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

A technology of freeze-dried powder injection and glucose, which is used in drug packaging, packaging, anesthetics, etc., can solve the problems of increasing glass particles falling into local anesthetic liquid, prolonging operation time, and being unsuitable for spinal anesthesia, so as to avoid oxidative decomposition. and impurity generation, convenient extraction and use, and reasonable design of specifications

Inactive Publication Date: 2009-12-09
曾因明 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 c

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Prescription: Bupivacaine Hydrochloride 1.5g

[0016] Glucose 10g

[0017] Water for injection 300ml

[0018]

[0019] Bupivacaine-glucose freeze-dried powder injection for spinal anesthesia 100 bottles (branches)

[0020] Preparation method: Weigh 1.5g of bupivacaine hydrochloride, dissolve 10g of glucose in 300ml of water for injection, add activated carbon for adsorption, decarbonize and filter, and filter with a 0.22μm microporous membrane; the obtained filtrate is evenly divided into Vacuum freeze-drying in 100 bottles (branches) of sterile vials (or easy-to-break ampoules): ①Ultra-low temperature quick freezing and pre-freezing for 2 hours (-40℃~-60℃) to form fine crystals, ②Heat to -20℃ under vacuum ℃ constant temperature sublimation drying for 12 hours, ③heat up to 20℃ and continue vacuum drying for 12 hours; ④Use plastic aluminum cap vial sealing or cartridge sealing or easy-fold ampoule sealing t...

Embodiment 2

[0022] Prescription: Levobupivacaine Hydrochloride 1.5g

[0023] Glucose 10g

[0024] Water for injection 300ml

[0025]

[0026] Levobupivacaine-glucose freeze-dried powder injection for spinal anesthesia 100 bottles (branches)

[0027] Preparation method: Weigh 1.5g of levobupivacaine hydrochloride, dissolve 10g of glucose in 300ml of water for injection, add activated carbon for adsorption, decarbonize and filter, and filter with a 0.22μm microporous membrane; the obtained filtrate is equally packed under sterile conditions In 100 bottles (branches) of sterile vials (or cartridges or easy-to-break ampoules), vacuum freeze-drying: ①Ultra-low temperature quick freezing and pre-freezing for 2 hours (-40℃~-60℃) to form fine crystals, ②vacuum The temperature was raised to -20°C for 12 hours of constant temperature sublimation and drying, ③the temperature was raised to 20°C and vacuum drying was continued for 12 ...

Embodiment 3

[0029] Prescription: Ropivacaine Hydrochloride 1.5g

[0030] Glucose 10g

[0031] Water for injection 300ml

[0032]

[0033] Ropivacaine-glucose freeze-dried powder injection for spinal anesthesia 100 bottles (branches)

[0034] Preparation method: Weigh 1.5g of ropivacaine hydrochloride, completely dissolve 10g of glucose in 300ml of water for injection, add activated carbon for adsorption, decarbonize and filter, and filter with a 0.22μm microporous membrane; the obtained filtrate is evenly divided into Vacuum freeze-drying in 100 bottles (branches) of sterile vials (or easy-to-break ampoules): ①Ultra-low temperature quick freezing and pre-freezing for 2 hours (-40℃~-60℃) to form fine crystals, ②Heat to -20℃ under vacuum ℃ constant temperature sublimation drying for 12 hours, ③heat up to 20℃ and continue vacuum drying for 12 hours; ④Use plastic aluminum cap vial sealing or cartridge sealing or easy-fold ampoule sealing to s...

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PUM

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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 ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/445A61K31/245A61K47/26A61P23/02B65D85/00A61J1/00
Inventor 曾因明鲁显福
Owner 曾因明
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