Mirtazapine tablet and preparation method thereof

A kind of mirtazapine tablet, the technology of mirtazapine, applied in the field of mirtazapine tablet and its preparation, can solve the problems such as the reduction of mirtazapine clearance rate, achieve the effect of low production cost, simple preparation and operation, and stable quality

Active Publication Date: 2014-01-22
SHANDONG LUYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Impaired liver and kidney function can

Method used

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  • Mirtazapine tablet and preparation method thereof
  • Mirtazapine tablet and preparation method thereof
  • Mirtazapine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Mirtazapine 30g

[0034] Lactose 40g

[0035] Starch 200g

[0036] 10% hydroxypropyl cellulose aqueous solution 200ml

[0037] Magnesium stearate 0.75g

[0038] Micronized silica gel 0.75g

[0039] Preparation method: pass lactose and starch through an 80-mesh sieve; micronized mirtazapine (determination of particle size: Dav=16.552, D 10 =6.720μm, D 50 =15.221μm, D 90 =33.190μm) mixed with lactose and starch according to equal increment method; add 10% hydroxypropyl cellulose aqueous solution to make soft material; granulate with 24 mesh sieve; 3 times; 20-mesh sieve for granulation; add prescription amount of magnesium stearate and micropowder silica gel to the granules after granulation, mix evenly, and compress into tablets. The formulation was coated with gastric-soluble Opadry using conventional coating equipment.

Embodiment 2

[0041] Mirtazapine 30g

[0042] Lactose 180g

[0043] Starch 70g

[0044] 10% hydroxypropyl cellulose aqueous solution 120ml

[0045] Magnesium Stearate 1.5g

[0046] Micronized silica gel 0.75g

[0047] Preparation method: pass lactose and starch through an 80-mesh sieve; micronized mirtazapine (determination of particle size: Dav=18.453, D 10 =7.291μm, D 50 =17.195μm, D 90=35.184μm) mixed with lactose and starch according to equal increment method; add 10% hydroxypropyl cellulose aqueous solution to make soft material; granulate with 24 mesh sieve; 3 times; 20-mesh sieve for granulation; add prescription amount of magnesium stearate and micropowder silica gel to the granules after granulation, mix evenly, and compress into tablets. The formulation was coated with gastric-soluble Opadry using conventional coating equipment.

Embodiment 3

[0049] Mirtazapine 30g

[0050] Lactose 160g

[0051] Starch 100g

[0052] 8% hydroxypropyl cellulose aqueous solution 100ml

[0053] Magnesium stearate 1.2g

[0054] Micronized silica gel 1.2g

[0055] Preparation method: pass lactose and starch through an 80-mesh sieve; micronized mirtazapine (determination of particle size: Dav=19.142, D 10 =6.560μm, D 50 =18.814μm, D 90 =37.510μm) mixed with lactose and starch according to equal increment method; add 10% hydroxypropyl cellulose aqueous solution to make soft material; granulate with 24 mesh sieve; 3 times; 20-mesh sieve for granulation; add prescription amount of magnesium stearate and micropowder silica gel to the granules after granulation, mix evenly, and compress into tablets. The formulation was coated with gastric-soluble Opadry using conventional coating equipment.

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Abstract

The invention relates to a mirtazapine tablet and a preparation method thereof. The mirtazapine tablet is prepared from a tablet core and a coating layer, wherein the tablet core contains 15-45mg of mirtazapine, 40-180mg of lactose, 70-200mg of starch, 8-25mg of hydroxy propyl cellulose, 0.75-3mg of magnesium stearate and 0.75-3mg of aerosol. The particle size range of the mirtazapine is 3.0-96.0 microns; the coating layer accounts for 2.0-3.0% of weight of the tablet core. The obtained mirtazapine tablet preparation disclosed by the invention is stable in quality, simple to prepare and operate, low in production cost, and applicable to industrial mass production. The mirtazapine tablet prepared by the invention simulates operation of the tablets in the stomach and intestines; an in vitro dissolution curve is determined; the mirtazapine tablet is good in consistency between batches, stable and controllable in quality, and consistent with the dissolution behaviors of an original development agent in four different mediums.

Description

Technical field [0001] The invention is the field of drug preparations. More specifically, the present invention involves a rice nitrogen tablets and its preparation methods. Background technique [0002] Mirtazapine is a well-known drug for treating depression. It has a four-ring structure and belongs to a thiazide-nitrogen-juice compound.As a antidepressant, rice nitrogen is self -contained.Mitian is a central acoustic advanced membrane α2 receptor antagonist, which can enhance the nerve conduction of adrenaline.At the same time, it blocks the 5-HT2 and 5-HT3 receptors of the center. Two glory of Mitang has antidepressant activity.-HT3 receptor.The characteristic (H1) characteristics of Mi nitrogen play a sedative effect.The medicine has a good tolerance, almost impact on the effect of anti -choline, and has no effect on the cardiovascular system.Mitang is suitable for depression, lack of pleasure such as symptoms, mental motor suppression, poor sleep, and weight loss.It can al...

Claims

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Application Information

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IPC IPC(8): A61K31/55A61K9/36A61K9/30A61P25/24
Inventor 彭燕凤许卫东
Owner SHANDONG LUYAO PHARMA
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