Fudosteine Solution Preparation for Aerosol Inhalation, and Preparation Method Therefor

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.