Beijing Increase Innovation Drug Research Co.; LTD
发明人:
Baoxian Zhang,Jie Hu
申请号：
US16904117
公开号：
US20200316003A1
申请日:
2020.06.17
申请国别(地区):
US
年份:
2020
代理人:
摘要：
Disclosed are a fudosteine solution preparation for aerosol inhalation, and a preparation method therefor. The fudosteine solution preparation for aerosol inhalation comprises fudosteine, salts thereof and/or hydrates thereof； a metal complexing agent； and water for injection. The method for preparing the fudosteine solution preparation for aerosol inhalation includes the following steps: adding water for injection to a liquid formulation device and filling in nitrogen for protection, keeping the nitrogen in a liquid formulation tank at a positive pressure, and determining a residual oxygen content to be less than 2 mg/L； weighing the metal complexing agent, and stirring until the same dissolves； adding fudosteine, salts thereof and/or hydrates thereof, and stirring until the same dissolves； adding a pH adjusting agent, and determining the residual oxygen content to be less than 2 mg/L； supplementing with water for injection to a full amount, and stirring until evenly mixed； and carrying out fine filtration under sterile conditions, encapsulating and filling in nitrogen.
