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Trimetazidine hydrochloride sustained-release capsule and preparation method thereof

A technology of trimetazidine and sustained-release capsules, which is applied in the field of medicine and can solve problems such as too many process parameter control points, stability to be verified, and unfavorable industrialization.

Inactive Publication Date: 2015-04-01
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method is cumbersome, the process is complicated, the preparation cycle is long, and the process parameter control points are too many in the preparation process, which is not conducive to subsequent industrialization
Invention patent CN102657608A discloses a trimetazidine composition and its preparation method. Its dosage form is injection, and there is no sustained-release dosage form with high safety and good patient compliance, and the stability of the dosage form needs to be verified
Invention patent CN102885795A also discloses a trimetazidine hydrochloride sustained-release tablet and its preparation method. After the sustained-release tablet is compressed, a subsequent coating operation is required. In view of the instability of trimetazidine hydrochloride under light conditions Features, the subsequent coating process is necessary for sustained-release tablets, but it also increases the production cost and prolongs the production cycle

Method used

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  • Trimetazidine hydrochloride sustained-release capsule and preparation method thereof
  • Trimetazidine hydrochloride sustained-release capsule and preparation method thereof
  • Trimetazidine hydrochloride sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025] Preparation Process:

[0026] (1) Crushing the trimetazidine hydrochloride raw material through a 100-mesh sieve;

[0027] (2) Prepare 5% povidone K30 aqueous solution;

[0028] (3) Mix the pulverized raw materials with the prescribed amount of hypromellose K15M and microcrystalline cellulose, and then use the above-mentioned binder to make a soft material;

[0029] (4) Add the soft material to the extrusion spheronizer to prepare pellets;

[0030] (5) Dry the pellets in an oven at 50°C until the moisture content is less than 3%, and then pass through a 30-mesh sieve;

[0031] (6) Filling capsules.

Embodiment 2

[0033]

[0034] Preparation Process:

[0035] (1) Crushing the trimetazidine hydrochloride raw material through a 100-mesh sieve;

[0036] (2) Prepare 5% povidone K30 aqueous solution;

[0037] (3) Mix the pulverized raw materials with the prescribed amount of hypromellose K4M and lactose, and then use the above-mentioned binder to make a soft material;

[0038] (4) Add the soft material to the extrusion spheronizer to prepare pellets;

[0039] (5) Dry the pellets in an oven at 50°C until the moisture content is less than 3%, and then pass through a 30-mesh sieve;

[0040] (6) Filling capsules.

Embodiment 3

[0042]

[0043] Preparation Process:

[0044] (1) Crushing the trimetazidine hydrochloride raw material through a 100-mesh sieve;

[0045] (2) Prepare 5% povidone K30 aqueous solution;

[0046] (3) Mix the pulverized raw materials with the prescribed amount of sodium carboxymethyl cellulose and sucrose, and then use the above-mentioned binder to make a soft material;

[0047] (4) Add the soft material to the extrusion spheronizer to prepare pellets;

[0048] (5) Dry the pellets in an oven at 50°C until the moisture content is less than 3%, and then pass through a 30-mesh sieve;

[0049] (6) Filling capsules.

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Abstract

The invention discloses a trimetazidine hydrochloride sustained-release capsule and a preparation method thereof, belonging to the technical field of medicines. The sustained-release capsule is prepared by filling sustained-release pellets containing trimetazidine in capsules, wherein the sustained-release pellets are a framework control preparation. The trimetazidine hydrochloride sustained-release capsule prepared by the preparation method is simple in process and low in cost. As the capsule is in a multiunit control release system of drug, the user does not need to worry about abrupt release of drug. Compared with preparations such as sustained release tablets, the trimetazidine hydrochloride sustained-release capsule is safe and reliable in medication and high in medication compliance.

Description

technical field [0001] The invention relates to a sustained-release dosage form of an antiangina pectoris cardiovascular drug and a preparation method thereof, in particular to a trimetazidine hydrochloride sustained-release capsule and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Angina pectoris is a common cardiovascular disease, which is caused by coronary artery atherosclerosis and stenosis, coronary artery insufficiency, temporary myocardial ischemia and hypoxia, and a group of comprehensive symptoms with precordial pain as the main clinical manifestation. It is a kind of coronary heart disease with the highest incidence rate, which seriously threatens the health and life of human beings. It is mainly divided into stable angina and unstable angina. Angina pectoris can occur at any time in 24 hours, but it is mostly from early morning to morning, and variant angina pectoris often occurs regularly at night. Th...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/495A61P9/10A61P27/16A61P1/08
Inventor 马莉刁媛媛马苏峰
Owner 万全万特制药(厦门)有限公司
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