| abstract |
The invention discloses a glycerin fructose sodium chloride injection and a preparation method thereof, wherein the formula comprises the following components in percentage by weight/volume: 10% of glycerol, 5% of fructose, 0.9% of sodium chloride and 0.1-0.5% of polyethylene glycol-distearoyl phosphatidyl ethanolamine. The invention solves the problem that the glycerol fructose sodium chloride injection cannot tolerate the sterilization of an over-sterilization method (F0 is more than or equal to 12). By only adding polyethylene glycol-distearoyl phosphatidyl ethanolamine as an auxiliary material, the fructose and the pH value are stabilized in the high-temperature steam sterilization process, the problem that the related substance 5-HMF exceeds the standard when the glycerol fructose sodium chloride injection is stored and placed for a long time is solved, and the safety of the glycerol fructose sodium chloride injection as a clinical medicament is greatly improved. |