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Itopride hydrochloride sustained release preparation and preparation method thereof

A technology of itopride hydrochloride and sustained-release preparations, applied in the field of chemical medicine, can solve the problems of weak dopamine D2 receptor blocking effect, no pharmacological correlation, etc., and achieve the effect of delaying drug effect

Inactive Publication Date: 2020-03-24
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Itopride hydrochloride is converted into metabolites M1, M2 and M3 mainly through the flavin monooxygenase pathway in the liver. Among the three metabolites, only one of them has a weak dopamine D2 receptor blocking effect, and has no pharmacological relevance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Itopride hydrochloride sustained-release preparation, calculated by weight, includes 50 parts of itopride hydrochloride 4, 40 parts of hypromellose K100, 20 parts of hypromellose E5, 20 parts of microcrystalline Cellulose, 20 parts of lactose, 1 part of magnesium stearate.

[0026] Utilize above-mentioned components to prepare itopride hydrochloride sustained-release preparation, the steps are:

[0027] The steps are:

[0028] S1. First mix itopride hydrochloride, lactose and part of magnesium stearate with water to prepare wet granules of 1~2mm, and let it stand for 2~5h to dry slightly. It is required that the slightly dry wet granules after standing are not easy to crack easily open but not completely uncracked;

[0029] S2. Add hypromellose K100 and hypromellose E5 to the wet granules after micro-drying in step S1 in sequence, mix well and stir, so that the wet granules are wrapped with hypromellose K100 and hypromellose Prime E5;

[0030] S3, then add microcrys...

Embodiment 2

[0034] Itopride hydrochloride sustained-release preparation, calculated by weight, includes 100 parts of itopride hydrochloride, 50 parts of hypromellose K100, 40 parts of hypromellose E5, and 30 parts of microcrystalline cellulose Vegetarian, 30 parts of lactose, 2 parts of magnesium stearate.

[0035] Utilize above-mentioned components to prepare itopride hydrochloride sustained-release preparation, the steps are:

[0036] The steps are:

[0037] S1. First mix itopride hydrochloride, lactose and part of magnesium stearate with water to prepare wet granules of 1~2mm, and let it stand for 2~5h to dry slightly. It is required that the slightly dry wet granules after standing are not easy to crack easily open but not completely uncracked;

[0038] S2. Add hypromellose K100 and hypromellose E5 to the wet granules after micro-drying in step S1 in sequence, mix well and stir, so that the wet granules are wrapped with hypromellose K100 and hypromellose Prime E5;

[0039] S3, the...

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PUM

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Abstract

The invention discloses a itopride hydrochloride sustained release preparation which is prepared from the following components in parts by weight: 50 to 100 parts of itopride hydrochloride, 40 to 50 parts of hydroxypropyl methylcellulose K100, 20 to 40 parts of hydroxypropyl methylcellulose E5, 20 to 30 parts of microcrystalline cellulose, 20 to 30 parts of lactose and 1 to 2 parts of magnesium stearate. The invention further discloses a preparation method thereof. The preparation method has the beneficial effects that the preparation is convenient, and the effective components of prepared tablets are slowly released.

Description

technical field [0001] The invention relates to the field of chemical medicine, in particular to an itopride hydrochloride sustained-release preparation and a preparation method thereof. Background technique [0002] Itopride hydrochloride has dopamine D2 receptor antagonistic activity and acetylcholinesterase inhibitory activity, and exerts gastrointestinal prokinetic effect through the synergistic effect of the two; in addition, due to the effect of antagonizing dopamine D2 receptor activity, this product still has certain It is clinically used for dyspepsia symptoms caused by slowed gastrointestinal motility (such as functional dyspepsia, chronic gastritis, etc.), including epigastric fullness, epigastric pain, loss of appetite, nausea and vomiting Wait. Itopride hydrochloride is converted into metabolites M1, M2 and M3 mainly through the flavin monooxygenase pathway in the liver. Among the three metabolites, only one of them has a weak dopamine D2 receptor blocking effe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/16A61K47/38A61K47/12A61K47/26A61K31/166A61P1/08A61P1/14
CPCA61K9/1617A61K9/1623A61K9/2013A61K9/2054A61K9/2095A61K31/166A61P1/08A61P1/14
Inventor 刘辉
Owner CHENGDU HENGRUI PHARMA
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