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Oral solid preparation taking prucalopride succinate as active ingredient and application of oral solid preparation

A technology of prucalopride succinate and solid preparation, which is applied in the field of medicine and can solve the problem of no 5-HT2 or 5-HT3 receptor antagonistic properties and the like

Inactive Publication Date: 2013-05-01
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The compounds also have no 5-HT2 or 5-HT3 receptor antagonistic properties

Method used

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  • Oral solid preparation taking prucalopride succinate as active ingredient and application of oral solid preparation
  • Oral solid preparation taking prucalopride succinate as active ingredient and application of oral solid preparation
  • Oral solid preparation taking prucalopride succinate as active ingredient and application of oral solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Make 1000 prucalopride succinate tablets with the raw materials of following weight ratio.

[0017]

[0018]

[0019] Preparation Process:

[0020] 1. The prucalopride succinate raw material is crushed through an 80-mesh sieve and set aside.

[0021] 2. Pass the lactose through a 60-mesh sieve and set aside.

[0022] 3. Take prucalopride succinate and mix well with microcrystalline cellulose, lactose and croscarmellose sodium.

[0023] 4. Make soft material with water, granulate with 20 mesh sieve, dry at 60°C, and granulate with 24 mesh sieve.

[0024] 5. Add magnesium stearate, mix well, and press into tablets.

Embodiment 2

[0026] 1. Prepare 6% ethanol solution of Opadry enteric coating agent;

[0027] 2. Take the plain tablet obtained in Example 1, pour it into the coating pan, start the coating pan, and blow hot air, preheat the plain tablet at 30-40°C for 10 minutes, and blow off the drug powder adhering to the tablet core, Spray the coating solution evenly, so that the drug solution is evenly coated on the tablet core, and then prucalopride succinate enteric-coated tablets are obtained.

Embodiment 3

[0029] Make 1000 prucalopride succinate tablets with the raw materials of following weight ratio.

[0030]

[0031] Preparation:

[0032] 1. Pulverize the prucalopride succinate bulk drug through an 80-mesh sieve and set aside.

[0033] 2. Fully mix prucalopride succinate with sorbitol, microcrystalline cellulose, croscarmellose sodium, and hypromellose E3 evenly.

[0034] 3. Make soft materials with water, granulate with 24 mesh, dry at 60°C, and granulate with 40 mesh.

[0035] 4. Add magnesium stearate, mix well, and press into tablets.

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Abstract

The invention provides oral solid preparation taking prucalopride succinate as an active ingredient, and application of the oral solid preparation. According to the method, the oral solid preparation is prepared by taking prucalopride succinate and pharmaceutically acceptable auxiliary materials and adopting the preparation technology. The solid preparation is stable in quality, controllable, convenient to take, good in compliance, and less in side effects, and is mainly used for chronic constipation in clinic practice.

Description

technical field [0001] The invention relates to an oral solid preparation of prucalopride succinate and an application thereof, belonging to the technical field of medicine. Background technique [0002] The market space for the treatment of constipation drugs is very large. In recent years, with the impact of many factors such as living standards, lifestyles, and dietary structure, coupled with the rapid increase of the elderly population, the incidence of constipation in my country is on the rise. [0003] After being approved in Europe in October 2009, prucalopride succinate was launched in Germany in January 2010 and in the UK in March 2010. Licensed by Movetis, Inc. under license from Janssen, Inc. (Johnson and a Johnson subsidiary). Prucalopride succinate is a benzamide derivative with the chemical name 4-amino-5-chloro-2,3-dihydro-N[1-(3-methoxypropyl)-4-piperidinyl ]-7-benzofurancarboxamide. It has excellent intestinal motility stimulatory effects, especially sho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4525A61P1/10
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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