Trimetazidine dihydrochloride sustained control release pellet and preparation method thereof

A technology of trimetazidine hydrochloride and pellets, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of different uniformity of drug content, difficulty in controlling blood drug concentration, Unable to achieve the expected curative effect and other problems, to achieve the effect of small difference in bioavailability, uniform absorption rate in the body, scientific and reasonable formula and structure

Inactive Publication Date: 2011-07-27
王国栋
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still some deficiencies in the production process: one is to use the extrusion spheronization method to prepare micropills, and the particles prepared by this method will have different sizes and poor roundness; pellets due to their differences in bulk density and volume
The uniformity of the drug content is different, so it is difficult to control the blood drug concentration after taking it, and the expected curative effect cannot be achieved; the third is that the process takes a long time to operate, the procedure is complicated, and the cost is high

Method used

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  • Trimetazidine dihydrochloride sustained control release pellet and preparation method thereof

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Effect test

Embodiment 1-5

[0054]

[0055] Embodiments 1-5 are a kind of sustained and controlled release pellets of trimetazidine hydrochloride and preparation method thereof, the sustained and controlled release pellets involved in each embodiment have a diameter of 480-1700um, and the percentage of drug contained in the pellets is 5% —40%.

[0056] The pellet-like structure involved includes a blank pellet core, a trimetazidine hydrochloride drug layer, and a sustained-release coating layer from the inside to the outside.

[0057] The raw materials for making the active ingredients of the blank pellet core include a diluent, a binder and a wetting agent, wherein the diluent is selected from one of starch, sucrose and microcrystalline cellulose, or a mixture of at least two.

[0058] The raw material that makes coating layer active ingredient comprises retarder, plasticizer and wetting agent, wherein plasticizer is selected from a kind of in dibutyl sebacate, triglyceride or triethyl citrate; The ...

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Abstract

The invention relates to trimetazidine dihydrochloride sustained control release pellet and a preparation method thereof. The sustained control release pellet structurally comprises a blank pellet core, a trimetazidine dihydrochloride medicine layer and a sustained control release coating layer from inside to outside; the preparation method comprises the following steps: preparing the blank pellet core by a centrifugal coating pelletizer, putting the blank pellet core in the centrifugal coating pelletizer under a motion state, then spraying mixed liquor of adhesive and wetting agent by a spray gun until the blank pellet core is wetted, uniformly spreading the raw trimetazidine dihydrochloride on the wetted blank pellet core through a powder supplying device to obtain a medicine-containing pellet, and carrying out sustained control release coating on the exterior of the medicine-containing pellet, thus obtaining the trimetazidine dihydrochloride sustained control release pellet. The invention is suitable for preparing the trimetazidine dihydrochloride sustained control release pellet, the preparation process is simple, and a prepared pellet product is scientific and reasonable in structure, uniform in granularity and good in release degree.

Description

technical field [0001] The invention relates to a sustained and controlled release pellet preparation of trimetazidine hydrochloride, in particular to a sustained and controlled release pellet of trimetazidine hydrochloride and a preparation method thereof. Background technique [0002] Trimetazidine hydrochloride prevents the decrease of intracellular ATP level by maintaining the energy metabolism of cells in hypoxic or local ischemic environment, thereby ensuring the normal function of the ion pump and the normal operation of transmembrane sodium-potassium, and maintaining the stability of the intracellular environment . At present, trimetazidine hydrochloride has been widely used clinically for the preventive treatment of angina pectoris attack, as well as the auxiliary symptomatic treatment of vertigo and tinnitus. It has the advantages of significant curative effect, can be combined with other drugs, and has few adverse reactions. [0003] Commercially available trimet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/22A61K9/52A61K31/495A61K47/32A61K47/36A61K47/38A61P9/10
Inventor 程彦发姜建国王国振陈品英王翠敏
Owner 王国栋
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