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Dexmedetomidine hydrochloride injection composition

A technology of dexmedetomidine hydrochloride and injection, which is applied in the field of drug preparation to achieve the effects of convenient industrial production, better curative effect and simple process

Active Publication Date: 2017-12-01
广东泽盛药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using metal ion complexing agents to improve the stability of injections, but this method can only deal with the stability problems caused by metal ions

Method used

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  • Dexmedetomidine hydrochloride injection composition
  • Dexmedetomidine hydrochloride injection composition
  • Dexmedetomidine hydrochloride injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041]

[0042] Preparation:

[0043] (1) Take water for injection of 80% of the prescription amount, the temperature is 30-40°C, and degassing for 30min;

[0044] (2) Add the prescribed amount of sodium chloride and dexmedetomidine hydrochloride, stir for 10 minutes to dissolve, then add the prescribed amount of reduced glutathione and stir to dissolve.

[0045] (3) Add 0.06% (W / V) activated carbon for needles, stir and adsorb for 30 minutes;

[0046] (4) Add water for injection to the full amount, continue to stir and circulate for 15 minutes, filter with a 0.5 μm titanium rod to remove carbon, degas for 90 minutes, pass nitrogen gas for 20 minutes, then pass through a 0.45 μm microporous filter for fine filtration, and take samples for intermediate detection ;

[0047] (5) After passing the test, fill through two-stage 0.22μm microporous filters, fill the colorless and transparent ampoule filled with injection liquid with high-purity nitrogen, melt seal, sterilize at 1...

Embodiment 2-8

[0049]

[0050]

[0051] Preparation method: all with embodiment 1

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Abstract

The invention belongs to the technical field of medicines and particularly relates to a dexmedetomidine hydrochloride injection composition which includes: dexmedetomidine hydrochloride, reduced glutathione, sodium chloride and water for injection, wherein the mass ratio of the dexmedetomidine hydrochloride to the reduced glutathione in the injection composition is 0.6:1-4:1. Compared with the prior art, the dexmedetomidine hydrochloride injection composition has good photo-stability, is not liable to generate visible foreign matters, is easy to store for long time and is safe to use clinically, has good treatment effect and is low in side effect. In addition, a preparation process of the dexmedetomidine hydrochloride injection composition is simple and low-cost and has convenience in industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a dexmedetomidine hydrochloride injection composition. Background technique [0002] Dexmedetomidine hydrochloride is a highly efficient and highly selective α2-adrenoceptor agonist, its chemical name is: (+)-4-(S)-[1-(2,3-dimethyl Phenyl)ethyl]-1H-imidazole hydrochloride, has antisympathetic, analgesic and sedative effects by acting on two adrenergic receptors, is an easily arousable sedative, can provide sedation and can wake up at any time , There is almost no respiratory depression, and it also has a certain neuroprotective effect. Dexmedetomidine hydrochloride is the dextroisomer of the α2-adrenergic receptor agonist medetomidine. Compared with medetomidine, it has stronger selectivity for central α2-adrenoceptor stimulation, and With a short half-life and a small dosage, it is clinically suitable for the sedation of intubated and ventilated patien...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4174A61K38/06A61K47/18A61P25/20A61K47/02
CPCA61K9/0019A61K9/08A61K31/4174A61K38/06A61K47/02A61K47/183A61K2300/00
Inventor 钟正明
Owner 广东泽盛药业有限公司
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