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Trimebutine maleate dispersible tablet and preparation method thereof

A technology of trimebutine maleate and dispersible tablets, applied in the field of trimebutine maleate dispersible tablets and its preparation, can solve the problem of low stability and bioavailability of trimebutine maleate dispersible tablets Low, incomplete release and other problems, to achieve the effect of facilitating industrial production, simple preparation method, and rapid dissolution

Active Publication Date: 2019-12-27
ZHEJIANG ANGLIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The tablet formula prepared by this patented technology is simple and low in production cost, but the release in different in vitro environments is incomplete and the bioavailability is low
[0007] The Chinese patent of CN1927185A discloses a trimebutine maleate sustained-release tablet with an immediate-release part and its preparation process. The preparation process includes a double-layer tablet and a sustained-release tablet made of distributed granulation and mixed compression. The process complex and expensive
Trimebutine maleate tastes bitter, and the tablet prepared by this patented technology can completely cover the bitter taste of trimebutine maleate by compounding flavoring agent and sweetener, but trimebutine maleate Easy to degrade, the stability of the trimebutine maleate dispersible tablet prepared by this method is not high

Method used

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  • Trimebutine maleate dispersible tablet and preparation method thereof
  • Trimebutine maleate dispersible tablet and preparation method thereof
  • Trimebutine maleate dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041]

[0042] Preparation:

[0043] 1) Weigh the raw materials and auxiliary materials according to the prescription quantity, and the auxiliary materials are passed through an 80-mesh sieve;

[0044] 2) Weigh the prescribed amount of purified water, add the prescribed amount of hydroxypropyl cellulose, stir and dissolve to form a binder with a concentration of 5%;

[0045] 3) adding trimebutine maleate, lactose monohydrate, pregelatinized starch and tartaric acid into the wet granulator for premixing in sequence, and then adding the binder for wet granulation;

[0046] 4) After drying in an oven, pass through a 18-mesh sieve for granulation, and add additives for total mixing;

[0047] 5) Tablets.

Embodiment 2

[0049]

[0050] Preparation:

[0051] 1) Weigh the raw and auxiliary materials according to the prescription amount, and the auxiliary materials are passed through an 80-mesh sieve;

[0052] 2) Weigh the prescribed amount of purified water, add the prescribed amount of hydroxypropyl cellulose, stir and dissolve to form a binder with a concentration of 5%;

[0053] 3) adding trimebutine maleate, lactose monohydrate, pregelatinized starch and tartaric acid into the wet granulator for premixing in sequence, and then adding the binder for wet granulation;

[0054]4) After drying in an oven, pass through a 18-mesh sieve for granulation, and add additives for total mixing;

[0055] 5) Tablets.

Embodiment 3

[0057]

[0058]

[0059] Preparation:

[0060] 1) Weigh the raw and auxiliary materials according to the prescription amount, and the auxiliary materials are passed through an 80-mesh sieve;

[0061] 2) Weigh the prescribed amount of purified water, add the prescribed amount of hydroxypropyl cellulose, stir and dissolve to form a binder with a concentration of 5%;

[0062] 3) adding trimebutine maleate, lactose monohydrate, pregelatinized starch and tartaric acid into the wet granulator for premixing in sequence, and then adding the binder for wet granulation;

[0063] 4) After drying in an oven, pass through a 18-mesh sieve for granulation, and add additives for total mixing;

[0064] 5) Tablets.

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Abstract

The invention relates to a trimebutine maleate dispersible tablet and a preparation method thereof, and belongs to the technical field of medical supplies characterized by used non-effective components. The trimebutine maleate dispersible tablet is prepared from trimebutine maleate, auxiliary materials and additives for adjusting the whole uniformity and dispersibility of the tablet, wherein the auxiliary materials and the additives are added by taking trimebutine maleate as a reference, and the auxiliary materials are prepared from lactose, starch and hypromellose E5. The trimebutine maleatedispersible tablet provided by the invention has the advantages of stable release performance, high bioavailability and the like in different in vitro environments when being applied to processing ofpreparations for conditioning functional disturbances of gastrointestinal tracts.

Description

technical field [0001] The invention relates to a trimebutine maleate dispersible tablet and a preparation method thereof, belonging to the technical field of medical preparations characterized by non-active ingredients used. Background technique [0002] Trimebutine maleate is the original research of Pfizer, and it has been marketed all over the world. It is a non-competitive anticonvulsant with obvious anti-serotonin effect, does not affect the normal gastrointestinal motility, and can regulate abnormal motility in both directions. It is suitable for the improvement of symptoms such as loss of appetite, nausea, vomiting, belching, abdominal distension, borborygmi, abdominal pain, diarrhea, constipation and other symptoms caused by gastrointestinal motility disorders caused by gastrointestinal motility disorders, irritable bowel syndrome, curative effect better. [0003] The chemical name of trimebutine maleate is 3,4,5-trimethoxybenzoic acid (2-dimethylamino-2-phenyl)bu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/24A61K47/04A61K47/02A61K47/38A61K47/26A61K47/36A61P1/14A61P1/08A61P1/00A61P1/10A61P1/12
CPCA61K9/2009A61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K31/24
Inventor 伊骏李欣严立勇徐成苗蒋震山杨国栋方南平
Owner ZHEJIANG ANGLIKANG PHARMA
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