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

A technology of trimetazidine hydrochloride and sustained-release preparations, which is applied in the fields of anti-toxic agents, pill delivery, and pharmaceutical formulations, and can solve problems such as cumbersome operations, long time-consuming, and complicated processes

Active Publication Date: 2022-08-09
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The coating process of 3 kinds of pellets with different weight gain is complicated and difficult, and the coating weight gain in the middle cannot be controlled centrally. The uniformity of drug-containing and the sustained-release effect cannot be reproduced very well. If individual sustained-release coating films are ruptured, there will be sudden release of the drug.
The preparation process is cumbersome to operate and requires the use of freeze-drying equipment, which is time-consuming, high in cost, low in yield and difficult to control, and there is a risk of introducing new impurities during the preparation process

Method used

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

Examples

Experimental program
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Effect test

Embodiment 1

[0016] Prescription composition Prescription volume 1000 tablets / g Viblitizine hydrochloride 80 corn starch 20 Juweitone K30 5 Hydroxyl cellulose 39 Magnesium stearate 1

[0017] Preparation process: Add hydrochloride, polyhone K30, and corn starch to the wet -made particle cooker body, turn on the mixing knife and cut cutter for 10min pre -mixing. Wet wet -fired granules; after the purification water is sprayed into the pellets for 3 minutes; the obtained wet particles are wet, and then put in the fluidized bed for drying. The amount of mixed -release materials is mixed for 20 minutes, and then the prescribed amount of magnesium magnesium is added evenly for 5 minutes. Finally, the mixed material is transferred to the high -speed rotary compressor for pressure, which is the finished tablet.

Embodiment 2

[0019] Prescription composition Prescription volume 1000 tablets / g Viblitizine hydrochloride 80 corn starch 20 Juweitone K30 5 Polyette oxygenne 303 39 Magnesium stearate 1

[0020] Slow -release materials use polyethylene oxylene 303, and other prescription composition and preparation processes 1.

Embodiment 3

[0022] Prescription composition Prescription volume 1000 tablets / g Viblitizine hydrochloride 80 corn starch 20 Juweitone K30 5 Sodium alginate 39 Magnesium stearate 1

[0023] The mitigation material uses sodium algina, and other prescription composition and preparation process are the same as the embodiment 1.

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Abstract

The invention provides a trimetazidine hydrochloride sustained-release preparation and a preparation method thereof. The trimetazidine hydrochloride sustained-release preparation is composed of sustained-release microtablets and capsule shells, and each sustained-release capsule is composed of a Sustained release microtablets are filled. The microtablet is mainly composed of trimetazidine hydrochloride, a binder, a diluent, a sustained-release material and a lubricant. The trimetazidine hydrochloride sustained-release preparation comprises the following components in percentage by weight: trimetazidine hydrochloride 50-80%, diluent 1-20%, binder 1-20%, sustained-release material 10-40% %, lubricant 0.1 to 5%. The invention also discloses a preparation method of the trimetazidine hydrochloride sustained-release preparation: each material is granulated and then pressed into microtablets, and then filled into hollow capsules according to a certain amount. The preparation process has good stability, simple process and high production efficiency, and is suitable for industrialized mass production.

Description

Technical field [0001] The invention involves the field of drug preparations, and it specifically involves a chimirazine hydrochloride slow release preparation and its preparation methods. Background technique [0002] Trimetazidine dihydrochloride, which belongs to a derivative of azine, mainly protects the level of the ATP level in the ATP level by protecting the energy metabolism of cells under hypoxia or ischemia, thereby ensuring that the normal ion pump is normal The normal operation of the function and the sodium -permeable -potassium flow, maintain the stability of the intracellular environment. It is mainly used to treat coronary heart disease angina pectoris. After oral administration, Qu Meizine absorbs quickly, reaching the plasma peak concentration within 2 hours. After a single oral Qumeizine 20 mg, the plasma peak concentration is about 55ng / ml. After repeated administration, it reached a steady-state concentration 24-36 hours, and it remained very stable throughou...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K9/22A61K47/12A61K47/38A61K47/10A61K47/36A61K47/32A61K31/495A61P39/00
CPCA61K9/4808A61K9/2013A61K9/2054A61K9/2031A61K9/205A61K9/2027A61K31/495A61P39/00
Inventor 尹来生陈金脱朱春莉朱光瑜
Owner 南京康川济医药科技有限公司
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