珊李凤银林碧珊高永坚
Owner SINOPHARM GUANGDONG GLOBAL PHARMA CO LTD
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