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Cisatracurium besylate lyophilized preparation composition stable at room temperature and preparation method thereof

A technology for cisatracurium besylate and freeze-dried preparations, which is applied in the field of cisatracurium besylate freeze-dried preparations and its preparation, and can solve the problem of increased production costs, unfavorable storage for hospitals and patients, etc. problems, to achieve the effect of facilitating production, storage and carrying, and improving stability

Inactive Publication Date: 2013-05-01
CUREGEN JIANGSU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is required in the instructions of the marketed products to be stored at 2-8°C, and the validity period is two years. Storage under this condition will inevitably increase production costs, and it is not conducive to hospital and patient storage.

Method used

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  • Cisatracurium besylate lyophilized preparation composition stable at room temperature and preparation method thereof
  • Cisatracurium besylate lyophilized preparation composition stable at room temperature and preparation method thereof
  • Cisatracurium besylate lyophilized preparation composition stable at room temperature and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Prescription:

[0027]

[0028] Preparation Process:

[0029] Take about 80% of the total amount of water for injection, control the water temperature at 25°C±5°C, add 30g of precisely weighed injection-grade lactose, and 10g of cisatracurium besylate, fully stir until completely dissolved, and measure the pH value. Add benzenesulfonic acid aqueous solution dropwise, control the pH value to about 3.5, add water for injection to the full amount, add 0.1% activated carbon for needles, stir for 30 minutes at 25°C±5°C, sterilize and filter the solution with a 0.22μm microporous filter membrane, and distribute the solution in 7m1 In the standard vials, the filling capacity of each bottle is 5ml.

[0030] Put the prepared vials filled with cisatracurium besylate into a freeze-drying box, and then reduce the temperature in the freeze-drying machine to below -45°C within 2 hours to make it freeze quickly. Vacuumize and make the atmospheric pressure in the box reach 2.66pa...

Embodiment 2

[0032] Prescription:

[0033]

[0034] Preparation Process:

[0035] Take about 80% of the total amount of water for injection, control the water temperature at 25°C ± 5°C, add 40g of precisely weighed mannitol, and 10g of cisatracurium besylate, fully stir until completely dissolved, measure the pH value, drop Add benzenesulfonic acid aqueous solution, control the pH value to be about 3.5, add water for injection to the full amount, add 0.1% activated carbon for needles, stir for 30 minutes at 25°C±5°C, sterilize and filter the solution with a 0.22μm microporous membrane, and pack the solution in 7m1 size In the vials, the volume of each bottle is 5ml.

[0036] Put the prepared vials filled with cisatracurium besylate into a freeze-drying box, and then reduce the temperature in the freeze-drying machine to below -45°C within 2 hours to make it freeze quickly. Vacuumize and make the atmospheric pressure in the box reach 2.66pa within 30 minutes. Dry according to the tem...

Embodiment 3

[0038] Prescription:

[0039]

[0040] Preparation Process:

[0041]Take about 80% of the total amount of water for injection, control the water temperature at 25°C ± 5°C, add 30g of precisely weighed glycine, and 10g of cisatracurium besylate, fully stir until completely dissolved, measure the pH value, add dropwise Aqueous solution of benzenesulfonic acid, control the pH value to about 3.5, add water for injection to the full amount, add 0.1% activated carbon for needles, stir for 30 minutes at 25°C±5°C, sterilize and filter the solution with a 0.22μm microporous filter membrane, and pack the solution in 7m1 size containers In vials, the volume of each bottle is 5ml.

[0042] Put the prepared vials filled with cisatracurium besylate into a freeze-drying box, and then reduce the temperature in the freeze-drying machine to below -45°C within 2 hours to make it freeze quickly. Vacuumize and make the atmospheric pressure in the box reach 2.66pa within 30 minutes. Dry acco...

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PUM

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Abstract

The invention relates to a Cisatracurium besylate lyophilized preparation composition stable at room temperature and a preparation method thereof. The lyophilized preparation contains benzene sulfonic acid Cisatracurium besylate and a lyophilization excipient, a weight ratio of the lyophilization excipient to the benzene sulfonic acid Cisatracurium besylate (W / W) is 1:1-5:1. The lyophilized preparation overcomes the defect of cryopreservation of an existing lyophilized preparation, and is convenient for hospitals and patients for storage. The lyophilized preparation is used for muscle relaxation for operation patients.

Description

1. Technical field [0001] The invention relates to the field of pharmaceutical preparations, and specifically designs a cisatracurium besylate freeze-dried preparation composition stable at room temperature and a preparation method thereof. 2. Background technology [0002] Quaternary salt compounds are widely used and have good development prospects, especially in the pharmaceutical industry as muscle relaxation has been widely concerned, such as atracurium besylate (atracurium) is a classic medium-aging non-detoxifying agent. Polarized muscle relaxants are commonly used in clinical anesthesia, and cisatracurium besylate (cisatracurim) is one of the ten isomers of atracurium besylate, accounting for about the total amount of the mixture It has similar muscle relaxant effect and metabolic mode as atracurium besylate, but its muscle relaxant effect is about 3 times that of atracurium, and does not release histamine. Small, therefore, atracurium cis-besylate is considered a v...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4725A61K47/26A61K47/18A61P21/02
Inventor 徐奎吴仁荣
Owner CUREGEN JIANGSU PHARMA
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