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Tegaserod maleate oral preparation.

A technology for oral preparations of tegaserod maleate, applied in pill delivery, medical preparations containing active ingredients, digestive system, etc., can solve problems such as unstable quality, poor dispersibility, slow dissolution, etc., and achieve improved content Uniformity, avoiding the risk of drug use, and accelerating the effect of dissolution

Inactive Publication Date: 2008-03-05
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] A number of tegaserod maleate oral preparations (tablets and capsules) have been launched or are under development at home and abroad. Due to the small size (6mg) and poor dispersion of tegaserod maleate, the dissolution is slow. Lead to unsatisfactory uniformity and dissolution rate of tegaserod maleate oral preparations, unstable quality
[0004] European patent EP0505322, Japanese patent JP5086026, U.S. patent US5510353, Chinese patent 99809924.4 and 03107856.7 and other patents related to tegaserod maleate have no suggestions for the above problems, and other known technologies have no suggestions for improving the above defects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Tegaserod Maleate 6g

[0026] Lactose 55g

[0027] Starch 25g

[0028] Crospovidone 15g

[0029] Magnesium Stearate 1g

[0030] Mix the above-mentioned amount of tegaserod maleate with lactose and starch through a 60-mesh sieve according to the equal-quantity incremental method, add 5% povidone ethanol solution to make a soft material, pass through a 18-mesh sieve to granulate, and bake at 60°C Dry, pass through a 20-mesh sieve for granulation, add crospovidone and magnesium stearate, mix evenly, take samples and measure the content of intermediates, and then compress into tablets.

Embodiment 2

[0032] Tegaserod maleate micronized 6g

[0033] Lactose 55g

[0034] Starch 25g

[0035] Crospovidone 15g

[0036] Magnesium Stearate 1g

[0037] First micronize tegaserod maleate (500 mesh), take the above-mentioned amount of tegaserod maleate micronization and mix with lactose and starch through a 60-mesh sieve, add 5% polyvinyl chloride The ketone-ethanol solution is made into a soft material, granulated through a 18-mesh sieve, dried at 60°C, granulated through a 20-mesh sieve, added with cross-linked povidone and magnesium stearate, mixed evenly, sampled and measured for intermediate content, and pressed piece.

Embodiment 3

[0039] Tegaserod maleate micronized 6g

[0040] Lactose 55g

[0041] Starch 25g

[0042] Crospovidone 15g

[0043] Magnesium Stearate 1g

[0044] First, tegaserod maleate is pulverized by airflow pulverization (2000 mesh), and the above-mentioned amount of tegaserod maleate micronization is mixed with lactose and starch through a 60-mesh sieve in equal amounts, and then added to 5 % povidone ethanol solution to make soft material, granulate through 18 mesh sieve, dry at 60°C, granulate through 20 mesh sieve, add crospovidone and magnesium stearate, mix evenly, take samples and determine intermediates Tablet after content.

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Abstract

An orally taken powder of Tijiaseluo maleate for treating constipation-type intestinovulnerable syndrome contains proportionally the superfine powder of Tijiaseluo maleate or its composition and the biologically acceptable auxiliary chosen from excipient, disintegrant and water-soluble polymer.

Description

technical field [0001] An oral preparation of tegaserod maleate of the present invention relates to an oral preparation containing micronized product of tegaserod maleate or a micronized product of tegaserod maleate composition, which is used for constipation-type irritable bowel Short-term treatment for the relief of symptoms in patients with the syndrome. Background technique [0002] Tegaserod maleate is an indole selective 5-HT4 receptor partial agonist, which stimulates gastrointestinal motility reflex and intestinal secretion by stimulating 5-HT4 receptors in the gastrointestinal tract, and inhibits visceral sensitivity. Tegaserod maleate has high affinity to human 5-HT4 receptors, but no significant affinity to 5-HT3 receptors or dopamine receptors. Tegaserod maleate acts as a partial agonist of neuronal 5-HT4 receptors, stimulating further release of neurotransmitters such as calcitonin gene-related peptide from sensory neurons. In vivo experiments have shown that ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/404A61K9/20A61K9/48A61P1/00A61P43/00
Inventor 叶东李晓昕戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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