Ropivacaine freeze-dried powder and injection preparation in use for injection and preparation method

Abstract

A freeze-dried injection of ropivacaine is prepared from the ropivacaine methanesulfonate (or hydrochloride), diluent chosen from mannitol, lactose, sodium chloride, dextran, glucose, glycine, hydrolytic gelatin and povidone, isotonic regulator and pH regulator through dissolving them in the water for injection, stirring, cooling, adding the water for injection, adding activated carbon, adsorption, filtering for removing carbon, fitlering by millipore filter and freeze drying.

Description

technical field

[0001] The invention relates to a pharmaceutical preparation, in particular to a ropivacaine freeze-dried powder injection and a preparation method. Background technique

[0002] Ropivacaine (ropivacaine) is a new type of long-acting amide local anesthetic listed by Astra Pharmaceuticals in 1996. In December 1998, ropivacaine hydrochloride injection was imported into China. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction, so no need to add epinephrine, and it has no obvious effect on uterine placental blood flow. Low concentrations of ropivacaine can effectively block sensory nerve transmission and have little effect on motor nerves. Therefore, this drug is especially suitable for postoperative analgesia and obstetric anesthesia. Judging from the clinical application of ropivacaine in recent years at home and abroad, newborns have good tolerance to this drug, and the motor ...