Procaterol hydrochloride oral liquid and preparation method thereof

A technology of procaterol hydrochloride oral liquid and citric acid, applied in the field of medicine, can solve problems such as easy degradation and poor stability, achieve the effects of stabilizing the solution system, ensuring stability, and avoiding the influence of degradation by-products

Pending Publication Date: 2022-05-10
澳美制药(苏州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of this application is to provide a kind of procaterol hydrochloride oral liquid and its preparation method, aiming to solve the technical problem of poor stability and easy degradation of existing procaterol hydrochloride oral liquid

Method used

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  • Procaterol hydrochloride oral liquid and preparation method thereof
  • Procaterol hydrochloride oral liquid and preparation method thereof
  • Procaterol hydrochloride oral liquid and preparation method thereof

Examples

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preparation example Construction

[0047] as attached figure 1 Shown, the second aspect, the embodiment of the present application provides a kind of preparation method of procaterol hydrochloride oral liquid, it is characterized in that, comprises the following steps:

[0048] S10. Combine 0.0025-0.0075 parts of ethylparaben, 0.00125-0.00375 parts of butylparaben, 0.01-1.0 parts of essence, 0.05-0.4 parts of sodium benzoate, 25-50 parts of flavoring agent and 1.5-5.0 parts of Parts of solvent and 41 to 73 parts of water are mixed to obtain a mixed solution;

[0049] S20. Dissolving 0.1-2.0 parts of citric acid and 0.05-1.0 parts of citrate in the mixed solution to obtain a buffer solution;

[0050] S30. Dissolving 0.0005-0.001 part of Procaterol Hydrochloride in the buffer solution to obtain Procaterol Hydrochloride Oral Liquid.

[0051] The preparation method of Procaterol Hydrochloride Oral Liquid provided by the second aspect of the embodiment of the present application, dissolves the ethylparaben, butylp...

Embodiment 1

[0068] A kind of procaterol hydrochloride oral liquid, its preparation method comprises the steps:

[0069] Dissolve the alcohol-soluble excipients ethylparaben 0.005%, butylparaben 0.0025%, and essence 0.5% in ethanol with a recipe volume of 2.5%; the water-soluble excipients sodium benzoate 0.2% and sucrose 35% are completely dissolved in In water, then the two systems were miscible and stirred until completely clear; 0.2% citric acid and 0.1% trisodium citrate were used to adjust the pH value to 4.0; the main drug Procaterol hydrochloride (0.0005%) was added to the buffer solution, Dissolving and constant volume; filling after filtration to obtain Procaterol Hydrochloride Oral Liquid.

Embodiment 2

[0071] A kind of procaterol hydrochloride oral liquid, its preparation method comprises the steps:

[0072]Dissolve the alcohol-soluble excipients ethylparaben 0.005%, butylparaben 0.0025%, and essence 0.5% in ethanol with a recipe volume of 2.5%; the water-soluble excipients sodium benzoate 0.2% and sucrose 35% are completely dissolved in In water, then the two systems were miscible and stirred until completely clear; 0.9% citric acid and 0.35% trisodium citrate were used to adjust the pH value to 3.2; the main drug Procaterol hydrochloride (0.0005%) was added to the buffer solution, Dissolving and constant volume; filling after filtration to obtain Procaterol Hydrochloride Oral Liquid.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to procaterol hydrochloride oral liquid and a preparation method thereof. The procaterol hydrochloride oral liquid is prepared from the following raw material components in percentage by mass: 0.0005 percent to 0.001 percent of procaterol hydrochloride, 0.0025 percent to 0.0075 percent of ethylparaben, 0.00125 percent to 0.00375 percent of butyl paraben, 0.01 percent to 1.0 percent of essence, 1.5 percent to 5.0 percent of a solvent, 0.05 percent to 0.4 percent of sodium benzoate, 0.1 percent to 2.0 percent of citric acid, 0.05 percent to 1.0 percent of citrate, 25 percent to 50 percent of a flavoring agent and the balance of water, wherein the total mass of the procaterol hydrochloride oral liquid is 100 percent. According to the procaterol hydrochloride oral liquid, the stability of the procaterol hydrochloride oral liquid is ensured through the synergistic effect of all the raw material components and the mass percentage content, the risk of degradation of active ingredients of procaterol hydrochloride is effectively reduced, and the stability and the curative effect of the oral liquid are improved.

Description

technical field [0001] The application belongs to the technical field of medicines, in particular to a procaterol hydrochloride oral liquid and a preparation method thereof. Background technique [0002] Procaterol hydrochloride, the chemical name is 5-(1-hydroxy-2-isopropylaminobutyl)-8-hydroxyquinolone hydrochloride hemihydrate, the molecular formula is C 16 h 22 N 2 o 3 ·HCl·1 / 2H 2 O. Its pharmacological classification is long-acting beta 2 Receptor agonist, mainly by selectively activating airway smooth muscle cell surface β 2 Adrenergic receptors, thereby relaxing airway smooth muscle, relieving airway spasm, and reducing airway mucosal congestion and edema, clinically used to relieve airway obstruction in diseases such as bronchial asthma, chronic bronchitis, acute bronchitis, and asthmatic bronchitis Symptoms such as dyspnea caused by the disorder. beta 2 Receptor agonists are currently the most widely used and most diverse bronchodilators in clinical practic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4704A61K47/14A61K47/12A61K47/26A61K47/10A61P11/06A61P11/00
CPCA61K9/0095A61K31/4704A61K47/14A61K47/12A61K47/26A61K47/10A61P11/06A61P11/00
Inventor 黄振君朱爱军魏建华张兆珍曹丽丽
Owner 澳美制药(苏州)有限公司
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