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 low yield, uneasy control, and increased failure rate of pellets

Active Publication Date: 2021-02-05
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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  • Trimetazidine hydrochloride sustained-release preparation and preparation method thereof
  • Trimetazidine hydrochloride sustained-release preparation and preparation method thereof
  • Trimetazidine hydrochloride sustained-release preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0016] prescription composition Prescription quantity 1000 tablets / g trimetazidine hydrochloride 80 corn starch 20 Povidone K30 5 Hydroxypropyl Cellulose 39 Magnesium stearate 1

[0017] Preparation process: Add trimetazidine hydrochloride, povidone K30, and corn starch into the pot of the wet granulator, turn on the stirring knife and cutting knife for 10 minutes of premixing, after the mixing is completed, turn on the stirring knife and cutting knife and spray into purified water Carry out wet granulation; continue to granulate for 3 minutes after the purified water is sprayed; wet granules are wet granulated, and then put into a fluidized bed for drying, and the dried granules are dry granulated; the dry granules are mixed with the prescription A certain amount of sustained-release material was mixed for 20 minutes, then the prescribed amount of magnesium stearate was added evenly for 5 minutes, and finally the mixed material was...

Embodiment 2

[0019] prescription composition Prescription quantity 1000 tablets / g trimetazidine hydrochloride 80 corn starch 20 Povidone K30 5 Polyethylene oxide 303 39 Magnesium stearate 1

[0020] The sustained-release material is polyethylene oxide 303, and the composition and preparation process of other prescriptions are the same as in Example 1.

Embodiment 3

[0022] prescription composition Prescription quantity 1000 tablets / g trimetazidine hydrochloride 80 corn starch 20 Povidone K30 5 sodium alginate 39 Magnesium stearate 1

[0023] Sodium alginate is used as the slow-release material, and the composition and preparation process of other prescriptions are the same as those in Example 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 micro-tablets and capsule shells, and each sustained-release capsule is formed by filling the sustained-release micro-tablets with the diameter of 1-3mm. The trimetazidine hydrochloride micro-tablet is mainly composed of trimetazidine hydrochloride, an adhesive, a diluent, a sustained-release material and a lubricant. The trimetazidine hydrochloride sustained-release preparation comprises the following components in percentage by weight of 50 to 80 percent of trimetazidine hydrochloride, 1 to 20 percent of diluent, 1 to 20 percent of adhesive, 10 to 40 percent of sustained-releasematerial and 0.1 to 5 percent of lubricant. The invention also discloses a preparation method of the trimetazidine hydrochloride sustained-release preparation, which comprises the following steps of granulating the materials, tabletting, and filling into hollow capsules according to a certain quantity. The preparation process is good in stability, simple in process, high in production efficiency and suitable for industrial mass production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a trimetazidine hydrochloride sustained-release preparation and a preparation method thereof. Background technique [0002] Trimetazidine Dihydrochloride, a derivative of piperazines, mainly prevents the decline of intracellular ATP levels by protecting the energy metabolism of cells under hypoxic or ischemic conditions, thus ensuring the normal operation of ion pumps function and the normal operation of transmembrane sodium-potassium flow, and maintain the stability of the intracellular environment. It is mainly used clinically to treat angina pectoris of coronary heart disease. After oral administration, trimetazidine is rapidly absorbed and peak plasma concentrations are reached within 2 hours. After a single oral dose of trimetazidine 20 mg, the peak plasma concentration is approximately 55 ng / ml. After repeated dosing, steady-state concentrations are reached wit...

Claims

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Application Information

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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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