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Macitentan solution for inhalation and preparation method of macitentan solution

A macitentan and solution technology, applied in the field of medicine, can solve the problems of no macitentan, etc., and achieve the effect of good curative effect, simple operation and accurate measurement

Pending Publication Date: 2021-03-30
INCREASEPHARM TIANJIN INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no macitentan inhalation solution on the market at home and abroad

Method used

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  • Macitentan solution for inhalation and preparation method of macitentan solution
  • Macitentan solution for inhalation and preparation method of macitentan solution
  • Macitentan solution for inhalation and preparation method of macitentan solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription composition:

[0032] name composition macitentan 10.0g Tween 80 0.1g citric acid 0.03g Sodium citrate 2g Sodium chloride 8.0g Add water to 1000ml

[0033] Preparation:

[0034] Take 800ml of water for injection, control the water temperature at 45-55°C, add Tween 80 and stir to dissolve, adjust the pH to about 8.0 with citric acid-sodium citrate, add macitentan, stir to dissolve. Continue to add the prescribed amount of sodium chloride, stir to dissolve, set the volume to 1000ml, filter the resulting solution through a sterile filter, and then fill the filtered medicinal solution in a 2ml ampoule to obtain macitentan for inhalation solution.

[0035] The above solutions need to be protected from light during the production process.

Embodiment 2

[0037] Prescription composition:

[0038] name composition macitentan 8.0g Tween 80 0.08g citric acid 0.02g Sodium citrate 1.8g Sodium chloride 8.0g Add water to 1000ml

[0039] Preparation:

[0040] Take 800ml of water for injection, control the water temperature at 45-55°C, add Tween 80 and stir to dissolve, adjust the pH to about 8.0 with citric acid-sodium citrate, add macitentan, stir to dissolve. Continue to add the prescribed amount of sodium chloride, stir to dissolve, set the volume to 1000ml, filter the resulting solution through a sterile filter, and then fill the filtered medicinal solution in a 2ml ampoule to obtain macitentan for inhalation solution.

[0041] The above solutions need to be protected from light during the production process.

Embodiment 3

[0043] Prescription composition:

[0044] name composition macitentan 5.0g Tween 80 0.05g citric acid 0.02g Sodium citrate 1.2g Sodium chloride 8.0g Add water to 1000ml

[0045] Preparation:

[0046] Take 800ml of water for injection, control the water temperature at 45-55°C, add Tween 80 and stir to dissolve, adjust the pH to about 8.0 with citric acid-sodium citrate, add macitentan, stir to dissolve. Continue to add the prescribed amount of sodium chloride, stir to dissolve, set the volume to 1000ml, filter the resulting solution through a sterile filter, and then fill the filtered medicinal solution in a 2ml ampoule to obtain macitentan for inhalation solution.

[0047] The above solutions need to be protected from light during the production process.

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PUM

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Abstract

The invention relates to a macitentan solution for inhalation and a preparation method of the macitentan solution. The macitentan solution comprises an active ingredient macitentan, a stabilizer, an isoosmotic adjusting agent, a pH value adjusting agent and a solvent. The single dose specification of the macitentan solution for inhalation is 2ml, and the macitentan solution is accurate in meteringand good in curative effect; and the macitentan solution has the advantages of no preservatives, stable quality, few side reactions and the like.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a macitentan solution for inhalation 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. [0003] The current global pulmonary a...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K31/506A61K47/12A61P9/12
CPCA61K9/0078A61K31/506A61K47/12A61P9/12
Inventor 胡杰扈靖王永福
Owner INCREASEPHARM TIANJIN INST CO LTD
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