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

Method used

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

Examples

Experimental program
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Example Embodiment

[0035] Example 1: Transformation of ionic resins

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

[0037] 2) Take 0.5L of the D001 strong acid cation exchange resin treated in step 1, add a suspension of calcium hydroxide (80g dispersed in 1L water), stir for 2 hours, rinse the resin with purified water until clear, leave it for use, mark It is transformation ion resin A; take the remaining 0.5L of D001 strong acid cation exchange resin treated in step 1, add an aqueous solution of sodium hydroxide (60g dissolved in 1L water), stir for 2 hours, rinse the resin with purified water to neutrality , set aside for use, marked as transforma...

Example Embodiment

[0038] Example 2: Purification of Sugammadex Sodium

[0039]Take 40 g of the crude product of sodium gluconate, dissolve it with 3 L of water until it becomes clear, add about 0.5 L of ionic resin A under stirring, and stir at room temperature for 2 hours. 89 grams of solid (sugar gluconate calcium) was added to a 500mL three-necked flask, 300g purified water was added, under nitrogen protection, heated to 80 ° C and stirred for 2 hours, cooled to room temperature, and suction filtered to obtain a white Solid (purified sugammadex calcium) 32g.

[0040] Put 32g of purified calcium gluconate in a 3L three-necked flask, add a mixed solvent of 1L of purified water and 1L of ethanol to the there-necked flask, add about 0.3L of transformation ion resin B, stir for 2 hours, suction filtration, and in the filtrate. Add 0.2L of transformation ion resin B, stir for 2 hours, suction filtration, adjust the pH of the filtrate to 7.5-8.5 with 0.1mol / L NaOH solution, and concentrate the fil...

Example Embodiment

[0044] Example 3: Transformation of ionic resins

[0045] 1) Take 1L of 732 strong acid cation exchange resin, put it into the sand core plate chromatography column, rinse the resin with 0.5mol / L NaOH solution for 4 column volumes, the flow rate is 5ml / min, and then use 0.5mol / L HCl The solution was used to rinse the resin for 4 column volumes, and the flow rate was 5 ml / min. After the rinse was completed, it was rinsed with purified water until neutral.

[0046] 2) Take 0.5L of the 732 strongly acidic cation exchange resin processed in step 1), add a suspension of magnesium hydroxide (80g is dispersed in 1L of water), stir for 2 hours, rinse the resin with purified water until clear, leave it for use, It is marked as transformed ion resin A; take the remaining 0.5L of the 732 strong acid cation exchange resin treated in step 1) and set 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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