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Trimetazidine hydrochloride bi-layer osmotic pump controlled release tablet and preparation method thereof

A technology for controlled release of trimetazidine hydrochloride and osmotic pump, which is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. problems, to maintain stability, prolong in vivo action time, and achieve good reproducibility

Active Publication Date: 2014-04-23
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention directly prepares trimetazidine hydrochloride into a double-layer osmotic pump, uses advanced membrane control technology, adjusts the tablet core and coating film prescription, and takes the osmotic pressure difference between the inside and outside of the coating film as the main force of drug release, so that the drug can reach Zero-order constant drug release, good reproducibility, and more uniform drug release rate, which can overcome the shortcomings of ordinary preparations and traditional sustained-release preparations, such as uneven drug release and poor release rate control

Method used

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  • Trimetazidine hydrochloride bi-layer osmotic pump controlled release tablet and preparation method thereof
  • Trimetazidine hydrochloride bi-layer osmotic pump controlled release tablet and preparation method thereof
  • Trimetazidine hydrochloride bi-layer osmotic pump controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0023] Tablet prescription:

[0024] Drug-containing layer

[0025] Trimetazidine Hydrochloride 35mg(29.9%)

[0026] Polyoxyethylene N80 80mg (68.4%)

[0027] Magnesium Stearate 2mg (1.7%)

[0028] booster layer

[0029] Polyoxyethylene WSR303 60mg (73.2%)

[0030] Sodium chloride 20mg (24.4%)

[0031] Magnesium Stearate 2mg (2.4%)

[0032] Coating film prescription:

[0033] Cellulose acetate 30g(88.2%)

[0034] Polyethylene glycol 4g (11.8%)

[0035] Solvent Prescription for Dissolving Coating Material

[0036] Acetone 1000mL

[0037] Distilled water 15mL

[0038] Preparation Process:

[0039] Pass the drug, polyoxyethylene and magnesium stearate in the prescribed amount of the drug-containing layer through an 80-mesh sieve, and mix evenly; pass the prescribed amount of polyoxyethylene, sodium chloride and magnesium stearate in the booster layer through an 80-mesh sieve, and mix Evenly, add the drug-containing layer granules and the booster layer granules sequen...

example 2

[0041] Tablet prescription:

[0042] Drug-containing layer

[0043] Trimetazidine Hydrochloride 35mg(40.2%)

[0044] Polyoxyethylene N80 50mg (57.5%)

[0045] Talc 2mg (2.3%)

[0046] booster layer

[0047] Polyoxyethylene WSR301 60mg (37.0%)

[0048] Sodium Chloride 100mg (61.7%)

[0049] Talc 2mg (1.3%)

[0050] Coating film prescription:

[0051] Ethylcellulose 30g (85.7%)

[0052] Polyethylene glycol 5g (14.3%)

[0053] Solvent Prescription for Dissolving Coating Material

[0054] Acetone 1000mL

[0055] Distilled water 15mL

[0056] Preparation Process:

[0057] Pass the drug, gum arabic and talcum powder in the prescription amount of the drug layer through an 80 mesh sieve, and mix evenly; pass the polyoxyethylene, sodium chloride and talcum powder in the prescription amount of the booster layer through an 80 mesh sieve, and mix evenly, and the drug-containing layer The granules and the booster layer granules are sequentially added into the 7 mm shallow concav...

example 3

[0059] Tablet prescription:

[0060] Drug-containing layer

[0061] Trimetazidine Hydrochloride 35mg (27.6%)

[0062] Sodium Alginate 90mg (70.9%)

[0063] Micronized silica gel 2mg (1.5%)

[0064] booster layer

[0065] Polyoxyethylene WSR Coagulant 60mg (83.3%)

[0066] Sodium Chloride 10mg (13.9%)

[0067] Micronized silica gel 2mg (2.8%)

[0068] Coating film prescription:

[0069] Cellulose acetate 30g (83.3%)

[0070] Hypromellose 6g (16.7%)

[0071] Solvent Prescription for Dissolving Coating Material

[0072] Acetone 1000mL

[0073] Distilled water 15mL

[0074] Preparation Process:

[0075] Pass the drug, sodium alginate, and micropowder silica gel in the prescription amount of the medicine layer through an 80-mesh sieve, and mix evenly; Layer granules and booster layer granules are sequentially added to a 7 mm shallow concave punch, and pressed to form a double-layer osmotic pump core. Dissolve cellulose acetate and hydroxypropyl methylcellulose in acet...

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Abstract

The invention provides a trimetazidine hydrochloride bi-layer osmotic pump controlled release tablet and a preparation method thereof. The osmotic pump controlled release tablet is formed by a drug-containing layer, a booster layer and a coating film, wherein the drug-containing layer comprises the following components in percentage by weight: 10-50% of trimetazidine hydrochloride, 30-80% of suspension agent and the balance of other auxiliary materials; the booster layer comprises the following components in percentage by weight: 20-90% of swelling agent, 5-70% of osmotic active substance and 0.5-5% of lubricating agent; the semipermeable coating film comprises 10-20g of semipermeable high polymer material and 1-5g of water-soluble pore-forming agent every 100 tablets. The trimetazidine hydrochloride bi-layer osmotic pump controlled release tablet can realizes constant release of drug in the body of a patient without being affected by pH value of a medium environment, enzyme, gastrointestinal motility and food, and is capable of maintaining the stability of plasma concentration of drug, reducing toxic and side effects of drug, decreasing dosing frequency and improving compliance of the patient.

Description

technical field [0001] The invention relates to a trimetazidine hydrochloride double-layer osmotic pump controlled-release tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Trimetazidine hydrochloride has anti-epinephrine, norepinephrine and vasopressin effects, can reduce vascular resistance, increase coronary and circulating blood flow, promote myocardial metabolism and myocardial energy production, and reduce myocardial oxygen consumption, thereby Improve the supply and demand balance of myocardial oxygen. Compared with other antianginal drugs, it does not cause or cause minimal hemodynamic changes, and has obvious protective effect on ischemic myocardium, so it is also called myocardial nutritional protection drug. [0003] In recent years, there have been many reports on oral preparations of trimetazidine hydrochloride, but most of them are ordinary tablets. Such as the common preparation of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K31/495A61K47/38A61P9/10
Inventor 朱志红潘卫三曲绪楷杨星钢梁静阁李淑娟于世慧
Owner SHENYANG PHARMA UNIVERSITY
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