Lumbar anesthesia special local anaesthetic-glucose lyophilized powder injection as well as preparation method and package method thereof

Abstract

The invention discloses a lumbar anesthesia special local anaesthetic-glucose lyophilized powder injection as well as a preparation method and a package method thereof. Corresponding local anaesthetic-glucose is dissolved into water for injection, activated carbon is added for adsorption, then decarburizing filtration and 0.22 mum microporous membrane filtration are carried out, the obtained filtrate is bottled in an aseptic sirin bottle or a pliable ampoule under aseptic condition according to specification, and lyophilized powder is obtained after vacuum freezing and drying; then, plastic aluminium cap sirin bottle seal or portable bottle seal or pliable ampoule process is used for sealing the ampoule which is then marked to obtain the aseptic lumbar anesthesia special local anaesthetic-glucose lyophilized powder injection; the lyophilized powder injection and corresponding solvent adopt pre-filling and sealing injector technology to package and then the lyophilized powder injection and corresponding solvent are sterilized and outer packaged to be a lumbar anesthesia drug utilization unit. The invention is characterized in that the workload of an anaesthetist is reduced to the greatest extent, and the occurrence of accidents of pumping drug errors as well as the oxidation decomposition under high temperature and high pressure and the generation of impurities are avoided.

Description

technical field [0001] A preparation method and packaging process of a special local anesthetic for spinal anesthesia-glucose freeze-dried powder injection. It is characterized in that it provides a kind of four commonly used local anesthetics-glucose freeze-dried powder injection containing spinal anesthesia dosage (bupivacaine-glucose for spinal anesthesia, levobupivacaine-glucose, ropivacaine-glucose, etc.) or tetracaine-glucose freeze-dried powder injection, the preparation method of vial or easy-fold ampoule packaging); the solvent is water for injection 3ml (vial or cartridge or easy-fold ampoule packaging); and adopt sterilized outer packaging into a Spinal anesthesia unit. The freeze-dried powder injection and the corresponding solvent can also be packaged in a pre-filled syringe and then sterilized and packaged into a spinal anesthesia unit for use in clinical spinal anesthesia or combined spinal-epidural anesthesia. Background technique [0002] The neurological ...

AI Technical Summary

Problems solved by technology

At present, domestic marketed local anesthetic injections have the following defects: ① The stability of the injection formulation is relatively poor

②The outer packaging of injection ampoules is not designed with aseptic packaging, and it is inconvenient to aseptically draw medicine during the implementation of spinal anesthesia

③The defect of non-breakable ampoules is that the possibility of glass particles falling into the local anesthetic solution increases when the sand wheel is sawed and opened

④The minimum packaging dose of commercially available local anesthetics is not suitable for spinal anesthesia, and all of them need to be extracted and added with diluent, which prolongs the operation time and increases the chance of infection

These drugs are relatively cumbersome to draw before use; and sometimes the vasoconstrictor effect after adding the vasoconstrictor drug adrenaline or ephedrine to the local anesthetic solution has a potential hidden danger of anterior spinal artery ischemia, which increases the spinal neurotoxicity of the local anesthetic