Dexmedetomidine hydrochloride injection and preparation process thereof

A technology of dexmedetomidine hydrochloride and injection, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, organic active ingredients, etc., and can solve the problem of accelerated foreign matter, increased foreign matter, and increased visible foreign matter in drugs, etc. problem, to achieve the effect of low cost, stable quality, and convenient industrial production

Active Publication Date: 2015-12-23
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, although its curative effect is remarkable and its sales volume is very large, the domestic market is currently vacant, but because the drug itself is easily affected by light and metal ions, there are problems such as increased visible foreign matter.
Therefore, during the stability inspection, the increase of visible foreign matter in the accelerated 6-month and long-term 9-month samples has not been resolved.

Method used

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  • Dexmedetomidine hydrochloride injection and preparation process thereof
  • Dexmedetomidine hydrochloride injection and preparation process thereof
  • Dexmedetomidine hydrochloride injection and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0015] Raw materials: 0.2g of dexmedetomidine hydrochloride (calculated as dexmedetomidine), 18g of sodium chloride, 0.08g of sodium tartrate, add water for injection to 2000ml, and make 1000 sticks.

[0016] Preparation method: 1) take 95% of the prescription amount of water for injection, boil it and lower the temperature to 60°C; 2) turn on the stirrer, add the prescription amount of sodium chloride, stir for 5 minutes to dissolve it; add dexmedetomidine hydrochloride , stir for 10 minutes to make it completely dissolve and mix evenly; 3) then cool down to 30°C, add the prescribed amount of sodium tartrate, stir to make it completely dissolved, add active carbon with a main material amount of 3% (w / w) and stir for 15 minutes ; 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 and a 0.22 μm microporous filter, take a sample at the sampling port to detect the content and pH of the liquid medicine, an...

Embodiment 2

[0018] Raw materials: dexmedetomidine hydrochloride (calculated as dexmedetomidine) 0.2g, sodium chloride 18g, edetate calcium sodium 0.08g, dihydroconiferyl alcohol γ-O-α-L-rhamnoside 0.02 g, add water for injection to 2000ml, and make 1000 sticks.

[0019] Preparation method: 1) take water for injection with 95% of the prescription amount, boil it and lower the temperature to 70°C; 2) turn on the stirrer, add the prescription amount of sodium chloride, stir for 5 minutes to dissolve it; add dexmedetomidine hydrochloride , stirred for 10 minutes to completely dissolve and mix evenly; 3) then lower the temperature to 50°C, add the prescribed amount of calcium sodium edetate and dihydroconiferyl alcohol γ-O-α-L-rhamnoside, and stir to make it Completely dissolve, add activated carbon with 3% (w / w) main ingredient, stir and adsorb for 15 minutes; 4) add water for injection to the full amount, continue to stir and circulate for 15 minutes, and filter with 0.5μm titanium rod and 0...

Embodiment 3

[0021] Raw materials: dexmedetomidine hydrochloride (calculated as dexmedetomidine) 0.2g, sodium chloride 18g, edetate calcium sodium 0.08g, add water for injection to 2000ml, and make 1000 sticks.

[0022] Preparation method: 1) take water for injection with 95% of the prescription amount, boil it and lower the temperature to 70°C; 2) turn on the stirrer, add the prescription amount of sodium chloride, stir for 5 minutes to dissolve it; add dexmedetomidine hydrochloride , stir for 10 minutes to make it completely dissolve and mix evenly; 3) then cool down to 50°C, add the prescribed amount of edetate calcium sodium, stir to make it completely dissolve, add 3% (w / w) of active carbon as the main ingredient and stir Adsorb for 15 minutes; 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 and a 0.22 μm microporous filter, take a sample at the sampling port to detect the content and pH value of the drug s...

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Abstract

The invention belongs to the technical field of drug preparation, and particularly relates to dexmedetomidine hydrochloride injection and a preparation process thereof. The dexmedetomidine hydrochloride injection comprises main materials and water for injection. The main materials comprise an active component and auxiliary materials. The auxiliary materials comprise an osmotic pressure modifier and a metal ion complexing agent. Dexmedetomidine hydrochloride serves as the active component. Sodium chloride serves as the osmotic pressure modifier. Compared with the prior art, the dexmedetomidine hydrochloride injection has the advantages that pH, content and related substance results of all embodiments are still qualified after the dexmedetomidine hydrochloride injection is subjected to high temperature, illumination and acceleration for 6 months and 24 months, and it is proved that the whole product is stable in quality. In addition, the dexmedetomidine hydrochloride injection is simple in preparation process, low in cost and beneficial to 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 and a preparation process thereof. Background technique [0002] Dexmedetomidine hydrochloride is a highly efficient and highly selective alpha 2 - Adrenergic receptor agonist, which was first jointly developed by OrionPharma Company of Finland and Abott Company of the United States. The drug has anti-sympathetic, analgesic and sedative effects by acting on two adrenergic receptors, and is the effect of clonidine8 times. FDA approved it as a short-term (<24 hours) sedative and analgesic drug in intensive care, especially in the early postoperative period. It acts on two adrenergic receptors by activating the presynaptic alpha 2 -receptors, inhibiting the release of norepinephrine and stopping the transmission of pain signals; in addition, by activating post-synaptic membrane receptors, dexmedetomidine inhibi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4174A61K47/02A61K47/18A61P25/20A61P29/00
Inventor 吴荣翠卢秀莲杜振新姜瑞玲董娟王绍同
Owner CISEN PHARMA
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