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Method for refining sugammadex sodium

A technology of sugammadex sodium and a purification method, applied in the field of pharmaceutical production, can solve the problems of not considering the protection of inert gas atmosphere, increasing the difficulty of purifying products, destroying impurities, etc., and achieving good economy, low cost and less impurities. Effect

Active Publication Date: 2018-03-09
王炳永
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  • 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
This method also does not consider the protection of inert gas atmosphere, and there is no condition to inhibit the increase of sugammadex sodium oxidation impurities

Method used

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  • Method for refining sugammadex sodium
  • Method for refining sugammadex sodium
  • Method for refining sugammadex sodium

Examples

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Effect test

Embodiment 1

[0036] Embodiment 1: Purification of sugammadex sodium

[0037]Take sugammadex sodium crude product 100g, dissolve it with 3L of water until clear, add 3g of glutathione under stirring, under the protection of nitrogen, heat up to reflux, add 8L of acetonitrile to the solution, after adding, stir and cool down to room temperature, there is A large number of white solids were precipitated, filtered by suction, and the pure product of Desugammadex Sodium was 33g, with a purity of 99.56%, see figure 2 .

Embodiment 2

[0038] Embodiment 2: Purification of sugammadex sodium

[0039] Take 100 g of sugammadex sodium crude product, dissolve it with 3 L of water until clear, add 3 g of cysteine ​​under stirring, and raise the temperature to reflux under the protection of nitrogen, and add 8 L of acetonitrile to the solution. After the addition was completed, the temperature was cooled to room temperature with stirring, and a large amount of white solids were precipitated. After suction filtration, 35 g of pure sugammadex sodium was obtained, with a purity of 99.3%.

Embodiment 3

[0040] Embodiment 3: Purification of sugammadex sodium

[0041] Take 100 g of sugammadex sodium crude product, dissolve it with 3 L of water until clear, add 3 g of mercaptoethanol under stirring, and raise the temperature to reflux under nitrogen protection, and add 8 L of acetonitrile to the solution. After the addition was completed, the temperature was lowered to room temperature with stirring, and a large amount of white solids were precipitated. After suction filtration, 28 g of pure sugammadex sodium was obtained, with a purity of 99.2%.

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Abstract

The invention discloses a method for re-crystallizing, refining and purifying sugammadex sodium. The method comprises the following steps: adding a protective agent to crude sugammadex sodium, and performing re-crystallizing under the protection of an inert gas to obtain pure sugammadex sodium, wherein the protective agent is selected from one or a mixture of two or more of mercaptoethanol, mercaptoacetate, mercaptoacetate ester, mercaptopropionate, mercaptopropionate ester, glutathione, cysteine, cystamine, dithioerythritol, dithiothreitol, trisubstituted organophosphorus compounds and trisubstituted organophosphorus compound salts. The method has the advantages of simplicity in operation, high product purity, good economy, and suitableness for industrial production.

Description

technical field [0001] The invention relates to a method for refining sugammadex sodium, and the invention belongs to the technical field of pharmaceutical production. 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 is extremely effective. good 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] Sugammadex sodium is a structurally modified γ-cyclodextrin with a complex structure, and the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/16
CPCC08B37/0012A61K31/724C08B37/0003
Inventor 王炳永
Owner 王炳永
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