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Trimetazine dihydrochloride sustained-release tablet and preparation method thereof

A technology of trimetazidine hydrochloride and sustained-release tablets, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of poor stability and easy degradation of trimetazidine hydrochloride tablets. and other problems, to achieve the effect of stable process, stable dissolution and guaranteed stability

Inactive Publication Date: 2019-06-21
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this application, trimetazidine hydrochloride tablets have poor stability and are easily degraded.

Method used

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  • Trimetazine dihydrochloride sustained-release tablet and preparation method thereof
  • Trimetazine dihydrochloride sustained-release tablet and preparation method thereof
  • Trimetazine dihydrochloride sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] 1. Prescription

[0050]

[0051]

[0052] Preparation Process

[0053] (1) Mix the prescribed amount of trimetazidine hydrochloride, calcium hydrogen phosphate and polyvinylpyrrolidone evenly.

[0054] (2) Add appropriate amount of purified water for wet granulation and fluidized bed drying.

[0055] (3) Mix the granules prepared in step (2) with prescription quantities of hypromellose E50 and hypromellose E4M, add magnesium stearate and mix uniformly;

[0056] (4) Compressing the mixture obtained in step (3) into tablets and coating with non-functionality.

[0057] The sample that embodiment 1 obtains is put in the phosphate buffer saline solution of pH6.8 and measures release rate as shown in the table below:

[0058]

[0059] Investigating the release curve of the trimetazidine hydrochloride sustained-release tablets obtained in Example 1, it can be seen that using a mixture of hypromellose with different viscosities as the matrix material can better con...

Embodiment 2

[0061] prescription:

[0062]

[0063]

[0064] Preparation Process:

[0065] (1) Mix the prescribed amount of trimetazidine hydrochloride, calcium hydrogen phosphate and polyvinylpyrrolidone evenly.

[0066] (2) Add appropriate amount of purified water for wet granulation and fluidized bed drying.

[0067] (3) Mix the granules prepared in step (2) with prescription quantities of hypromellose E50 and hypromellose E4M, add magnesium stearate and mix uniformly;

[0068] (4) Compressing the mixture obtained in step (3) into tablets and coating with non-functionality.

[0069] The sample that embodiment 2 is obtained is put in the phosphate buffer saline buffer solution of pH6.8 and measures release rate and is:

[0070]

[0071] Investigating the release curves of the trimetazidine hydrochloride sustained-release tablets obtained in Example 2, it can be seen that different types of binders have little effect on the release of trimetazidine hydrochloride sustained-releas...

Embodiment 3

[0076] 1. Prescription

[0077]

[0078] Preparation Process

[0079] (1) Mix the prescription amount of trimetazidine hydrochloride, calcium hydrogen phosphate and binder evenly.

[0080] (2) Add appropriate amount of purified water for wet granulation and fluidized bed drying.

[0081] (3) Mix the granules prepared in step (2) with prescription quantities of hypromellose E50 and hypromellose E4M, add magnesium stearate and mix uniformly;

[0082] (4) Compressing the mixture obtained in step (3) into tablets and coating with non-functionality.

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Abstract

The invention discloses a trimetazine dihydrochloride sustained-release tablet which comprises trimetazidine dihydrochloride, a sustained-release matrix material, a filler, a binding agent and a lubricating agent. The sustained-release matrix material is a mixture of hydroxypropyl methyl cellulose with different viscosity. By the arrangement, the initial burst release of trimetazidine dihydrochloride in the early stage is stable, shortcomings of poor stability and easy degradation of trimetazidine dihydrochloride tablet are overcome, and the stability of the trimetazine dihydrochloride tabletis improved.

Description

technical field [0001] The application belongs to the field of pharmaceutical preparations, and more specifically, the application relates to a trimetazidine hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Trimetazidine (Trimetazidine) chemical name is 1-(2,3,4-trimethoxybenzyl) piperazine, is the first 3-ketoacyl-CoA thiolase inhibitor (3-KAT), it It can inhibit the oxidation of fatty acid (FFA), stimulate the oxidation of glucose, and have a protective effect against myocardial ischemic cells to a certain extent. In recent years, trimetazidine hydrochloride has been widely used in the preventive treatment of angina pectoris and the auxiliary symptomatic treatment of vertigo and tinnitus. [0003] Trimetazidine hydrochloride sustained-release tablets currently on the market abroad, trade name Vastarel MR, reaches the maximum concentration after 5 hours of oral administration, and the blood concentration is not lower th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/495A61K47/38A61P9/10A61P27/16
Inventor 王亚军张震黄俊王松笛杨波冯小路
Owner WUHAN WUYAO SCI & TECH
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