Sugammadex sodium for injection and preparation method thereof

A sugammadex sodium injection technology, applied in chemical instruments and methods, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., to achieve large specific surface area, improve purity, and improve adsorption efficiency Effect

Active Publication Date: 2022-07-22
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The further technical problem to be solved in the present invention is that sugammadex sodium can cause turbidity due to poor solvent crystallization, lyophilization, spray drying, etc. in the purification process. The purpose is to provide sugammadex sodium for injection. In the process of preparing sugammadex sodium injection, adding ammonia water and heating can make the substances that cause turbidity and form visible. The substances of foreign matter are precipitated and removed by filtration, which improves the quality and safety of sugammadex

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example

[0044] The preparation of magnetic nanotubes with a surface-activated nanotube layer-magnetic material layer-mesoporous silica layer structure includes the following steps:

[0045] 1) Preparation of nanotube layer: put 1 gram of carbon nanotubes into a 200-mL flask, add 100 mL of ethanol, 50 mL of water, and 6.9 mL of ammonia water (28 wt %) in turn and stir well; then, add 1 mL of ethyl orthosilicate ester, centrifuged after the reaction is completed; washed with a mixed solvent of ethanol and water for several times, centrifuged, and dried at room temperature for 12 hours to obtain a carbon nanotube-dense silica nanotube core-shell structure;

[0046] 2) Preparation of magnetic material layer: adding FeCl to 1) solution 2 and FeCl 3 The mixed solution was sonicated for 50 min, and the solution was filtered off; the filter cake was added to the sodium hydroxide solution, stirred and sonicated, and then reacted at 110-130 °C for 2-3 h, the liquid was removed and dried to for...

Embodiment 1

[0051] A method for preparing sugammadex sodium provided in the embodiment of the present invention comprises the following steps:

[0052] 1) Dissolve 10.0 g of crude sodium gluconate in 190 mL of deionized water, stir and dissolve at 50°C, and add an appropriate amount of lye to adjust the pH of the solution to 6.7;

[0053] 2) Take 20g of surface-activated magnetic nanotubes and place it in a container and pump it to a vacuum state; 2) Pour the above solution into a container under vacuum state, heat and stir for adsorption for 35min, restore the normal pressure state, and continue to heat and stir for adsorption for 35min , the heating temperature is maintained at 45 ℃, so that the sodium gluconate is fully adsorbed on the inner and outer walls of the nanotubes;

[0054] 3) After the adsorption is completed, the reaction system is cooled down to room temperature, and the magnetic nanotube is separated from the solid-liquid separation through a magnetic field;

[0055] 4) ...

Embodiment 2

[0059] A method for preparing sugammadex sodium provided in the embodiment of the present invention comprises the following steps:

[0060] 1) Dissolve 20.0 g of crude sodium gluconate in 380 mL of deionized water, stir and dissolve at 50°C, and add an appropriate amount of lye to adjust the pH of the solution to 6.9;

[0061] 2) Take 35g of surface-activated magnetic nanotubes and place it in a container and pump it to a vacuum state; 2) Pour the above solution into a container under vacuum state, heat and stir for adsorption for 40min, restore the normal pressure state, and continue to heat and stir for adsorption for 40min , the heating temperature is maintained at 50 ℃, so that the sodium gluconate is fully adsorbed on the inner and outer walls of the nanotubes;

[0062] 3) After the adsorption is completed, the reaction system is cooled down to room temperature, and the magnetic nanotube is separated from the solid-liquid separation through a magnetic field;

[0063] 4) ...

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PUM

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Abstract

The invention discloses sugammadex sodium for injection and a preparation method thereof, and the preparation method comprises the following steps: S1, dissolving a sugammadex sodium crude product in deionized water, and adding a proper amount of alkali liquor to adjust the pH value of the solution to 6.7-6.9; s2, adding a magnetic nanotube into the alkalized solution, and stirring and adsorbing in a vacuum environment; s3, separating the magnetic nanotubes by using a magnetic field, and dispersing the magnetic nanotubes into deionized water for oscillation desorption; wherein the magnetic nanotube comprises a multi-layer structure, and the multi-layer structure sequentially comprises a compact silicon dioxide nanotube layer, a Fe3O4 layer and a mesoporous silicon dioxide layer from inside to outside; and S4, merging and crystallizing the sugammadex sodium solution obtained by oscillation desorption to obtain refined sugammadex sodium. In a weak acid environment, sugammadex sodium molecules are reversibly adsorbed by adopting a special structure of the magnetic nanotube, and the inner layer of the silicon dioxide nanotube and the outer layer of the mesoporous silicon dioxide layer can be subjected to a physical adsorption reaction with the sugammadex sodium molecules through hydrogen bonds, surface atomic coordination and the like.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a kind of sugammadex sodium for injection and a preparation method. Background technique [0002] Sugammadex sodium (sugammadex sodium, trade name Bridion) is a modified gamma cyclodextrin, a chemical modification of cyclodextrin, and a steroid non-depolarizing muscle relaxant antagonist. Body muscle relaxants form inactive inclusion complexes and antagonize neuromuscular blockades of varying depths. Sugammadex sodium is obtained by replacing all the 6-position hydroxyl groups in the 8 glucopyranose units of γ-cyclodextrin with carboxyethylthio groups. The synthesis method can be obtained by nucleophilic substitution reaction of 6-perdeoxy-6-perhalogenated-γ-cyclodextrin with 3-mercaptopropionic acid derivatives under alkaline conditions. [0003] At present, the purification process of crude gluconate sodium gluconate mostly adopts activated carbon adsorption or resin adsorpt...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/16A61K9/08A61K47/04A61K31/724A61P21/00B01J20/20B01J20/30B01J20/10C01B33/18C01G49/08B82Y30/00B82Y40/00
CPCC08B37/0003C08B37/0012A61K9/0019A61K9/08A61K47/02A61K31/724C01G49/08C01B33/18B82Y40/00B82Y30/00B01J20/205B01J20/103A61P21/00C01P2004/82C01P2004/16
Inventor 王静冯舟瞿云安
Owner SICHUAN PHARMA
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