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Purification method for sugammadex sodium

A technique of sugammadex sodium and a purification method, which is applied in the field of purification, can solve problems such as inconvenient operation, dissociation, and destruction of impurities, and achieve good removal effect, good economy, and reduced difficulty

Active Publication Date: 2017-04-19
王立燕
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method does not use column chromatography, dialysis and other methods, but the steps are cumbersome, requiring multiple conversions between free acid and salt, and the operation is inconvenient
In addition, due to the instability of sugammadex’s own structure, there is a risk of dissociation of sugammadex’s own structure during the dissociation process under acidic conditions, forming acidic damage impurities, which increases the difficulty of purifying the product

Method used

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  • Purification method for sugammadex sodium
  • Purification method for sugammadex sodium
  • Purification method for sugammadex sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: Transformation of ion resin

[0036] 1) Take 1L of D001 strong acidic cation exchange resin, put it into a sand core plate chromatography column, wash the resin with 0.5mol / L NaOH solution for 4 column volumes, the flow rate is 5ml / min, and then wash it with 0.5mol / L NaOH solution Rinse the resin with HCl solution for 4 column volumes at a flow rate of 5 ml / min. After washing, wash with purified water until neutral.

[0037] 2) Take 0.5L of D001 strongly acidic cation exchange resin treated in step 1, add calcium hydroxide suspension (80g dispersed in 1L of water), stir for 2 hours, rinse the resin with purified water until it is clear, set it aside for use, and mark To transform into ion resin A; get the remaining 0.5L D001 strongly acidic cation exchange resin treated in step 1, add an aqueous solution of sodium hydroxide (60g dissolved in 1L water), stir for 2 hours, and rinse the resin to neutral with purified water , placed for use, marked as transit...

Embodiment 2

[0038] Embodiment 2: Purification of sugammadex sodium

[0039]Take 40 g of sugammadex sodium crude product, dissolve it with 3 L of water until it is clear, add about 0.5 L of transionic resin A under stirring, stir at room temperature for 2 hours, a large amount of white solid precipitates, filter with suction, and rinse the filter cake with purified water to obtain a white Solid (sugammadex calcium) 89 grams, add sugammadex calcium into a 500mL three-necked bottle, add 300g of purified water, under nitrogen protection, heat to 80°C and stir for 2 hours, cool down to room temperature, and suction filter to obtain white Solid (purified sugammadex calcium) 32g.

[0040] Put 32g of purified sugammadex calcium into a 3L three-necked bottle, add a mixed solvent of 1L of purified water and 1L of ethanol to the three-necked bottle, add about 0.3L of transition ion resin B, stir for 2 hours, and filter with suction. Add 0.2L of inversion ion resin B, stir for 2 hours, filter with s...

Embodiment 3

[0044] Embodiment 3: Transformation of ion resin

[0045] 1) Take 1L of 732 strong acidic cation exchange resin, put it into a sand core plate chromatography column, wash the resin with 0.5mol / L NaOH solution for 4 column volumes, the flow rate is 5ml / min, and then wash it with 0.5mol / L HCl The solution washes the resin for 4 column volumes, and the flow rate is 5ml / min. After washing, wash with purified water until neutral.

[0046] 2) Take 0.5L of the 732 strongly acidic cation exchange resin treated in step 1), add magnesium hydroxide suspension (80g dispersed in 1L of water), stir for 2 hours, rinse the resin with purified water until it is clear, and set aside for use. Mark it as transition ion resin A; take the remaining 0.5 L of 732 strongly acidic cation exchange resin treated in step 1) and put it aside for use.

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Abstract

The invention discloses a purification method for sugammadex sodium. The purification method comprises the following steps: 1) putting a part of cation exchange resin into a suspension or solution of a metal hydroxide or metal salt for soaking and carrying out flushing so as to obtain transformed ion exchange resin A, and putting the other part of the cation exchange resin into an aqueous solution of sodium hydroxide for soaking and carrying out flushing so as to obtain transformed ion exchange resin B; and 2) treating a crude sugammadex sodium product with the transformed ion exchange resin A so as to accordingly convert the crude sugammadex sodium product into a sugammadex salt with water-solubility less than sugammadex sodium, then carrying hot slurrying and purification and carrying out conversion via the transformed ion exchange resin B so as to obtain sugammadex sodium, or carrying out conversion via sodium hydroxide after treatment with the cation exchange resin so as to obtain sugammadex sodium. The method provided by the invention can substantially improve the purity of sugammadex sodium, reduces purification difficulty of sugammadex sodium, exerts good removal effect on impurities in the crude sugammadex sodium product, has good economical efficiency and is better applicable to industrial production.

Description

technical field [0001] The invention relates to the field of purification, in particular to a method for purifying sugammadex sodium. Background technique [0002] The chemical name of sugammadex sodium is 6A, 6B, 6C, 6D, 6E, 7F, 6G, 6H-octa-S-(2-carboxyethyl)-6A, 6B, 6C, 6D, 6E, 7F, 6G, 6H-octathio-γ-cyclodextrin, octasodium salt, the structural formula is: [0003] [0004] Sugammadex sodium is a new type of muscle relaxant reversal agent developed by Organon in the Netherlands. It is clinically used to reverse the neuromuscular blockade of rocuronium or vecuronium. It has a good curative effect and has excellent security. Since the European Union approved its listing in July 2008, it has been listed in Japan, South Korea, the United States and other countries, and is applying for production and listing in my country. [0005] At present, there are few reports on the preparation process of sugammadex sodium at home and abroad, and the basic purification process relie...

Claims

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Application Information

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IPC IPC(8): C08B37/16
CPCC08B37/0012
Inventor 王炳永
Owner 王立燕
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