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A kind of trimetazidine hydrochloride sustained-release tablet and preparation method thereof

A technology of 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. Release effects, unstable quality of sustained-release tablets, etc., to achieve the effects of reducing side effects, improving drug safety, and reducing the number of medications

Active Publication Date: 2022-05-13
HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The invention overcomes the disadvantages of unstable quality of sustained-release tablets in the prior art, large changes in drug release rate in media with different pH values, and inability to really achieve sustained-release effects

Method used

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  • A kind of trimetazidine hydrochloride sustained-release tablet and preparation method thereof
  • A kind of trimetazidine hydrochloride sustained-release tablet and preparation method thereof
  • A kind of trimetazidine hydrochloride sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1. The composition of the prescription of trimetazidine hydrochloride sustained-release tablets: the specification is 35 mg, and the prescription quantity is 1000 tablets.

[0040]

[0041] Preparation:

[0042] Pretreatment: pass the raw and auxiliary materials through a 40-mesh sieve for pretreatment; mixing: weigh the prescription amount of trimetazidine hydrochloride and calcium hydrogen phosphate dihydrate and mix them evenly in a hopper mixer, then mix hypromellose, carbopol Add 974P and Eudragit L100 to the above materials and mix evenly. The above materials and colloidal silicon dioxide are mixed twice through a 30-mesh sieve and placed in a hopper mixer. Magnesium stearate is added and mixed evenly to obtain a total blended powder; tableting : Put the mixed powder in a rotary tablet press for tableting to obtain plain tablets; Coating: Put the plain tablets in a high-efficiency coating machine for film coating.

Embodiment 2

[0043] Example 2. The composition of the prescription of trimetazidine hydrochloride sustained-release tablets: the specification is 35 mg, and the prescription quantity is 1000 tablets.

[0044]

[0045] The preparation method is as follows:

[0046]Pretreatment: pass the raw and auxiliary materials through a 40-mesh sieve for pretreatment; mixing: weigh the prescription amount of trimetazidine hydrochloride and calcium hydrogen phosphate dihydrate and mix them evenly in a hopper mixer, then mix hypromellose, carbopol Mu 934P and Eudragit S100 were added to the above materials and mixed evenly. The above materials were mixed with colloidal silicon dioxide through a 30-mesh sieve twice, then placed in a hopper mixer, and magnesium stearate was added to mix evenly to obtain a total blended powder; tableting : Put the mixed powder in a rotary tablet press for tableting to obtain plain tablets; Coating: Put the plain tablets in a high-efficiency coating machine for film coatin...

Embodiment 3

[0047] Example 3. The composition of the prescription of trimetazidine hydrochloride sustained-release tablets: the specification is 35 mg, and the prescription quantity is 1000 tablets.

[0048]

[0049]

[0050] The preparation method is as follows:

[0051] Pretreatment: pass the raw and auxiliary materials through a 40-mesh sieve for pretreatment; mixing: weigh the prescription amount of trimetazidine hydrochloride and calcium hydrogen phosphate dihydrate and mix them evenly in a hopper mixer, then mix hypromellose, carbopol Add 974P and Eudragit S100 to the above materials and mix evenly. The above materials and colloidal silicon dioxide are mixed twice through a 30-mesh sieve and placed in a hopper mixer. Magnesium stearate is added and mixed evenly to obtain a total blended powder; tableting : Put the mixed powder in a rotary tablet press for tableting to obtain plain tablets; Coating: Put the plain tablets in a high-efficiency coating machine for film coating.

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Abstract

The invention relates to a trimetazidine hydrochloride sustained-release pharmaceutical composition and a preparation method thereof. The composition consists of an effective amount of trimetazidine hydrochloride and pharmaceutical auxiliary materials, the ratio of the main drug is 10%-20%, the slow-release material hypromellose is 10%-45%, and the slow-release material carbomer is 22%. ~40%, Sustained-release material Eudragit 0.2%~10%, diluent calcium hydrogen phosphate dihydrate 10%~48%, glidant colloidal silicon dioxide 0.3%~1.5%, magnesium stearate 0.5%~ 1.5%. The invention also provides a preparation method of the trimetazidine hydrochloride composition, that is, granulating through direct mixing process or fluidized bed, tableting and coating. The invention overcomes the defect of trimetazidine hydrochloride in the prior art that multiple administrations are required due to its short relative half-life, and can avoid side effects caused by excessive initial concentration of administration; the preparation process is simple and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to a trimetazidine hydrochloride sustained-release tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Trimetazidine hydrochloride (Trimetazidine dihydrochloride, TM) is an antianginal drug with clinical efficacy, which has been used for the prevention and treatment of angina pectoris; Long-acting nitrate), trimetazidine hydrochloride is an anti-ischemic drug that selectively inhibits 3-ketoacyl-CoA thiolase, reduces free fatty acid metabolism and increases glucose oxidation, thereby increasing myocardial energy supply , improve heart function, and has a certain degree of myocardial protection, clinically mainly used for the prevention and treatment of angina pectoris and the adjuvant treatment of string dizziness and tinnitus. [0003] The chemical name of trimetazidine hydrochloride is 1-[(2,3,4-trimethoxyphenyl)methyl]piperazine, the structural...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/20A61K47/38A61K47/32A61K31/495A61P9/10
CPCA61K9/28A61K9/2054A61K9/2027A61K9/2095A61K31/495A61P9/10
Inventor 邹永华李青青李颖陈晓萍彭展晶骆雨洁
Owner HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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