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Low-refrigeration-effect composite propellant for inhalation aerosol as well as preparation method and application of low-refrigeration-effect composite propellant

A propellant and unilateral technology, applied in the direction of aerosol delivery, medical preparations of non-active ingredients, pharmaceutical formulations, etc., can solve the problem of drug-containing aerosol settlement and adhesion, reduction of drug dose in the patient's respiratory system, delay in treatment timing, etc. question

Pending Publication Date: 2022-05-24
JINAN UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this strategy can play an evasive role, there are still several limitations: (1) the inhalation aerosol pressure-resistant container of each brand must be combined with the spacer with a special connection port, and the design of the special connection port and The time and economic cost of production are high; (2) The medicated aerosol may have unstable phenomena such as sedimentation and adhesion in the spacer, and the amount of medicine entering the patient's respiratory system will be reduced; (3) When training patients to use the spacer Need to consume additional medical resources; (4) For some clinical application scenarios such as first aid, the use of spacers may delay the timing of treatment

Method used

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  • Low-refrigeration-effect composite propellant for inhalation aerosol as well as preparation method and application of low-refrigeration-effect composite propellant
  • Low-refrigeration-effect composite propellant for inhalation aerosol as well as preparation method and application of low-refrigeration-effect composite propellant
  • Low-refrigeration-effect composite propellant for inhalation aerosol as well as preparation method and application of low-refrigeration-effect composite propellant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Example 1: Preparation of glucose-ethanol-HFA134a composite propellant

[0078] Glucose and ethanol were sequentially added to a 10 mL aluminum pressure-resistant container, and then placed in an air-bath stirring box at 25° C. and stirred at a rate of 50 rpm. Then use a sealing machine to install a 50 μL quantitative valve on the pressure-resistant container, and use a propellant filling machine to fill the aluminum pressure-resistant container with HFA134a, and then stir at a rate of 50 rpm in an air bath stirring box at 25 °C.

[0079] Systems 1-4 and A-C were prepared through the above steps. The mass ratio of glucose-ethanol-HFA134a in system 1 is 0.05:5:94.95; the mass ratio of glucose-ethanol-HFA134a in system 2 is 0.1:5:94.9; the mass ratio of glucose-ethanol-HFA134a in system 3 is 0.1:10: 89.9; the mass ratio of glucose-ethanol-HFA134a in system 4 is 0.2:10:89.8; the mass ratio of glucose-ethanol-HFA134a in system A is 0.8:5:94.2; the mass ratio of glucose-eth...

Embodiment 2

[0102] Example 2: Preparation of mannose-tert-butanol-HFA227 composite propellant

[0103] Mannose and tert-butanol were sequentially added to a 10 mL aluminum pressure-resistant container, and the mixture was placed in a 30° C. air-bath stirring box and stirred at a speed of 100 rpm. Then use a sealing machine to install a 50 μL quantitative valve on the pressure-resistant container, fill HFA227 into the aluminum pressure-resistant container with a propellant filling machine, and then stir at a rate of 100 rpm in an air bath stirring box at 30 °C.

[0104] Systems 5-8 were prepared through the above steps. The mass ratio of mannose-tert-butanol-HFA227 in system 5 is 0.01:1:98.99; the mass ratio of mannose-tert-butanol-HFA227 in system 6 is 0.02:1:98.98; the mannose-tert-butanol in system 7 The mass ratio of -HFA227 is 0.02:2:97.98; the mass ratio of mannose-tert-butanol-HFA227 in system 8 is 0.04:2:97.96. The total mass of mannose, tert-butanol and HFA227 in each system is ...

Embodiment 3

[0109] Example 3: Preparation of fructose-ethanol / isopropanol-HFA134a composite propellant

[0110] Fructose, ethanol and isopropanol were sequentially added to a 10 mL aluminum pressure-resistant container, and placed in a 20° C. air-bath stirring box to stir at a rate of 25 rpm. Then use a sealing machine to install a 50 μL quantitative valve on the pressure-resistant container, pour HFA134a into the aluminum pressure-resistant container with a propellant filling machine, and then stir at a rate of 25 rpm in an air bath stirring box at 20 °C.

[0111] Systems 9-14 were prepared by the above steps. The ethanol-isopropanol mass ratio in system 9 is 3:2, the fructose-ethanol / isopropanol-HFA134a mass ratio is 0.01:2:97.99; the ethanol-isopropanol mass ratio in system 10 is 1:1, fructose-ethanol / isopropanol-HFA134a mass ratio is 1:1 -The mass ratio of ethanol / isopropanol-HFA134a is 0.01:2:97.99; in system 11, the mass ratio of ethanol-isopropanol is 1:2, and the mass ratio of fr...

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Abstract

The invention relates to a low-refrigeration-effect composite propellant for inhalation aerosol as well as a preparation method and application of the low-refrigeration-effect composite propellant. The composite propellant is prepared from a unilateral propellant, monosaccharide and short-chain alcohol according to the following mass ratio: 89.8 to 98.99 percent of unilateral propellant, 0.01 to 0.2 percent of monosaccharide and 1 to 10 percent of short-chain alcohol, the single propellant is HFA134a and / or HFA227, and the particle size of the single propellant is 100-200nm; the monosaccharide is selected from at least one of C5-C6 monosaccharides; the short-chain alcohol is selected from at least one of C2-C4 alkyl alcohols. The composite propellant is low in refrigeration effect, small in irritation to patients with respiratory diseases and capable of improving compliance of the patients and promoting clinical application of inhalation aerosol.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound propellant with low refrigeration effect for inhaling aerosols, a preparation method and application thereof. Background technique [0002] Inhalation aerosol is a kind of pulmonary inhalation drug delivery preparation consisting of a drug, a propellant and a pressure-resistant container. In recent years, inhalation aerosols for the delivery of anti-infective, anti-fibrotic and anti-tumor drugs have also entered the laboratory or preclinical stage. Due to the low cost of preparation, inhalation aerosols have high potential for industrial transformation. However, the current share of inhalation aerosols in the pulmonary inhalation formulation market is only about 36% (2021 data). An important reason for the low market share of inhaled aerosols is that the respiratory irritation induced by the cooling effect of propellants seriously affects patient ...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K47/06A61K47/10A61K47/26
CPCA61K9/124A61K9/008A61K47/26A61K47/10A61K47/06
Inventor 黄郑炜张雪娟吴传斌潘昕黄莹付芳琴白雪群王文浩
Owner JINAN UNIVERSITY
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