Indacaterol maleate liquid preparation and preparation method thereof

A technology for indacaterol maleate and liquid preparations, which is applied in the field of indacaterol maleate liquid preparations and its preparation, and can solve problems such as poor uniformity

Inactive Publication Date: 2014-05-14
QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indacaterol maleate has better water solubility, and the present invention prepares indacaterol maleate into a liquid preparation, solves the problem of poor uniformity of indacaterol maleate in other preparation types, and provides a Indacaterol maleate liquid preparation with good uniformity and high bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: Prepare 1000 indacaterol maleate liquid capsules

[0019] Prescription: Indacaterol Maleate 0.3g Medium Chain Triglycerides 100g

[0020] Anhydrous ethanol 1.2g Dibutylhydroxytoluene 0.05g

[0021] Process:

[0022] 1. Add indacaterol maleate to the prescribed amount of absolute ethanol and stir until completely dissolved;

[0023] 2. Add dibutyl hydroxytoluene to the above solution and stir until completely dissolved;

[0024] 3. Add the prescribed amount of medium-chain triglycerides and stir evenly;

[0025] 4. Fill the solution obtained above into a hard capsule, and seal the hard capsule.

Embodiment 2

[0026] Embodiment 2: prepare 1000 indacaterol maleate liquid capsules

[0027] Prescription: indacaterol maleate 1.0g polyethylene glycol 300g

[0028] Absolute ethanol 0.8g Sodium benzoate 0.05g

[0029] Process:

[0030] 1. Add indacaterol maleate to the prescribed amount of absolute ethanol and stir until completely dissolved;

[0031] 2. Add sodium benzoate and stir in the above solution until completely dissolved;

[0032] 3. Add the prescribed amount of polyethylene glycol and stir evenly to get the product;

[0033] 4. Fill the solution obtained above into a hard capsule, and seal the hard capsule.

[0034] Dissolution Analysis

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PUM

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Abstract

The invention relates to an indacaterol maleate liquid preparation which comprises an active ingredient, a diluent and a solvent, wherein the active ingredient is indacaterol maleate, per 1,000 granules of the liquid preparation contains 0.3-0.8g of indacaterol maleate and 150-300g of diluent. The invention prepares indacaterol maleate into a liquid preparation, solves the poor homogeneity problem of indacaterol maleate in other preparations, and provides an indacaterol maleate liquid preparation with good homogeneity.

Description

field of invention [0001] The invention belongs to the field of medicaments, and in particular relates to a liquid preparation of indacaterol maleate and a preparation method thereof. Background of the invention [0002] Chronic obstructive pulmonary disease (COPD) is a serious lung disease that makes breathing difficult. Symptoms can include shortness of breath, chronic cough, and excessive phlegm. An exacerbation may last for several weeks and lead to a decline in lung insufficiency, an increased risk of death, and may be accompanied by severe anxiety. The etiology of COPD is not very clear, but experts at home and abroad believe that smoking is the most important factor causing COPD. According to the National Heart, Lung and Blood Institute report, smoking is the leading cause of COPD, and CCWD is the fourth leading cause of death in the United States. Air pollution, indoor air pollution, and passive smoking are also causes of COPD; occupational exposure to harmful gas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4704A61P11/08
Inventor 代先慧张绪伟刘英勋冷玲
Owner QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL
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