The invention discloses an
omeprazole sodium freeze-dried
powder injection and a preparation method thereof. The
omeprazole sodium freeze-dried
powder injection contains an
active ingredient, namely,
omeprazole sodium monohydrate, and auxiliary materials, namely,
calcium disodium edetate and
sodium hydroxide. The preparation method of the
omeprazole sodium freeze-dried
powder injection is characterized by comprising the following steps: weighing the
calcium disodium edetate of prescription amount and dissolving the
calcium disodium edetate in water for injection, stirring, dissolving, and regulating pH value to 10.0-12.0 by using 10% of
sodium hydroxide solution; weighing
omeprazole sodium of the prescription amount and adding the
omeprazole sodium in the mixture, stirring at
room temperature for
dissolution, supplementing and adding the water for injection to full amount; adding
active carbon, stirring at
room temperature for decoloration and
endotoxin removal, conducting rough
filtration to remove carbon firstly, and then conducting refining
filtration by using a filter membrane of 0.22 Mum; taking refining filtrate to test intermediate, conducting encapsulation after meeting requirements; and freeze-
drying and unboxing, thus obtaining the omeprazole sodium freeze-dried
powder injection. The freeze-
drying technology of the omeprazole sodium freeze-dried
powder injection takes temperature below minus 40 DEG C as pre-freezing temperature; after pre-freezing for at least two hours, sublimation is started, wherein the sublimation temperature is 5-12 DEG C, the sublimation time is over 14 hours; and then
drying is conducted for over 2 hours at the temperature of 20-35 DEG C. Unboxing is carried out after a stopper is added and a cover is put in place, thus obtaining the finished product of the omeprazole sodium freeze-dried
powder injection.