Atomizing agent with arformoterol and glycopyrronium bromide serving as active components and preparation method of fogging agent

A technology of glycopyrronium bromide and active ingredients, which is applied in the field of medicine and can solve the problems of poor stability and easy degradation of arformoterol

Active Publication Date: 2017-10-10
CF PHARMTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0022] In order to solve the problem of poor stability and easy degradation of arformoterol in aqueous solution, the object of the present invention is to provide an atomizer, which uses arformoterol and glycopyrronium bromide as active ingredients and uses water as a solvent

Method used

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  • Atomizing agent with arformoterol and glycopyrronium bromide serving as active components and preparation method of fogging agent
  • Atomizing agent with arformoterol and glycopyrronium bromide serving as active components and preparation method of fogging agent
  • Atomizing agent with arformoterol and glycopyrronium bromide serving as active components and preparation method of fogging agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1 Preparation of arformoterol tartrate single atomizing agent and glycopyrrolate single atomizing agent

[0059] According to Table 1, a single atomizing agent for arformoterol tartrate and a single atomizing agent for glycopyrrolate were prepared.

[0060] Table 1

[0061]

[0062] Preparation:

[0063] Weigh the prescription amount of sodium chloride and dissolve it in an appropriate volume of water (about 700ml), stir to dissolve, add the prescription amount of arformoterol tartrate or glycopyrrolate, stir until dissolved, then add water to the full amount, add citric acid-citric acid Adjust the pH with sodium citrate buffer to obtain.

Embodiment 2

[0064] Example 2 Preparation of arformoterol tartrate and glycopyrrolate compound atomizing agent

[0065] Prepare arformoterol tartrate and glycopyrrolate compound atomizer according to Table 2.

[0066] Table 2

[0067]

[0068] Preparation:

[0069] Weigh the prescription amount of sodium chloride and dissolve it in an appropriate volume of water (about 700ml), stir to dissolve, add the prescription amount of arformoterol tartrate and glycopyrrolate, stir until dissolved, then add water to the full amount, add citric acid-citric acid Adjust the pH with sodium citrate buffer to obtain.

Embodiment 3

[0070] Example 3 Investigation of the dosage of arformoterol tartrate and glycopyrrolate in the compound atomizer

[0071] According to the preparation method of Example 2, the arformoterol tartrate and glycopyrrolate compound atomizer in Table 3 below was prepared.

[0072] table 3

[0073]

[0074] Take five compound atomizers of arformoterol tartrate and glycopyrrolate prepared according to Table 3 and place them at 40℃±2℃ / 75%RH±5%RH for 1 month, and then take samples to determine the content of the main drug T 0 The content is taken as 100%). The results of the accelerated test at 40°C±2°C / 75%RH±5%RH for one month are shown in Table 4 below.

[0075] Table 4

[0076]

[0077] The results show that, in the compound atomizing agent of arformoterol tartrate and glycopyrrolate of the present invention, the preferred dosage of arformoterol tartrate is 11 μg / mL, and the preferred dosage of glycopyrrolate is 18 μg / mL.

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Abstract

The invention relates to an atomizing agent with arformoterol and glycopyrronium bromide serving as active components and a preparation method of the atomizing agent. The invention further relates to an application of glycopyrronium bromide in improving the stability of an arformoterol water solution. Arformoterol and glycopyrronium bromide can perform a synergistic function pharmacologically while glycopyrronium bromide is used for improving the stability of arformoterol, and accordingly, the local treatment function on the lung is improved.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to an atomizer with arformoterol and glycopyrrolate as active ingredients and a preparation method thereof. The invention also relates to the application of glycopyrrolate to improve the stability of the arformoterol aqueous solution. Background technique [0002] In recent years, due to air pollution, smoking, aging population and other factors, the incidence and mortality of chronic respiratory diseases have increased significantly. Common chronic respiratory diseases include chronic obstructive pulmonary disease (COPD, referred to as chronic obstructive pulmonary disease), bronchial asthma, lung infections and lung cancer. The incidence of COPD in China is as high as 8.2%, and the incidence in the United States is as high as 14%. COPD is a disease characterized by chronic progressive airflow obstruction, mainly including chronic bronchitis, chronic obstructive emphysema,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K47/22A61K47/26A61K47/44A61K47/12A61K47/02A61K31/167A61K31/40A61P11/00A61P11/06A61P31/00
CPCA61K9/0073A61K31/167A61K31/40A61K47/02A61K47/12A61K47/22A61K47/26A61K47/44A61K2300/00
Inventor 陈琴
Owner CF PHARMTECH
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