Ambrisentan aerosol inhalation solution and preparation method thereof

An ambrisentan and aerosol inhalation technology, applied in the field of pharmacy, can solve problems such as the inability to achieve drug delivery, and achieve the effects of ensuring sterility, easy control, and accurate dosing

Pending Publication Date: 2022-05-20
INCREASEPHARM TIANJIN INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the powder spray needs to rely on the patient's large inspiratory flow rate to start the nebulization, and the patient cannot achieve drug delivery under normal breathing conditions, so it is not suitable for children, the elderly and other patients who have difficulty breathing actively

Method used

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  • Ambrisentan aerosol inhalation solution and preparation method thereof
  • Ambrisentan aerosol inhalation solution and preparation method thereof
  • Ambrisentan aerosol inhalation solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] prescription composition

[0067] name composition Ambrisentan 2.0g Sodium chloride 7.5g Sodium citrate 3.0g sodium hydroxide Adjust pH to 8.0 Add water for injection to 1000ml

[0068] Preparation:

[0069] Measure 800ml of water for injection (80% of the prescribed amount), heat up to 70°C and keep warm, add the prescribed amount of sodium chloride and sodium citrate in turn, stir and dissolve, put in ambrisentan, continue stirring to dissolve, add sodium hydroxide Adjust the pH value of the solution to 8.0, stir evenly, make up to the full amount with a solvent, filter with a 0.22 μm filter membrane or filter element, fill it into a 5ml ampoule bottle, and seal it to obtain the product.

Embodiment 2

[0071] prescription composition

[0072]

[0073]

[0074] Preparation:

[0075] Measure water for injection 700ml (70% of prescription quantity), heat up to 50 ℃ and keep warm, drop into prescription quantity sodium chloride, sodium citrate successively, drop into Ambrisentan after stirring and dissolving, continue stirring to dissolve, after stirring evenly ( The pH value is 6.5), the solvent is added to the full amount, filtered with a 0.22 μm filter membrane or a filter element, filled into a 1ml ampoule bottle, sealed, and obtained.

Embodiment 3

[0077] prescription composition

[0078] name composition Ambrisentan 2.0g glucose 40g sodium bicarbonate 10g sodium hydroxide Adjust pH to 10.0 Add water for injection to 1000ml

[0079] Preparation:

[0080] Measure 600ml of water for injection (60% of the prescription amount), heat up to 60°C and keep warm, put in the prescription amount of glucose and sodium bicarbonate in turn, stir and dissolve, put in ambrisentan, continue stirring to dissolve, add sodium hydroxide solution to adjust When the pH value reaches 10.0, stir evenly, make up to the full amount with a solvent, filter with a 0.22 μm filter membrane or filter element, fill it into a 2ml ampoule bottle, seal it, and obtain the product.

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Abstract

The invention provides an ambrisentan aerosol inhalation solution as well as a preparation method and application thereof. A single dose of the ambrisentan inhalation solution comprises 0.1-20mg of ambrisentan, a buffering agent, an isoosmotic adjusting agent and a solvent, and can also comprise a pH (Potential of Hydrogen) adjusting agent. The single dose specification of the inhaled solution is 1-5 ml. The dosage of the buffering agent is 0.01%-0.5%; the isoosmotic adjusting agent is added to enable the inhalation solution to have the molecular osmotic concentration by weight of 200-400 mOsmol / kg; the addition amount of the pH regulator enables the pH value of the inhalation solution to be 6.5-10.0. The ambrisentan aerosol inhalation solution is combined with the liquid atomization device, and the ambrisentan aerosol inhalation solution drug dosage form and the drug delivery system which are convenient to use, safe, effective and good in stability can be provided.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to an ambrisentan atomized inhalation solution and a preparation method thereof. Background technique [0002] Pulmonary arterial hypertension (PAH) is a kind of disease accumulation of pulmonary artery vascular endothelial cells, muscular layer and adventitia, which restricts pulmonary artery blood flow, leads to increased pulmonary vascular resistance, progressive increase of pulmonary artery pressure, and eventually causes right heart failure. A malignant cardiovascular disease with failure or even death, its main feature is the progressive increase of pulmonary vascular resistance (PVR) and pulmonary arterial pressure (PAP) caused by pulmonary artery obstruction, accompanied by irreversible pulmonary vascular remodeling, Severe symptoms of patients can cause right heart failure and death, the prognosis is poor, and the mortality rate is high. At the same time, with the inten...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K31/505A61K47/02A61K47/12A61M11/02A61P9/12
CPCA61K31/505A61K9/0078A61K9/08A61K47/02A61K47/12A61P9/12A61M11/02
Inventor 胡杰王永福都暖谷守娜
Owner INCREASEPHARM TIANJIN INST CO LTD
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