Preparation method of salfaprodil freeze-dried powder injection, and product and use thereof

A method for preparing salfaprodil freeze-dried powder injection, the method comprising:

• adding and dissolving salfaprodil into water to generate a solution for injection;
• filtering the solution;
• adjusting pH filtrate with an alkaline substance water solution to the value of from 8.0 to 10.0;
• adding water for injection to achieve constant volume and filling it with inert gas for protection;
• performing sterile filtration to obtain a salfaprodil solution;
• and
• freeze-drying the salfaprodil solution to obtain a salfaprodil freeze-dried powder injection,
• wherein the freeze-drying is conducted in a freeze dryer, and the method comprises pre-freezing, a temperature recovery, re-cooling, primary drying a, primary drying b, and desorption drying;
• wherein the pre-freezing comprises lowering the plate layer temperature of the freeze dryer to a temperature of −50° C. to −30° C. and keeping this temperature for 1 hour to 3 hours;
• wherein the temperature recovery comprises raising the plate layer temperature of the freeze dryer to a temperature of −5° C. to 5° C. and keeping this temperature for 1 hour to 3 hours;
• wherein the re-cooling comprises lowering the plate layer temperature of the freeze dryer to a temperature of −50° C. to −30° C. and keeping this temperature for 1 hour to 3 hours;
• wherein the primary drying a comprises raising the plate layer temperature of the freeze dryer to a temperature of −30° C. to −25° C. and keeping this temperature for 10 hours to 30 hours under a vacuum degree of 5 Pa to 20 Pa;
• wherein the primary drying b comprises raising the plate layer temperature of the freeze dryer to a temperature of 5° C. to 20° C. and keeping this temperature for 10 hours to 30 hours under a vacuum degree of 5 Pa to 20 Pa;
• and
• wherein the desorption drying comprises raising the plate layer temperature of the freeze dryer to a temperature of 10° C. to 40° C. and keeping this temperature for 10 hours to 30 hours under a vacuum degree of 5 Pa to 20 Pa.