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Quetiapine fumarate sustained-release capsule and preparation method thereof

A technology for quetiapine fumarate and quinoline fumarate, which is applied in the field of pharmaceutical preparations and can solve the problems of complex process, many preparation steps and the like

Inactive Publication Date: 2015-04-29
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are few invention patents about quetiapine fumarate sustained-release capsules. CN103211794A discloses quetiapine fumarate film-controlled sustained-release pellet capsules. The sustained-release coating includes Eudragit RL30D, plasticizer citric acid Composed of triethyl ester and anti-sticking agent talcum powder, but its preparation steps are many and the process is complicated

Method used

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  • Quetiapine fumarate sustained-release capsule and preparation method thereof
  • Quetiapine fumarate sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 Preparation of quetiapine fumarate sustained-release capsules (calculated as quetiapine, 50 mg)

[0019] Bead composition Dosage g Quetiapine Fumarate 58 Ethyl cellulose 20 Hypromellose 20 microcrystalline cellulose 110 Povidone K30 37 talcum powder 5 total 250

[0020] Preparation Process:

[0021] (1) Take the prescribed amount of quetiapine fumarate, ethyl cellulose, microcrystalline cellulose, povidone K30, and talcum powder, mix well, pass through an 80-mesh sieve and mix well;

[0022] (2) Prepare 3% hydroxypropyl methylcellulose aqueous solution as binder;

[0023] (3) Add appropriate amount of (2) to (1) to prepare soft material;

[0024] (4) Put the above-mentioned soft material into the extrusion spheronizer, extrude in a strip state, the extrusion mesh is 20 mesh, put the extruded strip in the centrifugal spheronizer, adjust the suitable speed of 200rpm-600rpm, and spheronize;

[0025] (5) ...

Embodiment 2

[0027] Example 2 Preparation of quetiapine fumarate sustained-release capsules (calculated as quetiapine, 200 mg)

[0028] Bead composition Dosage g Quetiapine Fumarate 230 Ethyl cellulose 50 Hypromellose 16.5 microcrystalline cellulose 53.5 Povidone K30 6 talcum powder 24 total 380

[0029] Preparation Process:

[0030] (1) Take the prescribed amount of quetiapine fumarate, ethyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, and talcum powder, mix them evenly, and pass through an 80-mesh sieve to mix evenly;

[0031] (2) prepare 3% povidone K30 aqueous solution as adhesive;

[0032] (3) Add appropriate amount of (2) to (1) to prepare soft material;

[0033] (4) Put the above-mentioned soft material into the extrusion spheronizer, extrude in a strip state, the extrusion mesh is 20 mesh, put the extruded strip in the centrifugal spheronizer, adjust the suitable speed of 200rpm-600rpm, and sphero...

Embodiment 3

[0036] Example 3 Preparation of quetiapine fumarate sustained-release capsules (calculated as quetiapine, 300 mg)

[0037] Bead composition Dosage g Quetiapine Fumarate 345 Ethyl cellulose 86.25 Hypromellose 86.25 microcrystalline cellulose 103.5 Povidone K30 2.1 silica 6.9 total 630

[0038] (1) Take the prescribed amount of quetiapine fumarate, ethyl cellulose, microcrystalline cellulose, povidone K30, and talcum powder, mix well, pass through an 80-mesh sieve and mix well;

[0039] (2) Prepare 3% hydroxypropyl methylcellulose aqueous solution as binder;

[0040] (3) Add appropriate amount of (2) to (1) to prepare soft material;

[0041] (4) Put the above-mentioned soft material into the extrusion spheronizer, extrude in a strip state, the extrusion mesh is 20 mesh, put the extruded strip in the centrifugal spheronizer, adjust the suitable speed of 200rpm-600rpm, and spheronize;

[0042] (5) Dry in a fluidized bed un...

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Abstract

The invention discloses a matrix type sustained-release pellet capsule rich in quetiapine fumarate. The matrix type sustained-release pellet capsule has the characteristics of sustained release, long administration interval, low toxic and side effects and the like, and is used for treating schizophrenia. The invention also provides a preparation method and belongs to the technical field of medical science and pharmacy.

Description

technical field [0001] The invention relates to a quetiapine fumarate sustained-release capsule, in particular to a quetiapine fumarate skeleton-type sustained-release pellet capsule and a preparation method thereof, belonging to the field of pharmaceutical preparations. The quetiapine fumarate sustained-release capsule can be used for treating schizophrenia. Background technique [0002] Quetiapine fumarate is an atypical anti-schizophrenia drug. It is a diphenoxazepine drug and belongs to a multi-receptor drug. It has a high affinity for serotonin receptors in the brain and has a Dopamine D1 and D2 receptors have a strong affinity. [0003] At present, quetiapine fumarate ordinary tablet specifications are 25mg, 100mg, 200mg and 300mg. The domestic conventional oral dose is 25mg each time, twice a day, increasing by 25mg every 1-3 days, and gradually increasing to a total therapeutic dose of 300 mg. -600mg. Quetiapine is rapidly absorbed after oral administration, reach...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/554A61P25/18A61K47/38
Inventor 黄慧玲刁媛媛马苏峰
Owner AVENTIS PHARMA HAINAN
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