Surface-modified salbutamol suspension type non-Freon inhalation aerosol and preparation method thereof

A technology of albuterol and surface modification, which is applied in the directions of aerosol delivery, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Easy-to-use effects

Inactive Publication Date: 2010-11-24
扬州市三药制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, compared with other preparations, it is more important and difficult to determine the fine particle dose (Fine Particle Dose, FPD) in inhalation preparations and to establish a quality control assurance system for inhalation preparations.

Method used

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  • Surface-modified salbutamol suspension type non-Freon inhalation aerosol and preparation method thereof
  • Surface-modified salbutamol suspension type non-Freon inhalation aerosol and preparation method thereof
  • Surface-modified salbutamol suspension type non-Freon inhalation aerosol and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Take 0.15mg of lecithin in 150g of absolute ethanol, dissolve it, add 100g of salbutamol sulfate with an average particle size of less than 10 microns, stir and disperse for 10 minutes, filter to remove the solvent and unadsorbed phospholipids, and dry at 50°C to obtain 100.0001g of average Particles with a particle size of 10 microns. Wherein, the weight of phospholipid is 0.0001% of the salbutamol sulfate weight.

Embodiment 2

[0062] Take 5g of soybean lecithin in 790g of absolute ethanol, after dissolving, add 100g of salbutamol sulfate with an average particle size of less than 10 microns, use a shearing machine to shear and disperse for 5 minutes, filter to remove the solvent and unadsorbed phospholipids, dry at 50°C, and air flow Pulverized to obtain 100.03 g of particles with an average particle diameter of 5 micrometers. Wherein, the weight of phospholipid is 0.03% of the salbutamol sulfate weight.

Embodiment 3

[0064] Get 0.4g of soybean lecithin in 400g of absolute ethanol, after dissolving, add 100g of levosalbutamol hydrochloride, ball mill for 20 minutes, the others are the same as in Example 2, and obtain 100.001g of particles with an average particle diameter of 2 microns. Wherein, the weight of phospholipid is 0.001% of the weight of levosalbutamol hydrochloride.

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Abstract

The invention discloses a surface-modified salbutamol suspension type non-Freon inhalation aerosol and a preparation method thereof. The surface-modified salbutamol suspension type non-Freon inhalation aerosol contains 0.001%-3% of salbutamol with surface modified by using phospholipid by total weight of the aerosol. The surface-modified salbutamol suspension type non-Freon inhalation aerosol hasthe advantages of convenient use, safety and nonirritant because natural nontoxic phospholipid is used as a surface active agent has great low content, and higher clinical application value.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a salbutamol inhalation aerosol and a preparation method thereof. Background technique [0002] Since Charles Thiel of Riker Laboratories invented the pressure metered dose inhaler (pressurized metered dose inhaler, pMDI) for the first time in 1956, in the past fifty years, due to its quick-acting, localization and avoidance of gastrointestinal first-pass effect and volume Small size, convenient administration, low price, easy to use by patients, no need for dry powder inhalers to load drugs before use or the powder in the device absorbs moisture due to environmental reasons, etc. It is the main dosage form for chronic lung disease and has advantages that cannot be replaced by other preparations. [0003] With people's increasing awareness of environmental protection, 40 countries signed the "Montreal Protocol on Substances that Deplete the Ozone Layer" in Mo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K47/24A61K9/12A61P11/00A61P11/06
Inventor 金方邓万定
Owner 扬州市三药制药有限公司
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