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Cisatracurium besylate composition for injection

A technology for cisatracurium besylate and injection, which is applied in the field of medicine, can solve problems such as complicated processes, and achieve the effects of good stability and excellent efficacy

Active Publication Date: 2018-01-30
亿药通(河北)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

By selecting a specific content of amino acids and polyvinylpyrrolidone, the related substances of the cisatracurium besylate freeze-dried composition are controlled at a very low level, but the process is complicated

Method used

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  • Cisatracurium besylate composition for injection
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  • Cisatracurium besylate composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032]

[0033] Preparation Process:

[0034] (1) Under the protection of nitrogen, add proper amount of water for injection to the prescription amount of cisatracurium benzenesulfonate, vitamin C, and methionine, and stir to dissolve;

[0035] (2) Under the protection of nitrogen, add 0.05% (W / V) activated carbon for needles to the mixed solution of step (1), and filter and remove the carbon after an adsorption time of 30 minutes;

[0036] (3) Under the protection of nitrogen, adjust the pH to 5.0-6.0 with citric acid, and add water for injection to the full amount;

[0037] (4) Under the protection of nitrogen, filter and sterilize the solution of step (3) with a microporous membrane;

[0038] (5) The solution is divided into sterile vials, half-pressed with rubber stoppers, placed in a freeze-drying box, lyophilized, vacuum stoppered, and capped.

Embodiment 2

[0040] prescription:

[0041]

[0042] Preparation Process:

[0043] (1) Under the protection of nitrogen, add proper amount of water for injection to the prescription amount of cisatracurium benzenesulfonate, vitamin C, and methionine, and stir to dissolve;

[0044] (2) Under the protection of nitrogen, add 0.05% (W / V) activated carbon for needles to the mixed solution of step (1), and filter and remove the carbon after an adsorption time of 30 minutes;

[0045] (3) Under the protection of nitrogen, adjust the pH to 5.0-6.0 with benzenesulfonic acid, and add water for injection to the full amount;

[0046] (4) Under the protection of nitrogen, filter and sterilize the solution of step (3) with a microporous membrane;

[0047] (5) Dispense the solution into sterile vials, semi-press rubber stoppers, put them in a freeze-drying box, freeze-dry, vacuum stoppering and capping.

Embodiment 3

[0049] prescription:

[0050]

[0051] Preparation Process:

[0052] (1) Under the protection of nitrogen, add appropriate amount of water for injection to the prescription amount of cisatracurium benzenesulfonate, vitamin C, and methionine, and stir to dissolve;

[0053] (2) Under the protection of nitrogen, add 0.05% (W / V) activated carbon for needles to the mixed solution of step (1), and filter and remove the carbon after an adsorption time of 30 minutes;

[0054] (3) Under the protection of nitrogen, adjust the pH to 5.0-6.0 with lactic acid, and add water for injection to the full amount;

[0055] (4) Under the protection of nitrogen, filter and sterilize the solution of step (3) with a microporous membrane;

[0056] (5) The solution is divided into sterile vials, half-pressed with rubber stoppers, placed in a freeze-drying box, lyophilized, vacuum stoppered, and capped.

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PUM

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Abstract

The present invention belongs to the technical field of medicine, and particularly relates to a cisatracurium besylate composition for injection, wherein the cisatracurium besylate composition comprises 2.0 mg / mL of cisatracurium besylate, 0.8-1.5 mg / mL of methionine, 1.0-2.0 mg / mL of vitamin C, an appropriate amount of a pH value adjusting agent, and 1000 mL of water for injection. According to the present invention, vitamin C provides the anti-oxidation effect, and methionine can increase the glutathione content in vivo so as to activate acetylcholinesterase, reduce the concentration of acetylcholine, and promote the combination between cisatracurium besylate and cholinergic receptors, such that the prepared pharmaceutical composition has advantages of good stability and excellent efficacy.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a cisatracurium besylate composition for injection. Background technique [0002] Cisatracurium besylate is the latest generation of muscle relaxants. Compared with the current main clinical muscle relaxant anesthetics, this product has the characteristics of metabolism through non-hepatic non-renal pathways and cardiovascular stability. The muscle relaxant effect is better than that of atracurium. The effect is 3 times stronger, without cardiovascular side effects. Cisatracurium besylate is mainly used for general anesthesia, and can be widely used in tracheal intubation, liver and kidney dysfunction, cardiovascular surgery, and elderly and pediatric patients. Since the drug was first marketed in the UK in 1996, foreign countries have gradually replaced vecuronium and atracurium, becoming the mainstream of clinical muscle relaxants. [0003] At present, clinically, cisatr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4725A61K47/22A61P23/00A61P21/02A61K31/198
Inventor 钟正明
Owner 亿药通(河北)生物科技有限公司
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