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Orally taken control released trimetazidine medicine composition

A technology for trimetazidine and controlled-release drugs, applied in the field of oral trimetazidine pharmaceutical compositions, can solve the problems of incomplete drug release, prone to time lag, and incomplete utilization of dosage, and achieve plasma drug concentration Smooth, effective and safe effects

Inactive Publication Date: 2007-03-21
GUANGZHOU PUIS PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug dissolution rate of this pharmaceutical composition is only about 75% in 16 hours in vitro, and incomplete drug release will inevitably lead to incomplete utilization of the administered dose
In addition, in the storage system, the drug diffuses from the core material, passes through the rate-controlling membrane, and enters the surrounding environment. Controlling drug release through such a system is prone to time lag.

Method used

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  • Orally taken control released trimetazidine medicine composition
  • Orally taken control released trimetazidine medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] (1) Drug-containing layer

[0097] Trimetazidine Hydrochloride 35g

[0098] Polyoxyethylene 50g

[0099] Hypromellose 4g

[0100] Magnesium stearate 0.6g

[0101] (2) booster layer

[0102] Polyoxyethylene 30g

[0103] Sodium chloride 20g

[0104] Hypromellose 2g

[0105] Iron oxide red 0.5g

[0106] Magnesium stearate 0.5g

[0107] Makes 1000 pieces

[0108] (3) Prescription of coating solution (1000 tablets dosage)

[0109] Cellulose acetate 10g

[0110] Polyethylene glycol 0.5g

[0111] Proper amount of acetone

[0112] Anhydrous ethanol amount

[0113] Preparation:

[0114] 1. Sieve, mix and granulate the raw and auxiliary materials of the drug-containing layer and the booster layer according to the above-mentioned prescription amount, and press the drug-containing layer and the booster layer into a double-layer tablet core by two-time tablet compression technology;

[0115] 2. Preparation of coating solution: mix acetone and absolute ethanol, then ad...

Embodiment 2

[0119] (1) Drug-containing layer

[0120] Trimetazidine Hydrochloride 60g

[0121] Sodium chloride 4g

[0122] Polyoxyethylene 80g

[0123] Hypromellose 6g

[0124] Magnesium Stearate 2g

[0125] 75% ethanol appropriate amount

[0126] (2) booster layer

[0127] Polyoxyethylene 45g

[0128] Sodium chloride 35g

[0129] Hypromellose 4g

[0130] Iron oxide 1g

[0131] Magnesium Stearate 1g

[0132] 75% ethanol appropriate amount

[0133] Makes 1000 pieces

[0134] (3) Prescription of coating solution (1000 tablets dosage)

[0135] Cellulose acetate 15g

[0136] Polyethylene glycol 1g

[0137] Proper amount of acetone

[0138]Anhydrous ethanol amount

[0139] Preparation:

[0140] 1. Sieve and mix the raw and auxiliary materials of the drug-containing layer and the booster layer according to the above-mentioned prescription quantities, and then mix wet granulation, and use the two-time compression technology to compress the drug-containing layer and the booster l...

Embodiment 3

[0143] (1) Drug-containing layer

[0144] Trimetazidine Hydrochloride 70g

[0145] Sodium chloride 5g

[0146] Polyoxyethylene 104g

[0147] Hypromellose 8g

[0148] Magnesium Stearate 2g

[0149] Silica 2g

[0150] (2) booster layer

[0151] Polyoxyethylene 58g

[0152] Sodium chloride 44g

[0153] Hypromellose 6g

[0154] Iron oxide red 1g

[0155] Magnesium Stearate 1g

[0156] Makes 1000 pieces

[0157] (3) Prescription of coating solution (1000 tablets dosage)

[0158] Cellulose acetate 30g

[0159] Polyethylene glycol 1.5g

[0160] Proper amount of acetone

[0161] Preparation method: with embodiment 1.

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PUM

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Abstract

The present invention relates to one kind of orally taken control released trimetazidine medicine composition and its preparation process. The trimetazidine medicine composition consists of trimetazidine or its physiologically acceptable salt in effective dosage and pharmaceutically acceptable medicine excipient capable of reaching release controlling osmotic pump effect. The medicine excipient is one or several selected from osmotic pressure active matter, permeation assistant, diluent, colorant, lubricant, moistener or adhesive, filming material, pore creating agent, plasticizer and solvent.

Description

technical field [0001] The invention relates to an oral trimetazidine medicinal composition controlled by an osmotic pump and a preparation method thereof. technical background [0002] Trimetazidine mainly inhibits free fatty acid metabolism, increases glucose metabolism, and increases myocardial energy supply. It is an anti-ischemic drug. The results of a number of clinical trials show that trimetazidine can reduce the symptoms of angina pectoris, improve exercise tolerance, and play an important role in the treatment of angina pectoris and ischemic cardiomyopathy. It has significant curative effect, can be used in combination with other drugs, and has few adverse reactions. The advantage is that it is a safe and effective drug for treating coronary heart disease. For stable angina pectoris, trimetazidine can be used alone for patients with mild angina pectoris to reduce the number of attacks of angina pectoris and the dosage of nitroglycerin in patients with coronary hea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/495A61K47/34A61P9/10A61K47/10A61K47/38
Inventor 贝庆生
Owner GUANGZHOU PUIS PHARMA FACTORY
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