| 摘要 |
An injection-use levorotatory-pantoprazole sodium lyophilized powder composition and a preparation method therefor. The active ingredients of the composition are: levorotatory-pantoprazole sodium and arginine. The specific steps for preparing the lyophilized powder composition are: adding into water for injection levorotatory-pantoprazole sodium of a mass percent between 0.1% and 99.9%, arginine of a mass percent between 99.9% and 0.1%, and mannitol that is 5 to 10 times the amount of the active ingredients; dissolving by stirring, then adding an NaOH solution to adjust the pH value to 11.0; adding activated carbon of 0.1% of the total volume and stirring for 30 minutes; filtering out the activated carbon, then filtering the medicament solution via 0.45mu and 0.22mu microporous membranes; canning and feeding into a lyophilizer; cooling to -40°C, thermally-insulating for two hours, gradually warming to a temperature between -5°C and 0°C for lyophilization, then after warming to 35°C, thermally-insulating for three hours; ending the lyophilization, and removing from a container to acquire the injection-use levorotatory-pantoprazole sodium lyophilized powder composition. |
