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Bezafibrate slow release pharmaceutical composition

A slow-release drug, the technology of bezafibrate, which is applied in the field of medicine, can solve the problems of large release differences and achieve the effects of low cost, easy industrialization, and simple composition of prescriptions

Inactive Publication Date: 2013-04-17
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The object of the present invention is to provide a kind of bezafibrate sustained-release pharmaceutical composition, by controlling the particle diameter of raw material to prepare large scale sustained-release tablet, this sustained-release pharmaceutical composition does not need functional controlled-release coating to regulate drug release, the obtained The drug release property of the pharmaceutical composition is stable, which solves the problems of easy burst release in the early stage after taking the drug and large release differences between tablets at each release point

Method used

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  • Bezafibrate slow release pharmaceutical composition
  • Bezafibrate slow release pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Prescription: Bezafibrate 400g

[0042] Hypromellose 50g

[0043] Starch 80g

[0044] PEG 4000 20g

[0045] Talc powder 3g

[0046] Preparation method: pass bezafibrate through 40 mesh and 80 mesh sieves, screen the part with a particle size of 40 mesh to 80 mesh, mix it with hypromellose, starch and PEG 4000 according to the above ratio, add the above ratio of talc powder and mix Evenly, directly compress into tablets, compress 1000 tablets, weigh an appropriate amount of Eudragit L30D-55, use an appropriate amount of 95% ethanol to make a coating solution with a weight concentration of 5%, and perform enteric coating coating. After coating, enteric coating accounts for the tablets 3% of the weight.

Embodiment 2

[0048] Prescription: Bezafibrate 400g

[0049] Starch 8g

[0050] Hydroxypropyl Cellulose 40g

[0051] Lactose 82g

[0052] PEG6000 30g

[0053] Magnesium stearate 0.5g

[0054] Preparation method: pass bezafibrate through 40 mesh and 80 mesh sieves, screen the part with a particle size of 40 mesh to 80 mesh, mix it with hydroxypropyl cellulose, lactose, starch and PEG 6000 according to the above ratio, add the above ratio hard Magnesium fatty acid was mixed evenly, and directly compressed into 1000 tablets. Weighed an appropriate amount of Eudragit L30D-55, added an appropriate amount of 95% ethanol to prepare a coating solution with a weight concentration of 5%, and performed enteric coating. The dissolved coating accounts for 1% of the tablet weight.

Embodiment 3

[0056] Prescription: Bezafibrate 400g

[0057] Hypromellose 25g

[0058] Hydroxypropyl Cellulose 15g

[0059] Lactose 100g

[0060] PEG6000 25g

[0061] Magnesium Stearate 1g

[0062] Preparation method: pass bezafibrate through 40-mesh and 80-mesh sieves, screen the part with a particle size of 40 mesh to 80 mesh, and mix it with hypromellose, hydroxypropyl cellulose, lactose, and PEG 6000 in the above ratio evenly , add the above ratio of magnesium stearate and mix well, directly compress 1000 tablets, weigh an appropriate amount of Eudragit L30D-55, add an appropriate amount of 95% ethanol, and make a coating solution with a weight concentration of 5% for enteric coating , after coating, the enteric coating accounts for 0.5% of the tablet weight.

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Abstract

The invention relates to a bezafibrate slow release pharmaceutical composition which comprises a bezafibrate material which accounts for 60% of total weight of the slow release pharmaceutical composition and has the particle size of 40-80 meshes, more than one slow release auxiliary material, and more than one pharmaceutically acceptable non-slow release auxiliary material. The bezafibrate slow release pharmaceutical composition prepared is stable in medicine releasing property, and solves the problem that the medicine is easy to release abruptly in the early stage of medicine delivery and the release differences among releasing spot films are greater.

Description

technical field [0001] The invention relates to a sustained-release pharmaceutical composition in the technical field of medicine, in particular to a sustained-release pharmaceutical composition of bezafibrate. Background technique [0002] Sustained-release preparations refer to a new class of preparations that purposely control the release of drugs to achieve a reasonable therapeutic effect. It enables the human body to obtain a stable therapeutic blood drug concentration and optimizes the therapeutic dose. Compared with ordinary oral preparations, it can stabilize blood concentration, avoid peak and valley phenomena, and help reduce adverse drug reactions; reduce the number of medications, improve patient compliance, and be convenient to use; it can reduce the total dose of medication, and can be compared with conventional doses. Smaller doses achieve the curative effect of conventional doses, and reduce the number of times of taking medicines. [0003] Bezafibrate belon...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K9/28
Inventor 熊春德
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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