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Mirtazapine tablet and preparation method thereof

A technology of mirtazapine tablets and tablet cores, which is applied in the field of mirtazapine tablets and its preparation, can solve the problems of poor release uniformity and slow dissolution rate, achieve low production cost, stable quality, and reduce the occurrence of adverse reactions rate effect

Inactive Publication Date: 2017-07-14
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing mirtazapine preparations still have problems such as poor release uniformity and slow dissolution rate.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A mirtazapine tablet is composed of a tablet core and a coating layer, calculated in parts by weight, the tablet core comprises the following raw and auxiliary materials: 30 parts of mirtazapine, 200 parts of lactose, 60 parts of sodium carboxymethyl starch, microcrystalline 40 parts of cellulose, 20 parts of low-substituted hydroxypropyl cellulose, 2 parts of magnesium stearate and 2 parts of micropowder silica gel; the coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol. The coating layer was 2% by weight of the tablet core.

[0022] The preparation method includes the following steps:

[0023] 1) sieve mirtazapine, magnesium stearate, sodium carboxymethyl starch, micropowder silica gel, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose for subsequent use;

[0024] 2) Take mirtazapine, sodium carboxymethyl starch, lactose, purified water, and add them to a wet granulator for granulation, and place th...

Embodiment 2

[0028] A mirtazapine tablet is composed of a tablet core and a coating layer, calculated in parts by weight, the tablet core includes the following raw and auxiliary materials: 20 parts of mirtazapine, 120 parts of lactose, 80 parts of sodium carboxymethyl starch, microcrystalline 30 parts of cellulose, 150 parts of low-substituted hydroxypropyl cellulose, 1 part of magnesium stearate and 1 part of micropowder silica gel; the coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol. The coating layer was 1.8% by weight of the tablet core.

[0029] The preparation method includes the following steps:

[0030] 1) sieve mirtazapine, magnesium stearate, sodium carboxymethyl starch, micropowder silica gel, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose for subsequent use;

[0031] 2) Take mirtazapine, sodium carboxymethyl starch, lactose, purified water, and add them to a wet granulator for granulation, and place th...

Embodiment 3

[0035] A mirtazapine tablet is composed of a tablet core and a coating layer, calculated in parts by weight, the tablet core includes the following raw and auxiliary materials: 45 parts of mirtazapine, 240 parts of lactose, 40 parts of sodium carboxymethyl starch, microcrystalline 60 parts of cellulose, 30 parts of low-substituted hydroxypropyl cellulose, 3 parts of magnesium stearate and 3 parts of micropowder silica gel; the coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol. The coating layer was 2.4% by weight of the tablet core.

[0036] The preparation method includes the following steps:

[0037] 1) sieve mirtazapine, magnesium stearate, sodium carboxymethyl starch, micropowder silica gel, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose for subsequent use;

[0038] 2) Take mirtazapine, sodium carboxymethyl starch, lactose, purified water, and add them to a wet granulator for granulation, and place t...

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PUM

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Abstract

The invention provides a mirtazapine tablet and a preparation method thereof. The mirtazapine tablet comprises a core and a coating layer. The core comprises 20 to 45 parts of mirtazapine, 120 to 240 parts of lactose, 40 to 80 parts of sodium carboxymethyl starch, 30 to 60 parts of microcrystalline cellulose, 15 to 30 parts of low-substituted hydroxypropylcellulose, 1 to 3 parts of magnesium stearate and 1 to 3 parts of fine powder silica gel. The coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol. The preparation method comprises 1) sieving the raw and auxiliary materials of the tablet core, 2) carrying out wet granulation on the core raw materials to obtain the core, and 3) coating the tablet core to obtain the mirtazapine tablet. The dissolution of the tablet has particle size dependence, the drug release rate is stable, and side effects caused by fluctuation of the drug release rate can be avoided.

Description

technical field [0001] The invention belongs to the technical field of antidepressant pharmaceutical preparations, in particular to a mirtazapine tablet and a preparation method thereof. Background technique [0002] Mirtazapine is a well-known drug for the treatment of depression, has a tetracyclic structure, and belongs to the piperazine-azepine class of compounds. As an antidepressant, mirtazapine is in a class of its own. Mirtazapine is a central presynaptic α2 receptor antagonist that enhances adrenergic nerve conduction. It blocks both central 5-HT2 and 5-HT3 receptors at the same time. Both optical enantiomers of mirtazapine have antidepressant activity. -HT3 receptors. The antihistamine receptor (H1) properties of mirtazapine act as a sedative. The drug is well tolerated, has almost no anticholinergic effects, and has no effect on the cardiovascular system. Mirtazapine is indicated for depression and is effective for symptoms such as anhedonia, psychomotor depre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K9/28A61K47/10A61K47/02A61K47/36A61K47/04A61K47/38A61K31/55A61P25/24
CPCA61K9/2853A61K9/2009A61K9/2054A61K9/2059A61K9/2813A61K31/55
Inventor 高煜操铖
Owner HUAYI PHARMA ANHUI CO LTD
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