Cisatracurium besylate injection and preparation method thereof

A technology of cisatracurium besylate and injection, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve the harsh and safe conditions of production, transportation and clinical application. Sex can not be guaranteed and other problems, to achieve the effect of good compliance and high safety

Inactive Publication Date: 2021-02-02
南京斯泰尔医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The inventor found that the existing technology can guarantee the stability of the product to a certain extent, but the production, transportation and clinical application conditions are relatively harsh, the safety cannot be guaranteed, and there is a great risk in clinical use

Method used

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  • Cisatracurium besylate injection and preparation method thereof
  • Cisatracurium besylate injection and preparation method thereof
  • Cisatracurium besylate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]

[0034] Preparation Process:

[0035] (1) Add ethanol to 800ml water for injection at 30°C, stir and mix evenly;

[0036] (2) Add citric acid and stir for 5 minutes to dissolve, then add cisatracurium besylate and stir for 5 minutes to dissolve; measure pH 4.51;

[0037] (3) constant volume. Dilute to 1000ml with water for injection;

[0038] (4) Sterile filtration. The liquid medicine is filtered through a 0.45 μm coarse filter and a 0.22 μm fine filter.

[0039] (5) Ampoule filling, light inspection, and packaging.

Embodiment 2

[0041]

[0042] Preparation Process:

[0043] (1) Add ethanol to 800ml water for injection at 30°C, stir and mix evenly;

[0044] (2) Add citric acid and stir for 5 minutes to dissolve, then add cisatracurium besylate and stir for 5 minutes to dissolve; measure pH3.32;

[0045] (3) constant volume. Dilute to 1000ml with water for injection;

[0046] (4) Sterile filtration. The liquid medicine is filtered through a 0.45 μm coarse filter and a 0.22 μm fine filter.

[0047] (5) Ampoule filling, light inspection, and packaging.

Embodiment 3

[0049]

[0050] Preparation Process:

[0051] (1) Add ethanol to 800ml water for injection at 30°C, stir and mix evenly;

[0052](2) Add citric acid and stir for 5 minutes to dissolve, then add cisatracurium besylate and stir for 5 minutes to dissolve; measure pH 3.01;

[0053] (3) constant volume. Dilute to 1000ml with water for injection;

[0054] (4) Sterile filtration. The liquid medicine is filtered through a 0.45 μm coarse filter and a 0.22 μm fine filter.

[0055] (5) Ampoule filling, light inspection, and packaging.

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PUM

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Abstract

The invention discloses cisatracurium besylate injection and a preparation method thereof. The cisatracurium besylate injection can be subjected to constant-temptation fluid preparation and storage, also can be applied in a clinical compatibility way, is high in safety, is high in medicine compliance and provides a new choice for clinical application. The injection consists of cisatracurium besylate, citric acid and ethyl alcohol, is safe and stable, and has the advantages of a moderate fluid preparation technology and storage condition and good clinical compliance.

Description

technical field [0001] The invention relates to a skeletal muscle relaxant, in particular to a cisatracurium besylate injection preparation capable of liquid preparation and storage at room temperature and a preparation method thereof. Background technique [0002] Cisatracurium besylate is a neuromuscular blocking agent with moderate onset / duration, which can be used clinically as an adjunct to general anesthesia or intensive care unit (ICU) sedation to relax skeletal muscles, facilitate endotracheal intubation, and assist ICU artificial respiration of the patient. [0003] Cisatracurium besylate is the all-cis isomer among the 10 isomers of atracurium besylate. Compared with atracurium besylate, cis atracurium besylate has a large Advantages, the drug effect is about 3 times that of atracurium besylate, no obvious release of histamine, small muscle relaxant effect, no accumulation effect, and small cardiovascular response, no dependence on liver, kidney and other organ fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/12A61K47/10A61K31/4725A61P23/00A61P25/20
CPCA61K9/0019A61K9/08A61K47/12A61K47/10A61K31/4725A61P23/00A61P25/20
Inventor 孙军娣唐晶晶
Owner 南京斯泰尔医药科技有限公司
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