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Trimebutine or its salt sustained release capsules and preparation method thereof

A technology for sustained-release capsules and pill cores, applied in the field of trimebutine or its salt sustained-release capsules and its preparation, capable of solving problems such as no sustained-release preparations on the market

Inactive Publication Date: 2009-02-11
亚宝药业太原制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Trimebutine tablets and capsules are already on the market in China, and some new dosage forms such as dispersible tablets and dry suspensions are applying for domestic registration and new drug clinical research. So far, no sustained-release preparations have been listed in China.

Method used

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  • Trimebutine or its salt sustained release capsules and preparation method thereof
  • Trimebutine or its salt sustained release capsules and preparation method thereof
  • Trimebutine or its salt sustained release capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0101] Embodiment 1: the preparation of trimebutine maleate sustained-release capsules

[0102] Trimebutine Maleate 150g

[0103] Ball core 60g

[0104] Microcrystalline Cellulose 150g

[0105] Hypromellose 8g

[0106] Acrylic resin RS30D:RL30D=10:1 180g

[0107] (Equivalent to 54g of acrylic polymer without solvent)

[0108] Triethyl citrate 6g

[0109] Talc powder 15g

[0110] 200ml of water;

[0111] The preparation method of the ball core is as follows: take microcrystalline cellulose fine powder in the centrifugal chamber and the powder supply chamber of the centrifugal granulator, use 3% hydroxypropyl methylcellulose as the binder, and the speed of the main machine is 150r / min~ 180r / min, blast flow rate 8L / min~10L / min, jet pressure 0.6Mpa~0.8MPa, jet flow rate 8L / min~10L / min, large flow spraying in the first 2 minutes, spray pump rotation speed is 70r / min min to 90r / min, then adjust to a medium-speed spraying flow rate, adjust the spray pump rotation speed to 30r...

Embodiment 2

[0113] Embodiment 2: the preparation of trimebutine maleate sustained-release capsules

[0114] Trimebutine Maleate 180g

[0115] Ball core 70g

[0116] Dextrin 110g

[0117] Carboxymethylcellulose 6g

[0118] Acrylic RS30D 36g

[0119] (Equivalent to 10.8g of acrylic acid polymer except the solvent)

[0120] Polyethylene glycol 6000 4.3g

[0121] Talc powder 6g

[0122] 50ml of water;

[0123] Wherein the preparation method of the ball core is: take the dextrin in the centrifugal chamber and the powder supply chamber of the centrifugal granulator, use 2% sodium carboxymethyl cellulose aqueous solution as the binder, and the speed of the main machine is 150r / min~180r / min, Blast flow rate is 8L / min~10L / min, jet pressure is 0.6Mpa~0.8MPa, jet flow rate is 8L / min~10L / min, the first 2 minutes is large flow spraying, and the rotation speed of spraying pump is 70r / min~90r / min, then adjust to medium-speed spraying flow rate, adjust the spray pump rotation number to 30r / min-5...

Embodiment 3

[0125] Embodiment 3: the preparation of trimebutine maleate sustained-release capsules

[0126] Trimebutine Maleate 130g

[0127] Ball core 90g

[0128] Lactose 140g

[0129] Povidone 6g

[0130] Acrylic resin RS100:RL100=9:1 36g

[0131] Triethyl citrate 3.6g

[0132] Talc powder 9g

[0133] 95% ethanol 300ml;

[0134]The preparation method of the ball core is as follows: take the lactose fine powder in the centrifugal chamber and the powder supply chamber of the centrifugal granulator, use 2% povidone aqueous solution as the binder, the speed of the main machine is 150r / min~180r / min, and the air blast The flow rate is 8L / min~10L / min, the jet pressure is 0.6Mpa~0.8MPa, the jet flow rate is 8L / min~10L / min, the first 2 minutes are large flow spraying, and the rotation speed of the spraying pump is 70r / min~90r / min. Then adjust the spray flow rate to medium speed, adjust the spray pump rotation speed to 30r / min-50r / min, continue to operate for 4 minutes, and then gradually...

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Abstract

The invention discloses a slow release capsule of trimebutine or the salt thereof and a preparation method thereof. The slow release capsule of trimebutine or the salt thereof is prepared by adding the accessories of filler, adhesive and slow release materials and the like into the trimebutine, wherein, the trimebutine can be replaced by the maleate thereof or other medicinal salts. The slow release capsule of trimebutine or the salt thereof can be obtained through the following preparation processes: a pill core is first prepared by adopting microcrystalline cellulose or starch and the like through centrifugation, spray cementing, powder supply, polishing and other processes and coated with a medicated layer to prepare a medicated pill core, which is then coated with a slow release film to make a trimebutine slow release mini-pill, finally the slow release capsule of trimebutine or the salt thereof is obtained after filling the mini-pill in a capsule. Compared with the common preparation, the slow release capsule can continue with drug delivery for up to 12 hours, and has comparably stable blood concentration and long time to peak. And the preparation method of the capsule is characterized by good repeatability and easy operation and the like.

Description

field of invention [0001] The invention relates to a preparation of trimebutine or a salt thereof and a preparation method thereof, in particular to a trimebutine or a salt thereof sustained-release capsule and a preparation method thereof. technical background [0002] Trimebutine, commonly used its maleate, (English name: trimebutine maleate, abbreviation: TMB), structural formula is as follows: [0003] [0004] It is a gastrointestinal rhythm agent different from cholinergic drugs and anti-dopamine drugs. It is mainly used clinically to treat gastrointestinal symptoms (abdominal distension, abdominal pain, nausea, belching) and irritable bowel syndrome caused by chronic gastritis. disease. [0005] The relevant characteristics of trimebutine are as follows: [0006] 1. Unlike cholinergic drugs and anti-dopamine drugs, which are gastrointestinal motility regulators, trimebutine can promote and inhibit bidirectional regulation of gastrointestinal motility due to diffe...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/24A61P1/04
Inventor 张淑秋王锐利王帅任武贤杨爱萍李成冯伟
Owner 亚宝药业太原制药有限公司
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