This invention belongs to the field of
pharmaceutical formulation technology, specifically relating to an injectable
ertapenem sodium suitable for pediatric dosage and its preparation method. Each
vial contains 500 mg of
ertapenem, and the injectable
ertapenem sodium is prepared by lyophilization of the following components: 500 mg-530 mg ertapenem
sodium; 150-300 mg
mannitol; 100-180 mg
trehalose dihydrate; 45-60 mg
sodium bicarbonate; pH adjusted to 6.8-8.0 with
sodium hydroxide; and water for injection added to a filling volume of 2.5 mL per
vial. This invention provides a pediatric-specific specification, making clinical use more convenient, while also exhibiting excellent stability and suitability for industrial production.