The invention discloses a
cetrorelix acetate freeze-dried preparation and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations, the preparation method comprises the following steps: dissolving
cetrorelix acetate and then freeze-
drying; the freeze-
drying process comprises the following stages: S1, a pre-cooling stage; s2, a pre-freezing stage; s3, a sublimation
drying stage; s4, a
desorption drying stage; ice
crystal nucleation is induced in the pre-cooling stage, so that the product is completely frozen at the pre-freezing temperature, in addition, the
desorption drying temperature is increased, the water and
impurity levels of the freeze-dried product are reduced, the freeze-
drying time is shortened, and the product quality is improved. The product obtained by the technology disclosed by the invention is controllable in key quality attributes such as character, acidity, solution
clarity, related substances and the like in a storage process, and is relatively good in stability; the product freeze-drying
process time is short, the
energy consumption in the production process is reduced, and the production cost is reduced.