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Preparation method of dexketoprofen trometamol double-layer sustained-release tablets

A technology of dexketoprofen tromethamine and sustained-release tablets, which is applied in the field of medicine and can solve the problems of large fluctuation of blood drug concentration, low blood drug concentration, slow drug release of sustained-release preparations and the like

Inactive Publication Date: 2012-12-12
GUIYANG MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But clinically existing dexketoprofen trometamol preparations have a short half-life, common dosage forms need to be taken three to four times a day, and the blood drug concentration fluctuates greatly, while its sustained-release preparations release slowly and cannot rapidly release drug activity. composition, so that the maximum blood concentration is lower; and the dexketoprofen trometamol in the quick-release layer after oral administration of the double-layer sustained-release preparation developed by us dissolves quickly and relieves symptoms quickly, and the sustained-release layer then releases slowly, so that The analgesic and anti-inflammatory effect lasts for 12 hours, reduces the number of medications, improves patient compliance, and reduces adverse reactions

Method used

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  • Preparation method of dexketoprofen trometamol double-layer sustained-release tablets
  • Preparation method of dexketoprofen trometamol double-layer sustained-release tablets
  • Preparation method of dexketoprofen trometamol double-layer sustained-release tablets

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Experimental program
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Effect test

Embodiment 1

[0030] Prescription (based on 1000 tablets)

[0031] Immediate release layer:

[0032]

[0033] Sustained release layer:

[0034]

[0035]

[0036] Preparation Process

[0037] 1.1 Preparation of immediate release layer particles

[0038] Each component in the prescription was passed through a 100 mesh sieve, and the prescription amount of lactose, microcrystalline cellulose, and sodium carboxymethyl starch were thoroughly mixed, and then thoroughly mixed with dexketoprofen tromethamine, and the appropriate amount The 10% PVP K30 solution is a soft material made of a binder, granulated by a 20-mesh sieve, dried by blowing at 60°C, granulated by a 20-mesh sieve, and then mixed with magnesium stearate;

[0039] 1.2 Preparation of sustained-release layer particles

[0040] Each component in the prescription was passed through a 100 mesh sieve, and then the prescription amount of HPMC K100M, ethyl cellulose, lactose, and microcrystalline cellulose were thoroughly mixed, and then fully mixed ...

Embodiment 2

[0044] Prescription (based on 1000 tablets)

[0045] Immediate release layer:

[0046]

[0047]

[0048] Sustained release layer:

[0049]

[0050] Preparation Process

[0051] 1.1 Preparation of immediate release layer particles

[0052] Each component in the prescription was passed through a 100 mesh sieve, and the prescription amount of lactose, microcrystalline cellulose, and sodium carboxymethyl starch were thoroughly mixed, and then thoroughly mixed with dexketoprofen tromethamine, and the appropriate amount The 10% PVP K30 solution is a soft material made of a binder, granulated by a 20-mesh sieve, dried by blowing at 60°C, granulated by a 20-mesh sieve, and then mixed with magnesium stearate;

[0053] 1.2 Preparation of sustained-release layer particles

[0054] Each component in the prescription was passed through a 100 mesh sieve, and then the prescription amount of HPMC K100M, ethyl cellulose, lactose, and microcrystalline cellulose were thoroughly mixed, and then fully mixed ...

Embodiment 3

[0058] Prescription (based on 1000 tablets)

[0059] Immediate release layer:

[0060]

[0061] Sustained release layer:

[0062]

[0063] Preparation Process

[0064] 1.1 Preparation of immediate release layer particles

[0065] Each component in the prescription was passed through a 100 mesh sieve, and the prescription amount of lactose, microcrystalline cellulose, and sodium carboxymethyl starch were thoroughly mixed, and then thoroughly mixed with dexketoprofen tromethamine, and the appropriate amount The 10% PVP K30 solution is a soft material made of a binder, granulated by a 20-mesh sieve, dried by blowing at 60°C, granulated by a 20-mesh sieve, and then mixed with magnesium stearate;

[0066] 1.2 Preparation of sustained-release layer particles

[0067] Each component in the prescription was passed through a 100 mesh sieve, and then the prescription amount of HPMC K100M, ethyl cellulose, lactose, and microcrystalline cellulose were thoroughly mixed, and then fully mixed with dexk...

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Abstract

The invention relates to dexketoprofen trometamol double-layer sustained-release tablets and a preparation method thereof. The tablets are characterized in that the tablets are double-layer tablets obtained by compacting a fast-release layer and a sustained-release layer. The fast-release layer is mainly composed of dexketoprofen trometamol, a disintegrating agent, a diluent agent, an adhesive, and a lubricant. The sustained-release layer is mainly composed of dexketoprofen trometamol, a sustained-release material, a diluent agent, an adhesive, and a lubricant. An effective dosage of dexketoprofen trometamol is 10mg-120mg. A main medicine content ratio of the fast-release layer to the sustained-release layer is 1:(1-5). The invention also provides a preparation method of the dexketoprofen trometamol double-layer sustained-release tablets, and a release-degree testing method of the tablets. With the release of the fast-release part of the dexketoprofen trometamol double-layer sustained-release tablets provided by the invention, an effective blood concentration of the medicine can be reached fast. The sustained-release part is released slowly for maintaining a stable and uniform effective blood concentration. Therefore, medication times can be reduced, patient compliance can be improved, the treatment effect is stable, and toxic and side effects are low.

Description

Technical field [0001] The invention relates to a new dosage form pharmaceutical preparation in the category of non-steroidal anti-inflammatory pharmaceutical preparations, in particular to a preparation method of a dexketoprofen tromethamine double-layer sustained-release tablet, which is characterized in that it is composed of an immediate-release layer and A double-layer tablet formed by co-pressing sustained-release layers belongs to the field of medicine. Background technique [0002] The double-layer sustained-release tablet is a tablet dosage form composed of an immediate-release layer and a sustained-release layer by making one or two drugs into two parts. The immediate-release layer and the sustained-release layer can be the same drug, or two drugs with a synergistic effect. The immediate-release layer can quickly relieve or treat the disease in a short time, and reduce the harm to the patient caused by the onset of the disease. The sustained-release layer is used to ma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K31/192A61K31/195A61K47/18A61K47/32A61K47/34A61K47/36A61K47/38A61P29/00
Inventor 黄勇王永林郑林兰燕宇李勇军石凌云何峰张治蓉陈慧
Owner GUIYANG MEDICAL UNIVERSITY
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