The invention relates to the technical field of pharmaceutical preparations, and discloses a
formoterol fumarate
inhalation solution and a preparation method thereof. The
formoterol fumarate
inhalation solution provided by the invention is prepared from the following components in
mass concentration: 0.05 percent to 0.2 percent of
sodium hydroxide, 0.6 percent to 1.0 percent of
tartaric acid, 0.1 percent to 0.3 percent of
aminocaproic acid, 0.001 percent to 0.1 percent of
polysorbate 20, 0.0009 percent to 0.0011 percent of
formoterol fumarate, 0.7 percent to 0.9 percent of
sodium chloride and the balance of water for injection. By adjusting the pH value of the solution, adding the
polysorbate 20 and the
aminocaproic acid, controlling the raw materials and the dissolving temperature thereof, filling
nitrogen in the dissolving process and the filling process, and combining
filtration and sterilization, the invention provides a method for improving the stability of the product under the condition of controlling the
impurity level of the product. And the preparation method can be used for industrially producing the formoterol fumarate
inhalation solution.