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Salbutamol sulfate aerosol inhalation solution, and preparation process and application thereof

A salbutamol sulfate, preparation technology, applied in the direction of liquid transportation, dispersion liquid transportation, respiratory diseases, etc., can solve the problems of poor atomization performance and achieve good atomization performance and good thermal stability

Pending Publication Date: 2021-02-26
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The purpose of the present invention is to overcome the poor atomization performance of salbutamol sulfate solution for inhalation in the prior art, and provide a kind of salbutamol sulfate atomized inhalation solution and its preparation process and application

Method used

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  • Salbutamol sulfate aerosol inhalation solution, and preparation process and application thereof
  • Salbutamol sulfate aerosol inhalation solution, and preparation process and application thereof
  • Salbutamol sulfate aerosol inhalation solution, and preparation process and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription:

[0044]

[0045]

[0046] Preparation process: Take 90% of the prescribed amount of water for injection, add the main drug and osmotic pressure regulator in the prescribed amount, stir for 20 minutes, adjust the pH value to 3.5-4.5 with a pH regulator, add water to the full amount, pass the liquid medicine through a 0.45 μm coarse Filter, 0.22μm fine filter. Then the filtered medicinal solution is divided into 2-5ml plastic ampoules by BFS, sterilized by high pressure steam at 121 degrees centigrade for 15 minutes, inspected by light and packaged to obtain the salbutamol sulfate atomized inhalation solution preparation.

Embodiment 2

[0048] prescription:

[0049]

[0050] Preparation process: Take 90% of the prescribed amount of water for injection, add the main drug and osmotic pressure regulator in the prescribed amount, stir for 20 minutes, adjust the pH value to 3.5-4.5 with a pH regulator, add water to the full amount, pass the liquid medicine through a 0.45 μm coarse Filter, 0.22μm fine filter. Then the filtered medicinal solution is subpackaged into 2-5ml plastic ampoules by BFS, sterilized by high pressure steam at 115 degrees centigrade for 30 minutes, inspected by light and packaged to obtain the salbutamol sulfate atomized inhalation solution preparation.

Embodiment 3

[0052] prescription:

[0053]

[0054]

[0055] Preparation process: Take 90% of the prescribed amount of water for injection, add the main drug and osmotic pressure regulator in the prescribed amount, stir for 20 minutes, adjust the pH value to 3.5-4.5 with a pH regulator, add water to the full amount, pass the liquid medicine through a 0.45 μm coarse Filter, twice 0.22μm fine filter. Then the filtered medicinal solution is divided into 2-5ml plastic ampoules by BFS, inspected by light and packaged to obtain the salbutamol sulfate atomized inhalation solution preparation.

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PUM

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Abstract

The invention discloses a salbutamol sulfate aerosol inhalation solution, and a preparation process and application thereof. The salbutamol sulfate solution is prepared from the following components:salbutamol sulfate, an osmotic pressure regulator, a pH regulator and water for injection, wherein the pH value of the salbutamol sulfate solution is 3.0 to 5.0. The salbutamol sulfate solution has good atomization performance and thermal stability.

Description

technical field [0001] The invention relates to a salbutamol sulfate atomized inhalation solution and a preparation process and application thereof. Background technique [0002] Asthma and chronic obstructive pulmonary disease (COPD) have become the two most common respiratory diseases worldwide. According to the WHO forecast, by 2025, the number of asthma patients in the world will increase to 400 million. In terms of chronic pulmonary obstructive COPD, according to the important paper "China Lung Health [CPH] Research: A National Cross-sectional Study" by Academician Wang Chen, the prevalence of COPD in adults aged 20 and over in my country is 8.6%, and it reaches 8.6% for adults over 40 years old. 13.7%, the prevalence rate of people over 60 years old has exceeded 27%, and the total number of patients in the country is 99.9 million. COPD has become the most common chronic disease on a par with hypertension and diabetes, constituting a major disease burden in my country. ...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K31/137A61P11/06A61P11/00
CPCA61K9/0078A61K9/08A61K47/02A61K31/137A61P11/06A61P11/00Y02A50/30
Inventor 周雅茹邵奇王刘国洪晨荆志欣孙宁云文彬王嬿
Owner SHANGHAI SINE PHARMA LAB
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