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Tegasevod maleate oral preparation and its preparation process-for curing intestinal irritability syndrome

A technology for tegaserod maleate and oral preparation, which is applied in the directions of pill delivery, drug combination, medical preparations containing active ingredients, etc., can solve problems such as low incidence and achieve the effect of stable quality

Inactive Publication Date: 2003-09-24
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The most common adverse events in the tegaserod maleate group were diarrhea, abdominal pain, and dizziness, but the incidence rates were all low (<3%)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 2

[0099] prescription:

[0100] Tegaserod maleate 6g (calculated as tegaserod)

[0101] Lactose 50g

[0102] Sucrose 25g

[0103] Cross-linked polyvinylpyrrolidone 26g

[0104] Glyceryl monostearate 8g

[0105] Poloxamer 1.5g

[0106] Polysorbate 80 1.5g

[0107] Povidone K30 2.5g

[0108] 50% ethanol solution 40ml

[0109] Makes 1000 pieces

[0110] Preparation Process:

[0111] 1. Tegaserod maleate raw materials and auxiliary materials are mixed and ground, and the grinding fineness can pass through a 200-mesh sieve. The micronization of raw materials and excipients is beneficial to the dissolution of drugs.

[0112] 2. Surfactants and adhesives are added to the wetting agent 50% ethanol, which can be heated and stirred to dissolve, so that the surfactants can be fully and evenly dispersed in the raw materials and excipients, which can help dissolve the drug and increase the concentration of the drug. dissolution.

[0113] 3....

example 3

[0115] prescription:

[0116] Tegaserod maleate 6g (calculated as tegaserod)

[0117] Cross-linked polyvinylpyrrolidone 20g

[0118] Sodium Carboxymethyl Cellulose 30g

[0119] Microcrystalline Cellulose 50g

[0120] Micronized silica gel 30g

[0121] Polyvinylpyrrolidone 20g

[0122] Polysorbate 80 2g

[0123] Sodium Lauryl Sulfate 5g

[0124] Poloxamer 2g

[0125] Mannitol 50g

[0126] Stevia 10g

[0127] Flavor Appropriate amount

[0128] Glyceryl monostearate 10g

[0129] Makes 1000 pieces

[0130] Preparation Process:

[0131] Take tegaserod maleate, mix well with auxiliary materials, and press into tablets.

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PUM

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Abstract

The present invention relates to an oral medicine preparation for curing intestinal irritability syndrome using constipatino as main sympton-tijaseluo maleate. It is made up by using tijaseluo maleate as active component and adding proper auxiliary material through a certain preparation process, and can be made into various oral dosage forms of tablet, oral disintegrant table, effervescent tablet, capsule, suspension gel and powder preparation, etc.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation process thereof, in particular to an oral preparation of tegaserod maleate, a medicine for irritable bowel syndrome whose main symptom is treating constipation, and a preparation process thereof. technical background [0002] Irritable bowel syndrome (IBS) is a common disease accompanied by abdominal pain and colon dysfunction, characterized by the absence of inflammation, the cause is unknown, diet, lifestyle factors, infection and unrelated inflammatory conditions have been considered possible At present, there is no specially approved drug and "gold standard therapy" for the treatment of IBS in the world. There are several types of IBS, with constipation being one major type. [0003] Constipation consists of a variety of symptoms, including dry, hard stools, difficulty or incomplete bowel movements, and two or fewer bowel movements a week. According to the pathophysiological ...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/20A61K9/22A61K9/48A61K31/404A61P1/00A61P1/10
Inventor 刘孝乐刘智许军彭红钱进李平朱丹
Owner HONGYI SCI & TECH CO LTD NANCHANG
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