Long-acting lyophilized powder injection preparation of cisatracurium besilate

A technology of cisatracurium besylate and freeze-dried powder injection, which is applied in the field of chemical pharmacy, can solve the problems of poor stability and short duration of cisatracurium besylate, achieve quality control, convenient operation, and improve Effect of Storage Stability and Release Time

Inactive Publication Date: 2017-05-31
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cisatracurium besylate has poor stability in aqueous solution, and the duration is short, which limits the clinical application of cisatracurium besylate to a certain extent.

Method used

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  • Long-acting lyophilized powder injection preparation of cisatracurium besilate
  • Long-acting lyophilized powder injection preparation of cisatracurium besilate
  • Long-acting lyophilized powder injection preparation of cisatracurium besilate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] (1) take by weighing recipe quantity polyethylene glycol-phosphatidylethanolamine, soybean lecithin, sodium deoxycholate, sodium thiosulfate, vitamin E, polyvinylpyrrolidone and dissolve in ethanol, mix uniformly, form liposome solution, The liposome solution was placed on a thin film evaporator, and ethanol was removed under reduced pressure to obtain a lipid film.

[0030] (2) Configure a phosphate buffer solution with a pH of 3.5, add the buffer solution to the lipid film prepared in step (1), and after the lipid film is fully hydrated, prepare blank liposomes with a homogenizer for subsequent use ;

[0031] (3) Weigh cisatracurium besylate, be dissolved in water for injection, filter and sterilize through a microporous membrane, join in the blank liposome prepared in step (2), then add sodium chloride , mannitol and glucose, mixed evenly, left for 10-30 minutes, then sterilized by microporous membrane filtration, filled in vials, and freeze-dried to obt...

Embodiment 2

[0033]

[0034] (1) take by weighing recipe quantity polyethylene glycol-phosphatidylethanolamine, soybean lecithin, sodium deoxycholate, sodium thiosulfate, vitamin E, polyvinylpyrrolidone and dissolve in ethanol, mix uniformly, form liposome solution, The liposome solution was placed on a thin film evaporator, and ethanol was removed under reduced pressure to obtain a lipid film.

[0035] (2) Configure a phosphate buffer solution with a pH of 3.8, add the buffer solution to the lipid film prepared in step (1), after the lipid film is fully hydrated, prepare blank liposomes with a homogenizer, and set aside ;

[0036] (3) Weigh cisatracurium besylate, be dissolved in water for injection, filter and sterilize through a microporous membrane, join in the blank liposome prepared in step (2), then add sodium chloride , mannitol and glucose, mixed evenly, left for 10-30 minutes, then sterilized by microporous membrane filtration, filled in vials, and freeze-dried to obtain the ...

Embodiment 3

[0038]

[0039]

[0040] (1) take by weighing recipe quantity polyethylene glycol-phosphatidylethanolamine, soybean lecithin, sodium deoxycholate, sodium thiosulfate, vitamin E, polyvinylpyrrolidone and dissolve in ethanol, mix uniformly, form liposome solution, The liposome solution was placed on a thin film evaporator, and ethanol was removed under reduced pressure to obtain a lipid film.

[0041] (2) Configure a phosphate buffer solution with a pH of 4.0, add the buffer solution to the lipid film prepared in step (1), after the lipid film is fully hydrated, prepare blank liposomes with a homogenizer, and set aside ;

[0042] (3) Weigh cisatracurium besylate, be dissolved in water for injection, filter and sterilize through a microporous membrane, join in the blank liposome prepared in step (2), then add sodium chloride , mannitol and glucose, mixed evenly, left for 10-30 minutes, then sterilized by microporous membrane filtration, filled in vials, and freeze-dried to...

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PUM

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Abstract

The invention relates to a long-acting lyophilized powder injection preparation of cisatracurium besilate. The long-acting lyophilized powder injection preparation of the cisatracurium besilate is prepared from the following components in parts by weight: 3-10 parts of cisatracurium besilate, 10-40 parts of polyethylene glycol-phosphatidyl ethanolamine, 10-30 parts of soya bean lecithin, 5-15 parts of sodium deoxycholate, 0.15-0.50 part of an antioxidant, 0.5-1 part of polyvinylpyrrolidone and 5-25 parts of a frozen-dried supporting agent. The preparation can be used for intravenous administration, the problem of the mass stability is effectively solved, the pharmacodynamic action time and the bioavailability of the preparation are improved, and meanwhile, the toxic or side effect is also relatively reduced.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a cisatracurium besylate composition for injection and a preparation method thereof, in particular to a long-acting freeze-dried powder injection of cisatracurium besylate 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 musc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/127A61K31/4725A61K47/32A61K47/22A61K47/02A61P21/02A61P23/00
CPCA61K31/4725A61K9/0019A61K9/127A61K9/19A61K47/02A61K47/22A61K47/32
Inventor 张耀华姜允菊刘峰峰刘亮亮曹锡锋
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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