Trimetazidine hydrochloride sustained release tablet and preparation method thereof

A technology for trimetazidine hydrochloride and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of large side effects, short effective blood drug concentration maintenance time, The effect of medicine can not be exerted smoothly and other problems, so as to achieve the effect of easy operation, reducing the frequency of taking medicine and improving compliance

Active Publication Date: 2012-01-18
GUANGZHOU BAIYUSN GUANGHUA PHARMA
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  • Summary
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  • Application Information

AI Technical Summary

Problems solved by technology

After oral administration of these two kinds of coated trimetazidine tablets, trimetazidine is rapidly absorbed, reaching the peak plasma level in less than 2 hours, and the elimination half-life is about 6 hours, taking at least three times a da

Method used

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  • Trimetazidine hydrochloride sustained release tablet and preparation method thereof

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preparation example Construction

[0031] A preparation method of trimetazidine hydrochloride sustained-release tablet, which comprises the following steps:

[0032] (1) Mixing: Stir and mix trimetazidine hydrochloride, polyoxyethylene, and dextrin in a mixer according to the formula amount;

[0033] (2) Making soft material: add ethyl cellulose liquid to the above mixed components and mix evenly to make soft material, and granulate with a 16-mesh sieve in a granulator to obtain soft drug granules;

[0034] (3) Drying: the above-mentioned soft medicine granules are dried in a drying oven;

[0035] (4) Tablet compression: the above-mentioned dried granules are uniformly mixed with magnesium stearate, and compressed into tablets to obtain sustained-release tablets.

Embodiment 1

[0037] The following formula, according to the above-mentioned preparation method, is made into 2000 trimetazidine hydrochloride sustained-release tablets, and each sustained-release tablet finally obtained weighs about 170mg:

[0038] Trimetazidine Hydrochloride 40g

[0039] Polyoxyethylene 100g

[0040] Dextrin 200g

[0041] 3% ethyl cellulose solution 60g

[0042] Magnesium stearate 3g.

Embodiment 2

[0044] The following formula, according to the above-mentioned preparation method, is made into 2000 trimetazidine hydrochloride sustained-release tablets, and each sustained-release tablet finally obtained weighs about 170mg:

[0045] Trimetazidine Hydrochloride 40g

[0046] Polyoxyethylene 150g

[0047] Dextrin 150g

[0048] 5% ethyl cellulose solution 80g

[0049] Magnesium stearate 3g.

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Abstract

The invention belongs to the field of sustained release medicament preparations, and particularly relates to a trimetazidine hydrochloride sustained release tablet and a preparation method thereof. The trimetazidine hydrochloride sustained release tablet is prepared from 40 to 45 parts of trimetazidine hydrochloride, 100 to 200 parts of polyoxyethylene, 100 to 200 parts of dextrin, 60 to 100 parts of 3-10 percent ethyl cellulose solution and 3 to 5 parts of magnesium stearate through material mixing, soft material preparing, drying, tabletting and other steps. In the trimetazidine hydrochloride sustained release tablet, the polyoxyethylene serves as an auxiliary material, and the sustained release tablet is prepared from the medicaments by a method of direct tabletting or tabletting aftergranulating. The drug dissolution of the trimetazidine hydrochloride sustained release tablet reaches about 90 percent 6 hours later, so the sustained release tablet is only required to be taken twice a day; therefore, the sustained release tablet has the advantages of releasing drug slowly and uniformly to reduce release rate and postpone peak time, reducing the number of administration times per day, improving the compliance of patients to the medicament and the like. Furthermore, the preparation method of the invention is simple and easy to operate.

Description

[0001] technical field [0002] The invention belongs to the field of sustained-release pharmaceutical preparations, and in particular relates to a trimetazidine hydrochloride sustained-release tablet and a preparation method thereof. [0003] Background technique [0004] Angina is the more common type of ischemic heart disease. According to reports, about 7.2 million people in the United States suffer from angina pectoris, and it is increasing at a rate of 350,000 people per year. 50-75% of the total number of deaths. In my country, with the improvement of people's living standards, the change of lifestyle and the acceleration of the pace of life, the incidence of angina pectoris is increasing year by year. Taking Beijing, where the incidence rate ranks first in the country, as an example, the fatality rate of angina pectoris with complications accounted for 13% of the total population deaths in 2003, and it is still on the rise, approaching the level of European and Am...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/495A61K47/38A61P9/10
Inventor 李翼鹏
Owner GUANGZHOU BAIYUSN GUANGHUA PHARMA
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