High-stability sustained-release tablet prepared by using hydroxy propyl cellulose

A hydroxypropyl cellulose, using hydroxypropyl technology, applied in the field of sustained-release tablets, can solve the problems of increased hydrochloride, difficulty in ensuring that related substances meet quality standards, poor stability of sustained-release tablets, etc., to achieve the reduction of koji hydrochloride. Degradation of metazine, improvement of product stability, and convenient operation

Active Publication Date: 2012-12-19
ZHEJIANG CHENGYI PAHRMACEUTICAL +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After a lot of research, we found that the sustained-release tablet product has poor stability. Hydrochloride all rises rapidly, so it is difficult to ensure that its related substances meet the quality standards during storage

Method used

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  • High-stability sustained-release tablet prepared by using hydroxy propyl cellulose
  • High-stability sustained-release tablet prepared by using hydroxy propyl cellulose
  • High-stability sustained-release tablet prepared by using hydroxy propyl cellulose

Examples

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preparation example Construction

[0062] The preferred preparation method of the high-stability sustained-release tablet prepared by the present invention using hydroxypropyl cellulose comprises two kinds, and the first comprises the following steps:

[0063] (i) Mix 5-40 parts by weight of trimetazidine hydrochloride, 10-85 parts by weight of hydroxypropyl cellulose and a filler, add a binder, and make a soft material,

[0064] (ii) granulating, drying, sizing, drying and tableting the soft material to prepare trimetazidine hydrochloride sustained-release tablets.

[0065] Any method known in the field of formulation can be used to carry out the steps of mixing, preparing the soft material, granulating, drying, sizing, drying or tableting the soft material.

[0066] The second preparation method is to put all the raw and auxiliary materials in a container, mix them uniformly, and then perform tablet compression.

[0067] The main advantages of the present invention are:

[0068] 1. A steady-release trimetaz...

Embodiment 1

[0076] Preparation of Trimetazidine Hydrochloride Sustained Release Tablet 1

[0077] 1000 pieces

[0078]

[0079] Preparation:

[0080] Grind trimetazidine hydrochloride, hydroxypropyl cellulose (viscosity: 150-400 centipoise), and calcium hydrogen phosphate, pass through an 80-mesh sieve, and mix well. Add appropriate amount of water during stirring to granulate, dry and granulate. Then, add magnesium stearate and micropowder silica gel to the dry granules after granulation, put them in a mixer and mix them evenly. Tablet, get 1000 trimetazidine hydrochloride sustained-release tablets 1.

Embodiment 2

[0082] Preparation of Trimetazidine Hydrochloride Sustained Release Tablet 2

[0083] 1000 pieces

[0084]

[0085] Preparation:

[0086] Grind trimetazidine hydrochloride, hydroxypropyl cellulose (viscosity: 1000-4000 centipoise) and mannitol, pass through an 80-mesh sieve, and mix well. Add appropriate amount of water during stirring to granulate, dry and granulate. Add magnesium stearate to the above-mentioned dry granules after granulation, and put them in a mixer to mix evenly. Tablet, get 1000 trimetazidine hydrochloride sustained-release tablets 2.

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Abstract

The invention provides a high-stability sustained-release tablet prepared by using hydroxy propyl cellulose. The sustained-release tablet comprises the following components in parts by weight: 5-40 parts of trimetazidine hydrochloride and 10-85 parts of hydroxy propyl cellulose. A preparation method for the high-stability sustained-release tablet is a common wet granulation tableting process or a powder direct tableting process. According to the trimetazidine hydrochloride sustained-release tablet prepared by using the hydroxy propyl cellulose as a sustained-release material, the problem of low stability of a commercially available trimetazidine hydrochloride sustained-release tablet prepared by using the hydroxy propyl cellulose as a sustained-release material is solved.

Description

technical field [0001] The invention belongs to the field of sustained-release pharmaceutical preparations, in particular to a sustained-release tablet prepared by using hydroxypropyl cellulose as a sustained-release material, which has significantly improved stability. Background technique [0002] Trimetazidine hydrochloride is an anti-angina cardiovascular drug. By protecting the energy metabolism of cells under hypoxic or ischemic conditions, it prevents the decline of intracellular ATP levels, thereby ensuring the normal function of the ion pump and the transmembrane sodium-potassium flow. normal operation and maintain the stability of the intracellular environment. Trimetazidine hydrochloride is clinically used for preventive treatment of angina pectoris attack, auxiliary symptomatic treatment of vertigo and tinnitus, etc. [0003] Clinical oral trimetazidine hydrochloride common tablet needs to take medicine three times a day, and this brings inconvenience to patient...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K9/22A61K31/495A61P9/10A61P1/08A61P27/16
Inventor 颜贻意周小梅郝天云张建军高缘
Owner ZHEJIANG CHENGYI PAHRMACEUTICAL
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