| 摘要 |
An injection-use esomeprazole sodium lyophilized powder composition and a preparation method therefor, related to the medical field. The active ingredients of the composition are esomeprazole sodium and arginine. The specific steps for preparing the injection-use lyophilized powder are: adding into water for injection esomeprazole 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 0.1% of activated carbon and stirring for 30 minutes; filtering out the activated carbon, then filtering the medicament solution via 0.45mu and 0.22mu microporous membranes; canning the filtered medicament solution, and feeding into a lyophilizer, cooling to -40°C, thermally-insulating for two hours, then gradually warming to a temperature between -5°C and 0°C for lyophilization, and after warming to 35°C, thermally-insulating for three hours; ending the lyophilization, and removing from a container to acquire the injection-use esomeprazole sodium and arginine lyophilized powder injection. The advantages of the present invention are: convenient liquid processing, simplified aseptic operation process, increased preparation stability, obviation of the need for heat treatment for removal of water in the product, and increased rehydration (solubility) property of the preparation. |
