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Improved release pharmaceutical composition of trimetazidine hydrochloride

A technology of trimetazidine hydrochloride and release composition, applied in the field of pharmaceutical preparations, can solve the problems of unstable preparation, toxic polyethylene oxide and the like, and achieve the effect of excellent quality stability

Inactive Publication Date: 2020-11-06
无锡道科森医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the use of large amounts of polyethylene oxide is toxic and accepted by regulatory agencies
Additionally, the use of large amounts of polysaccharide gum to control the release of trimetazidine hydrochloride can destabilize the formulation during stabilization

Method used

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  • Improved release pharmaceutical composition of trimetazidine hydrochloride
  • Improved release pharmaceutical composition of trimetazidine hydrochloride
  • Improved release pharmaceutical composition of trimetazidine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0057] The invention is illustrated by the following non-limiting examples, but the invention is not limited thereto:

[0058] Example 1: Compositions containing only polyethylene oxide

[0059]

[0060]

[0061] Brief description of the method of preparation:

[0062] ·Sieve trimetazidine hydrochloride, calcium hydrogen phosphate anhydrous, xanthan gum, polyethylene oxide, colloidal silicon dioxide, povidone K90 through #30 mesh and stearic acid through #40 mesh respectively magnesium.

[0063] · Mix and sieve trimetazidine hydrochloride, calcium hydrogen phosphate anhydrous, polyethylene oxide, xanthan gum, colloidal silicon dioxide, povidone K90 and stir and mix for 20 minutes.

[0064] • Lubricate the above mixture with sieved magnesium stearate for 5 minutes.

[0065] • Compress the lubricated mixture into tablets.

[0066] The dissolution rate of the above-mentioned compressed tablet was analyzed using 900ml of 0.1N hydrochloric acid as the dissolution medium...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to an improved release pharmaceutical composition of trimetazidine hydrochloride. The invention simultaneouslyrelates to a preparation method of the improved release pharmaceutical composition of trimetazidine hydrochloride. A steady improved release composition of trimetazidine hydrochloride in the inventioncomprises polyethylene oxide and polysaccharide gum as release polymers and one or more pharmaceutical excipients. The steady improved release composition of trimetazidine hydrochloride in the invention has the dissolution and release properties similar to that of products on the market, and also has excellent quality stability.

Description

technical field [0001] The technical field of pharmaceutical preparations of the present invention relates to a modified release pharmaceutical composition of trimetazidine hydrochloride. The invention also relates to a preparation method of the modified release pharmaceutical composition of trimetazidine hydrochloride. Background technique [0002] Trimetazidine hydrochloride, [1-(2,3,4-trimethoxybenzyl)-piperazine dihydrochloride], its chemical structure is as follows: [0003] [0004] Trimetazidine hydrochloride is easily soluble in water and slightly soluble in alcohol. [0005] It has two acidity coefficients (pKa) 4.32 and 8.95. It regulates ion exchange and extracellular exchange, corrects abnormal flow of ions across cell membranes caused by ischemia, and prevents cellular edema caused by hypoxia. Thus, it ensures ion pump function and sodium and potassium transmembrane flux and maintains cellular homeostasis. [0006] Trimetazidine hydrochloride is used ther...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K47/36A61K31/495A61P9/10
CPCA61K47/10A61K47/36A61K31/495A61P9/10
Inventor 克里斯蒂安·山多夫
Owner 无锡道科森医药有限公司