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Cisatracurium besilate composition for injection and preparation method and application thereof

A technology of cisatracurium besylate and cisatracurium, which is applied in the field of cisatracurium besylate for injection and its preparation, can solve the problems of limited development and achieve convenient operation, simple composition, Low product-related substances and good reproducibility

Active Publication Date: 2015-03-25
HAINAN XIANTONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this way, the development of cisatracurium besylate powder injection products for injection has good prospects for solving many problems existing in existing atracurium injections, but how to solve the stability and clarity problems of powder injection products , has also become an important issue restricting its development

Method used

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  • Cisatracurium besilate composition for injection and preparation method and application thereof
  • Cisatracurium besilate composition for injection and preparation method and application thereof
  • Cisatracurium besilate composition for injection and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0144]

[0145] 【Preparation】

[0146] Take cisatracurium besylate and add 50% of the total amount of water for injection at 30°C, stir to dissolve, add activated carbon for needles with a volume of 0.05% of the liquid medicine, stir for 15 minutes, filter and decarbonize, and obtain the liquid medicine.

[0147] Add sodium chloride and glucose into 25% of the total amount of water for injection at 30° C., stir and dissolve to obtain an excipient solution.

[0148] Mix the medicinal solution and the auxiliary material solution, add 7% hydrochloric acid solution to adjust the pH value of the solution to 2.2, add water for injection to the full amount, and add 7% hydrochloric acid solution to adjust the pH value to 2.3.

[0149] After passing the intermediate inspection, use 0.22μm filter material to sterilize and filter, quantitatively fill in 7ml vials (theoretical loading is 0.5ml), press the rubber stopper halfway, put it in a freeze-drying box, and open the circulation p...

Embodiment 2

[0151]

[0152] 【Preparation】

[0153] Add cisatracurium besylate to 50% of the total amount of water for injection at 40°C, stir to dissolve, add activated carbon for needles with a volume of 0.05% of the liquid medicine, stir for 15 minutes, filter and decarbonize, and obtain the liquid medicine.

[0154] Add 25% of the total amount of sodium chloride and glucose into water for injection at 40° C., stir and dissolve to obtain an excipient solution.

[0155] The medicinal solution is mixed with the auxiliary material solution, and the pH value is adjusted to 2.5 by adding 10% citric acid solution, and the water for injection is added to the full amount, and the pH value is adjusted to 2.5 by adding 10% citric acid solution.

[0156] After passing the intermediate inspection, use 0.22μm filter material to sterilize and filter, quantitatively fill in 7ml vials (theoretical loading is 1ml), press the rubber stopper halfway, put it in a freeze-drying box, and turn on the circu...

Embodiment 3

[0158]

[0159] 【Preparation】

[0160] Add cisatracurium besylate to 50% of the total amount of water for injection at 50°C, stir to dissolve, add activated carbon for needles with a volume of 0.05% of the liquid medicine, stir for 15 minutes, filter and decarbonize, and obtain the liquid medicine.

[0161] Add 25% of the total amount of sodium chloride and glucose into water for injection at 50° C., stir and dissolve to obtain an excipient solution.

[0162] The medicinal solution is mixed with the auxiliary material solution, 7% lactic acid solution is added to adjust the pH value to 2.8, water for injection is added to the full amount, and 7% lactic acid solution is added to adjust the pH value to 3.0.

[0163] After passing the intermediate inspection, use 0.22μm filter material to sterilize and filter, quantitatively fill in 7ml vials (theoretical loading is 2ml), half-press the rubber stopper, put it in a freeze-drying box, and turn on the circulation pump for shelf c...

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PUM

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Abstract

The invention belongs to the field of chemical pharmacy and in particular relates to a cisatracurium besilate composition for injection and a preparation method and application thereof. The cisatracurium besilate composition for injection comprises cisatracurium besilate, sodium chloride, glucose and a pH regulator, wherein cisatracurium besilate takes cisatracurium as an active ingredient, and cisatracurium, sodium chloride and glucose are combined according to a certain ratio. The cisatracurium besilate composition for injection disclosed by the invention is simple in composition, convenient to operate, simple in freeze-drying process, controllable in quality, low in content of product related substances, high in reproducibility and convenient to popularize and utilize.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a composition of cisatracurium besylate for injection and a preparation method thereof. Background technique [0002] Cisatracurium besilate (cisatracurium besilate) is a new type of benzylisoquinoline intermediate-effect non-depolarizing muscle relaxant, one of the ten isomers of atracurium, and the latest generation of muscle relaxant , has similar muscle relaxant effect and metabolic process as atracurium besylate. Cisatracurium besylate has the characteristics of metabolism through non-hepatic and non-kidney pathways and cardiovascular stability. The muscle relaxation effect is 3 times stronger than that of atracurium, and does not release histamine, and the cardiovascular reaction is small. It is more ideal A medium-acting non-depolarizing muscle relaxant. Compared with the current main clinical muscle relaxant anesthetics, cisatracurium besilate is mainly suit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4725A61K47/26A61K47/04A61P21/02A61P23/00
Inventor 齐慧
Owner HAINAN XIANTONG PHARMA CO LTD
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