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A kind of cisatracurium besylate composition for injection

A technology of cisatracurium besylate and its composition, which is applied in the field of medicine, can solve problems such as complicated process, and achieve the effect of good stability and excellent drug effect

Active Publication Date: 2020-10-16
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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  • A kind of cisatracurium besylate composition for injection
  • A kind of cisatracurium besylate composition for injection
  • A kind of 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 an appropriate amount of water for injection to the prescription amount of cisatracurium besylate, 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), filter and remove carbon after the adsorption time is 30min;

[0036] (3) Under the protection of nitrogen, adjust the pH to 5.0-6.0 with citric acid, and replenish the 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, freeze-dried in a freeze-drying box, vacuum-pressed and capped.

Embodiment 2

[0040] prescription:

[0041]

[0042] Preparation Process:

[0043] (1) Under the protection of nitrogen, add an appropriate amount of water for injection to the prescription amount of cisatracurium besylate, 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), filter and remove carbon after the adsorption time is 30min;

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

[0046] (4) under nitrogen protection, the solution of step (3) is filtered and sterilized with a microporous membrane;

[0047] (5) The solution is divided into sterile vials, half-pressed with rubber stoppers, freeze-dried in a freeze-drying box, vacuum-pressed and capped.

Embodiment 3

[0049] prescription:

[0050]

[0051] Preparation Process:

[0052] (1) Under the protection of nitrogen, add an appropriate amount of water for injection to the prescription amount of cisatracurium besylate, 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), filter and remove carbon after the adsorption time is 30min;

[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 nitrogen protection, the solution of step (3) is filtered and sterilized with a microporous membrane;

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

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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, in particular 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 and non-kidney 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 suitable for general anesthesia, and can be widely used in endotracheal intubation, liver and kidney dysfunction, cardiovascular surgery and elderly and pediatric patients. Since the drug was first launched in the UK in 1996, it has gradually replaced vecuronium bromide and atracurium abroad and has become the mainstream of clinical muscle relaxants. [0003] At present, clinica...

Claims

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Application Information

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Patent Type & Authority Patents(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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