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Trimetazidine hydrochloride tablet and preparation method thereof

A technology of trimetazidine hydrochloride and trimetazidine hydrochloride, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of unknown absorption, distribution and excretion, and the inability to predict the clinical therapeutic effect and other issues, to achieve the effects of reducing production costs, being suitable for large-scale production, and being easy to prepare

Active Publication Date: 2018-05-04
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Therefore, the technical problem to be solved in the present invention is to overcome the quality standard that trimetazidine hydrochloride tablet can only reach tablet in the prior art, and the absorption in vivo, distribution and excretion are unknown, can't infer the defective of its clinical treatment effect, Thereby providing a kind of trimetazidine hydrochloride tablet whose quality meets the standard and can be well absorbed, distributed and metabolized in the body, thus has good clinical therapeutic effect and safety, and further provides its preparation method

Method used

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  • Trimetazidine hydrochloride tablet and preparation method thereof
  • Trimetazidine hydrochloride tablet and preparation method thereof
  • Trimetazidine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The trimetazidine hydrochloride coated tablet of the present embodiment, prescription is:

[0038]

[0039] Preparation Process:

[0040]Trimetazidine hydrochloride is passed through a 60 mesh sieve, and mannitol is passed through a 50 mesh sieve to prepare trimetazidine hydrochloride after sieving and mannitol after sieving, and take trimetazidine hydrochloride 20Kg after sieving, Cornstarch 28kg, 4.5Kg povidone K120 and 35.15kg mannitol after sieving to obtain mixed material A, mixed material A is added in the hopper of the wet mixing granulator, the pot cover is opened, the stirring I speed button is opened, and mixed for 180s Finally, turn on the II speed button, mix for 180s, and mix evenly to obtain the mixed material B, then turn on the I speed of stirring, chop the II speed, open the feeding slurry valve on the wet mixing granulator, and wet mixing at the speed of the peristaltic pump at 60rpm Under the condition that the atomization pressure of the granulat...

Embodiment 2

[0044] The trimetazidine hydrochloride coated tablet of the present embodiment, prescription is:

[0045]

[0046] The preparation process is:

[0047] Trimetazidine hydrochloride is passed through a 60-mesh sieve, and mannitol is passed through a 50-mesh sieve to prepare trimetazidine hydrochloride after sieving and mannitol after sieving, and take trimetazidine hydrochloride 18Kg after sieving, Cornstarch 25kg, 5Kg povidone K120 and 37kg of mannitol after sieving obtain mixed material A, mixed material A is added in the hopper of wet mixing granulator, open pot cover, open stirring I speed button, after mixing 180s, Turn on the speed II button, mix for 180s, and mix evenly to obtain the mixed material B, then turn on the stirring speed I, chop the speed II, open the feeding slurry valve on the wet mixing granulator, the speed of the peristaltic pump is 60rpm, and the atomization pressure is 0.3 Under the condition of Mpa, 8Kg of purified water is added, and the control t...

Embodiment 3

[0051] The trimetazidine hydrochloride coated tablet of the present embodiment, prescription is:

[0052]

[0053]

[0054] Preparation Process:

[0055] Trimetazidine hydrochloride is passed through a 60 mesh sieve, and mannitol is passed through a 50 mesh sieve to prepare trimetazidine hydrochloride after sieving and mannitol after sieving, and take trimetazidine hydrochloride 22Kg after sieving, Cornstarch 30kg, 4.0Kg povidone K120 and 33kg of mannitol after sieving to obtain mixed material A, mixed material A is added in the hopper of the wet mixing granulator, the pot cover is opened, the stirring I speed button is turned on, and after mixing for 180s , turn on the button of speed II, mix for 180s, mix evenly to obtain the mixed material B, then turn on the speed of stirring I, chop the speed II, open the feeding slurry valve on the wet mixing granulator, and the speed of the peristaltic pump is 60rpm, wet mixing granules Under the condition of machine atomization ...

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Abstract

The invention belongs to the field of medicine preparations, and particularly relates to a trimetazidine hydrochloride tablet and a preparation method thereof. The trimetazidine hydrochloride tablet is prepared from the following raw materials in parts by weight: 18 to 22 parts of trimetazidine hydrochloride, 58 to 67 parts of filling agent, 4 to 5 parts of adhesive, 1.7 to 2.7 parts of lubricant,and 8 to 13 parts of wetting agent. The preparation method comprises the following steps of screening the trimetazidine hydrochloride and the filling agent, so as to obtain the screened trimetazidinehydrochloride and the screened filling agent; respectively selecting the screened trimetazidine hydrochloride, the screened filling agent and the adhesive, and uniformly mixing in a wet way, so as toobtain a mixture B; adding the wetting agent into the mixture B, granulating, drying, and arranging, so as to obtain a granule; adding the lubricant into the granule, mixing, and tabletting, so as toobtain the trimetazidine hydrochloride tablet. The trimetazidine hydrochloride tablet has the advantages that the quality meets the standard; the trimetazidine hydrochloride tablet can be well absorbed, distributed and metabolized in a human body; the good clinical treatment effect and safety are realized.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a trimetazidine hydrochloride tablet and a preparation method thereof. Background technique [0002] Angina pectoris is a clinical syndrome characterized by paroxysmal chest pain or chest discomfort caused by coronary artery insufficiency and acute temporary ischemia and hypoxia of the myocardium. It is the pain felt when the heart ischemia is reflected to the surface of the body. The mechanism of pain during myocardial ischemia is that some products in the anaerobic metabolism of the myocardium stimulate the afferent nerve endings in the heart. Existing antianginal drugs include nitrates, adrenoceptor antagonists, calcium channel blockers and other antianginal drugs. [0003] Trimetazidine hydrochloride, also known as trimetazine, is another class of anti-anginal drugs. It can more effectively control the energy supply balance of free fatty acid / glucose ox...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/32A61K47/04A61P9/10
CPCA61K9/2009A61K9/2027A61K31/495
Inventor 王丹梅王淑啸邓银来宋利来张永娥袁卫东臧建英黄春荣
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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