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Atomized salbutamol solution for treating respiratory diseases and preparation method thereof

A technology for albuterol and respiratory diseases, applied in the field of atomized albuterol solution, can solve the problems of increasing the risk of clinical drug use, affecting product quality, and difficult to repair and protect the mucosa in the lungs, so as to reduce the risk of clinical drug use and improve drug use. The effect of safety and excellent stability

Inactive Publication Date: 2019-07-26
南京望知星医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to make the solution exhibit better long-term stability, auxiliary materials such as preservatives, stabilizers, antioxidants, osmotic pressure regulators, metal ion complexing agents (edetate disodium) are usually added, and the addition of the above auxiliary materials Played the effect of improving the stability of salbutamol sulfate atomized inhalation solution, but the addition of many auxiliary materials has influenced the quality of product, has increased the risk of clinical medication, in addition, existing atomized salbutamol solution is difficult to repair lung inner mucous membrane protect and protect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] An atomized salbutamol solution for treating respiratory diseases, made of the following raw materials in parts by weight: 45.0 parts of salbutamol, 48.0 parts of pH regulator, 15.6 parts of budesonide, 18.5 parts of terbutaline, 20.6 parts of vitamins and pure 96.5 parts of water.

[0022] The present invention is an atomized salbutamol solution for treating respiratory diseases. The preparation process of said salbutamol is as follows: first put salicylaldehyde, tert-butylamine and ethanol into a reaction kettle, heat, stir and reflux to recover the solvent under reduced pressure, and then recycle the solvent in the solvent Add benzene and thionyl chloride to the mixture, and continue to stir, then filter and wash with benzene to obtain N,N-dimethyl chlorosulfate methylene ammonium solid, then add chloroacetic acid and dichloroethane to the solid, Stir at room temperature, then add water layer, wash with saturated sodium chloride solution and water, anhydrous Na 2 SO...

Embodiment 2

[0034] An atomized salbutamol solution for treating respiratory diseases, made of the following raw materials in parts by weight: 54.5 parts of salbutamol, 35.2 parts of a pH regulator, 24.0 parts of budesonide, 14.3 parts of terbutaline, 32.0 parts of vitamins and pure 85.6 parts of water.

[0035] The present invention is an atomized salbutamol solution for treating respiratory diseases. The preparation process of said salbutamol is as follows: first put salicylaldehyde, tert-butylamine and ethanol into a reaction kettle, heat, stir and reflux to recover the solvent under reduced pressure, and then recycle the solvent in the solvent Add benzene and thionyl chloride to the mixture, and continue to stir, then filter and wash with benzene to obtain N,N-dimethyl chlorosulfate methylene ammonium solid, then add chloroacetic acid and dichloroethane to the solid, Stir at room temperature, then add water layer, wash with saturated sodium chloride solution and water, anhydrous Na 2 ...

Embodiment 3

[0047] An atomized salbutamol solution for treating respiratory diseases, made of the following raw materials in parts by weight: 48.5 parts of salbutamol, 38.0 parts of pH regulator, 19.0 parts of budesonide, 16.5 parts of terbutaline, 22.0 parts of vitamins and pure 86.5 parts of water.

[0048] The present invention is an atomized salbutamol solution for treating respiratory diseases. The preparation process of the salbutamol is as follows: firstly, salicylaldehyde, tert-butylamine and ethanol are put into a reaction kettle, and the solvent is recovered under reduced pressure after heating, stirring and reflux; Add benzene and thionyl chloride to the mixture, and continue to stir, then filter and wash with benzene to obtain N,N-dimethyl chlorosulfate methylene ammonium solid, then add chloroacetic acid and dichloroethane to the solid, Stir at room temperature, then add water layer, wash with saturated sodium chloride solution and water, anhydrous Na 2 SO 4 Dry and filter,...

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Abstract

The invention discloses an atomized salbutamol solution for treating respiratory diseases and a preparation method thereof and relates to the field of atomized salbutamol solution preparation. The atomized salbutamol solution is prepared from, by weight, 45.0-54.5 parts of salbutamol, 35.2-48.0 parts of pH regulator, 15.6-24.0 parts of budesonide, 14.3-18.5 parts of terbutaline, 20.6-32.0 parts ofvitamin and 85.6-96.5 parts of purified water. Compared with the prior art, the atomized salbutamol solution has the advantages that by adopting budesonide, terbutaline and vitamin, repair and protection of intrapulmonary mucosa are realized without impact on respiratory disease treatment; the salbutamol atomized inhalation solution has excellent stability, is little in related substance contentand simple in composition, risk of clinical medication is lowered, medication safety is improved, and the atomized salbutamol solution is simple in preparation process and has wide market prospect.

Description

technical field [0001] The invention relates to the technical field of atomized salbutamol solution, in particular to an atomized salbutamol solution for treating respiratory diseases and a preparation method thereof. Background technique [0002] Salbutamol sulfate nebulized inhalation solution Salbutamol sulfate nebulized inhalation solution, chemical name: hemisulfate of 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol, molecular formula: C13H21NO3. 1 / 2H2SO4, this product is a selective β2-adrenergic receptor agonist, its mechanism of action is to stimulate intracellular adenylate cyclase through the action on β-adrenergic receptors, and increase the concentration of cyclic adenosine monophosphate level, relax bronchial smooth muscle, and inhibit mediator release from immediate hypersensitivity cells (especially mast cells). Most well-controlled clinical trials have shown that albuterol has stronger respiratory effects (relaxation of bronchial smooth muscle...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K31/07A61K31/137A61K31/198A61K31/205A61K31/355A61K31/525A61K31/58A61K31/592A61K47/12A61P11/00
CPCA61K9/0073A61K31/07A61K31/137A61K31/198A61K31/205A61K31/355A61K31/525A61K31/58A61K31/592A61K47/12A61P11/00A61K2300/00
Inventor 王莹国
Owner 南京望知星医药科技有限公司
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