HAINAN WEI-KANG PHARMACEUTICAL (QIANSHAN) COMPANY LIMITED;海南卫康制药（潜山）有限公司
发明人:
WANG, Liuyi,汪六一,WANG, Jincan,汪金灿,LI, Zuhong,李祖红
申请号：
CNCN2013/072101
公开号：
WO2013/177963A1
申请日:
2013.03.04
申请国别(地区):
CN
年份:
2013
代理人:
摘要：
An injection-use pantoprazole sodium lyophilized powder composition and a preparation method therefor, related to the medical field. The active ingredients of the composition are: pantoprazole sodium, citrulline, L-arginine, and adenosine triphosphate. The specific steps for preparing the lyophilized powder composition are: adding into water for injection pantoprazole sodium of a composition ratio between 0.1% and 99.9%, citrulline of a composition ratio between 99.9% and 0.1%, L-arginine of a composition ratio between 99.9% and 0.1%, adenosine triphosphate of a composition ratio 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 and stirring for 30 minutes； filtering out the activated carbon, then filtering the medicament solution via 0.45μm and 0.22μm microporous membranes； canning 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, then warming to 35°C, and thermally insulating for three hours； ending the lyophilization, and removing from a container. 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 the removal of water in the product, and increased rehydration (solubility) property of the preparation.La présente invention concerne une composition de poudre lyophilisée de pantoprazole sodique pour injection et un procédé de préparation associé, en relation avec le domaine médical. Les principes actifs de la composition sont : le pantoprazole sodique, la citrulline, la L-arginine, et le triphosphate d'adénosine. Les étapes spécifiques de préparation de la composition de poudre lyophilisée sont : ajout dans l'eau pour injection de pantoprazole sodique en un rap
