Amisulpride tablet and preparation method thereof

A technology of amisulpride tablets and amisulpride, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, pill delivery, etc., can solve problems such as sticking and punching, and achieve solving the problem of sticking and punching, reducing drying process, Avoid the effect of sticking

Inactive Publication Date: 2020-10-02
YANGTAI PHARMA SHANDONG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the technical problems existing at present, the present invention provides a kind of amisulpride tablet and its preparation method. The preparation method solves the problem of sticking and punching when tableting, and prepares a kind of amisulpride that is pharmaceutically equivalent to the original drug in vitro. slices

Method used

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  • Amisulpride tablet and preparation method thereof
  • Amisulpride tablet and preparation method thereof
  • Amisulpride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A kind of amisulpride tablet:

[0028] 1. Prescription

[0029] prescription Dosagekg Amisulpride 20 lactose 13.92 microcrystalline cellulose 5.76 Carboxymethyl Starch Sodium 5.28 hypromellose 0.88 Magnesium stearate 0.72 stearic acid 1.44

[0030] 2. Process (preparation of 100,000 pieces)

[0031] 1. Granulation

[0032] Pour lactose, amisulpride, microcrystalline cellulose, carboxymethyl starch sodium, hypromellose and stearic acid into the wet mixing granulator in turn, set the stirring speed at 150rpm, the cutter speed at 2000rpm, pre- Mix for 6 minutes. After the premixing is completed, open the pot cover and clean the powder on the pot body into the pot body. After the interlayer of the wet mixing granulator is heated to 90 degrees, continue to run for 15 minutes, cool the interlayer to room temperature, continue to run for 10 minutes, and discharge Get granules.

[0033] 2. Whole grain mixing

[0034...

Embodiment 2

[0039] A kind of amisulpride tablet:

[0040] 1. Prescription

[0041]

[0042]

[0043] 2. Process (preparation of 100,000 pieces)

[0044] Pour lactose, amisulpride, microcrystalline cellulose, carboxymethyl starch sodium, hypromellose and polyethylene glycol 6000 into the wet mixing granulator in turn, set the stirring speed to 300rpm, and the cutter speed to 1500rpm , pre-mixed for 6 minutes, after the pre-mixing is completed, open the lid to clean the powder on the pot body into the pot, after the interlayer of the wet mixing granulator is heated to 90 degrees, continue to run for 15 minutes; the interlayer is cooled to room temperature, continue to run for 10 minutes, and then Feed particles.

[0045] 2. Whole grain mixing

[0046] The granules are dry sized using a mobile granulator, installed with a mesh plate with a pore size of 2.0mm, and set the speed at 750rpm. The granulated granules are mixed with the magnesium stearate in a mixer.

[0047] 3. Tablet ...

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Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to an amisulpride tablet and a preparation method thereof. The amisulpride tablet comprises the followingingredients: amisulpride, adhesives, filling agents, disintegrating agents, lubricating agents and auxiliary lubricating agents. According to the amisulpride tablet prepared by the invention, the problem that the amisulpride tablet is likely to be subjected to sticking is solved, in addition, the amisulpride tablet has a good similarity with the dissolution curve of an original drug, has a good product appearance, has good stability and preparation technology tolerance and is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, in particular to an amisulpride tablet and a preparation method thereof. Background technique [0002] Amisulpride is white or off-white crystalline powder with a melting point of 124-128°C. This product is easily soluble in dichloromethane, slightly soluble in absolute ethanol, and almost insoluble in water. Chemical name 4-amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-ethanesulfonyl-2-methoxybenzamide, chemical structural formula: [0003] [0004] Amisulpride is an atypical antipsychotic drug used for the treatment of paranoid progressive schizophrenia, acute delirium psychosis, and also for the treatment of schizophrenia. [0005] At present, in the process of preparing amisulpride tablets, the phenomenon of sticking and punching is prone to occur during the tableting process. Coating of the head mold, changing the addition method of magnesium stearate, and sticking problems st...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/40A61K47/10A61K47/12A61K47/14A61K47/44A61K47/06A61P25/18
CPCA61K9/2013A61K9/2031A61K9/2095A61K31/40A61P25/18
Inventor 王玉广杨娟张汝德李洋
Owner YANGTAI PHARMA SHANDONG
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