Method for purifying sugammadex sodium

A technique of sugammadex sodium and a purification method, which is applied in the field of drug synthesis, can solve problems such as low product purity and limited production capacity, and achieve the effects of increasing yield and purity and improving production efficiency

Active Publication Date: 2016-02-24
SUZHOU NHWA PHARM RES CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] EP2609120 reports another purification method, which still needs to be purified through a column, through silica gel column and Sephadex G25, the production capacity is limited in industrialization, and the product purity is low

Method used

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  • Method for purifying sugammadex sodium
  • Method for purifying sugammadex sodium
  • Method for purifying sugammadex sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0025] Embodiment 1: Purification of sugammadex sodium

[0026] Take 45 g of crude sugammadex sodium, dissolve it in 250 ml of water, adjust the pH value to 3 with 10% dilute hydrochloric acid, and precipitate a solid, beating and washing with water twice, suction filtration, and drying to obtain 36 g of sugammadex as a white solid.

[0027] Take 36g of the white solid prepared in the previous step and stir with 0.95g of ammonia water to obtain a clear light yellow solution. Add 1000ml of ethanol to precipitate a white solid, filter it with suction, and dry it in vacuo to obtain 30g of the white solid. Dilute the white solid with ethylene glycol / water Crystallized to a white solid, and dried to give sugammadex ammonium salt as a white solid.

[0028] Dissolve the dried sugammadex ammonium salt obtained in the previous step with 250ml of water, adjust the pH value to 3 with 10% dilute hydrochloric acid, precipitate a solid, wash twice with water, filter with suction, and dry to...

Embodiment 2

[0029] Embodiment 2: Purification of sugammadex sodium

[0030] Take 45g of sugammadex sodium crude product, dissolve it in 250ml of water, adjust the pH value to 3 with 20% dilute hydrochloric acid, and precipitate a solid, beating and washing with water twice, suction filtration, and drying to obtain 36g of white solid sugammadex

[0031] Take 36g of the white solid prepared in the previous step, feed ammonia gas, stir and react to obtain a clear light yellow solution, add 1000ml of ethanol, precipitate a white solid, filter with suction, and dry in vacuo to obtain 30g of a white solid. Recrystallize from water to obtain white solid, and dry to obtain sugammadex ammonium salt as white solid.

[0032] Dissolve the dried sugammadex ammonium salt obtained in the previous step with 250ml of water, adjust the pH value to 3 with 20% dilute hydrochloric acid, precipitate a solid, wash twice with water, filter with suction, and dry to obtain sugammadex as a white solid Carboxylic a...

Embodiment 3

[0033] Embodiment 3: Purification of sugammadex sodium

[0034] Take 45g of sugammadex sodium crude product, dissolve it in 250ml of water, adjust the pH value to 5 with 5% dilute hydrochloric acid, and precipitate a solid, beating and washing with water twice, suction filtration, and drying to obtain 36g of white solid sugammadex

[0035] Take 36 g of the white solid sugammadex prepared in the previous step and stir with 0.63 ammonia water to obtain a clear light yellow solution. Add 1000 ml of ethanol to precipitate a white solid, filter it with suction, and dry it in vacuum to obtain 30 g of the white solid. Alcohol / water recrystallization to give white solid, drying to give sugammadex ammonium salt as white solid.

[0036] Dissolve the dried sugammadex ammonium salt obtained in the previous step with 250ml of water, adjust the pH value to 5 with 5% dilute hydrochloric acid, precipitate a solid, wash twice with water, filter with suction, and dry to obtain sugammadex as a w...

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Abstract

The invention discloses a method for purifying sugammadex sodium. The method for purifying sugammadex sodium comprises the steps of hydrolyzing a mmadex ammonium salt under acidic conditions, and carrying out a salt forming reaction with suga sodium hydroxide, thereby obtaining sugammadex sodium. Compared with the prior art, the method provided by the invention has the advantages that the purity of the sugammadex sodium finished product can be remarkably improved; dialysis and column chromatography are not used during purification; and the yield and purity of sugammadex sodium can be remarkably improved by only adopting simple steps such as hydrolysis and recrystallization, so that the method is more applicable to industrial production, and the production efficiency is increased.

Description

technical field [0001] The invention belongs to the technical field of drug synthesis, in particular, the invention relates to a method for purifying sugammadex sodium. Background technique [0002] Sugammadex sodium was approved for marketing by the European Union on July 5, 2008, and is used for reversal of steroidal non-depolarizing muscle relaxants such as vecuronium bromide and rocuronium bromide. Sugammadex sodium is an improved γ-cyclodextrin, which is water-soluble, and is a new type of steroidal non-depolarizing muscle relaxant antagonist, which can be combined with steroidal muscle relaxants such as rocuronium bromide and vecuronium Ammonium forms an inactive inclusion complex at a ratio of 1:1, which hinders its function at the neuromuscular junction, affects the redistribution of steroidal muscle relaxants, and accelerates the decomposition of steroidal muscle relaxants and nicotinic acetylcholine receptors. Antagonizes neuromuscular blocks of varying depths. T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/16
Inventor 陈寅王圣庆李自强杨相平张桂森
Owner SUZHOU NHWA PHARM RES CO LTD
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