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Atracurium freezing-dried composition

Atracurium and composition technology are applied in the field of atracurium freeze-dried composition and preparation thereof, which can solve the problems of affecting the curative effect of medicine, easily damaged infusion solution, increase transportation cost, etc. The effect of stable storage and high human safety

Active Publication Date: 2007-12-12
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Seriously affect the efficacy of the drug
Furthermore, the infusion solution is easily damaged during transportation and increases transportation costs

Method used

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  • Atracurium freezing-dried composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Atracurium 5g

[0038] Dextran 100g

[0039] Benzenesulfonic acid adjust the pH to 3---4

[0040] Water for injection up to 2000ml

[0041] Dissolve dextran in water for injection, add about 0.05% activated carbon, dissolve, stir for 30 minutes, filter and decarbonize, add atracurium (5 g), dissolve, add an appropriate amount of benzenesulfonic acid while stirring, and adjust the pH value 3.0 to 4.0, make up water for injection, filter and sterilize with a 0.22 μm microporous membrane, divide the solution into sterile and clean vials, add butyl rubber stoppers to retain the sublimation channels, freeze-dry in a freeze-drying box, vacuum Press the plug and roll the cap to get it.

Embodiment 2

[0043] Cisatracurium 5g

[0044] Lactose 100g

[0045] Benzenesulfonic acid adjust the pH to 3---4

[0046] Water for injection up to 2000ml

[0047] Dissolve lactose in water for injection, add about 0.05% activated carbon, dissolve, stir for 30 minutes, filter and decarbonize, add cisatracurium (5 g), dissolve, add appropriate amount of benzenesulfonic acid while stirring, adjust pH value 3.0 to 4.0, make up water for injection, filter and sterilize with a 0.22 μm microporous membrane, divide the solution into sterile and clean vials, add butyl rubber stoppers to retain the sublimation channels, and freeze-dry in a freeze-drying box. Vacuum plugging and capping.

Embodiment 3

[0049] Atracurium Besylate 5g

[0050] Lactose 70g

[0051]Mannitol 30g

[0052] Benzenesulfonic acid adjust the pH to 3---4

[0053] Water for injection up to 2000ml

[0054] Dissolve lactose and mannitol in water for injection, add about 0.05% activated carbon, dissolve, stir for 30 minutes, filter and decarbonize, add atracurium benzenesulfonate (5 g), dissolve, add benzenesulfonic acid while stirring Appropriate amount, adjust the pH value from 3.0 to 4.0, make up water for injection, filter and sterilize with a 0.22 μm microporous membrane, divide the solution into sterile and clean vials, add butyl rubber stoppers to retain the sublimation channel, and freeze-dry Freeze-dry in the box, vacuum stopper and cover.

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PUM

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Abstract

The invention discloses freeze drying composition of atracurium. The composition adopts atracurium or its pharmaceutically acceptable salt or optical isomer as active ingredient, and also comprises sugar and organic acid. The invention also discloses a method for preparing the composition. The inventive composition has good water-solubility and good storing stability, low stimulation to blood vessel, and high safety; is suitable for clinical application.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a freeze-dried composition of atracurium and its preparation method and application. Background technique [0002] UK 1 579822, US4 1 79507, WO92 / 00965 and Eur.J.Med.Chem-Chem, Ther.1984-19, No.5, P441-450 and other documents have recorded atracurium besylate (I) (Chemical name: 2,2'-(3,11-dioxo-4,10-dioxa-1,13-tridecylene)bis[6,7-dimethoxy-1-( 3,4-dimethoxybenzyl)-2-methyl-1,2,3,4-tetrahydroisoquinoline [(2)]dibenzenesulfonate, common name is atracuriumbesylate) and cis-atratrobesylate besylate Cucuronium (II) (chemical name: [1 R-[1 α, 2α (1R * , 2R * )]]-2,2'-(1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]bis[1-(3,4-dimethoxyphenyl) Methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinoline] dibenzenesulfonate, common name is Cisatracurium besylate) and its preparation method. [0003] [0004] Atracurium (especially cisatracurium) is mainly degraded by Hofrnann clear...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/472A61K9/19A61K47/26A61K47/36A61P21/02
Inventor 黄乐群王磊宋格胜杜云刘胤许小兵
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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