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Method for purifying sugammadex sodium

A technology of sugammadex sodium and a purification method, applied in the field of pharmaceutical synthesis, can solve the problems of low product purity, high solubility, unfavorable environmental protection, etc., and achieve the advantages of improving product yield and purity, avoiding a large amount of waste liquid, and improving yield. Effect

Inactive Publication Date: 2020-04-21
XUZHOU COLLEGE OF INDAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purification method disclosed in patent WO2012 / 025937A1 needs to use silica gel column and Sephadex G25 for column chromatography, and the product purity is still low; although patent CN104844732A is purified by nanofiltration membrane, it can mainly remove small molecules. Limited removal of impurities similar in structure to the target product, high purity cannot be guaranteed
[0008] In summary, the existing technology uses nanofiltration dialysis for purification, which uses a large amount of water and produces a large amount of waste liquid, which is not conducive to environmental protection. After dialysis, the final product is in water. Due to the high solubility of the final product in water, the purification effect is limited. Not conducive to the improvement of product purity

Method used

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

Examples

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Embodiment 1

[0020] Example 1: Purification of Sugammadex Sodium

[0021] Take 81 g of crude sugammadex gluconate, dissolve it in 450 ml of water, adjust the pH to 3 with 35% dilute sulfuric acid, precipitate a solid, wash it twice with acetone, filter with suction, and dry to obtain 65 g of white solid sugammadex gluconic acid; Under the bath, the solid carboxylic acid and 1 g of sodium hydroxide solution were heated to room temperature, and after stirring for 2 h, a clear light yellow solution was obtained, 1500 ml of ethanol was added, a white solid was precipitated, suction filtered, and dried to obtain a white solid sodium gluconate 35.8 g, the yield reached 63.2%, and the purity was 99.2%.

Embodiment 2

[0022] Example 2: Purification of Sugammadex Sodium

[0023] Take 81 g of crude sugammadex gluconate, dissolve it in 450 ml of water, adjust the pH value to 3 with 10% dilute hydrochloric acid, separate out solids, wash with acetone for 3 times, filter with suction, and dry to obtain 65 g of white solid sugammadex gluconic acid; Under the bath, the solid carboxylic acid and 1 g of sodium hydroxide solution were heated to room temperature, and after stirring for 4 hours, a clear light yellow solution was obtained, and 1500 ml of ethanol was added to separate out a white solid, which was filtered and dried to obtain a white solid sodium gluconate 35.6 g. , the yield is 63.0%, and the purity is 99.5%.

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Abstract

The invention belongs to the technical field of medicine synthesis, and particularly relates to a method for purifying sugammadex sodium. The method comprises the following steps: a sugammadex sodiumcrude product is subjected to acetone pulping under an acidic condition and hydrolysis to obtain sugammadex acid, and finally the sugammadex acid and sodium hydroxide are salified to obtain the sugammadex sodium. Compared with the prior art, the method has the advantages as follows: the purity of the sugammadex sodium finished product can be remarkably improved, dialysis and column chromatographyare not needed in the purification process, yield and purity of sugammadex sodium can be improved only through simple hydrolysis, the method is more suitable for industrial production, and the production efficiency is improved.

Description

technical field [0001] The invention belongs to the technical field of drug synthesis, and in particular, the invention relates to a method for purifying sodium sugammadex. Background technique [0002] Sugammadex sodium is used for reversal of steroidal non-depolarizing muscle relaxants such as vecuronium bromide and rocuronium bromide, which have been on the market for many years. Sugammadex sodium is an improved γ-cyclodextrin, water-soluble, is a new type of steroid non-depolarizing muscle relaxant antagonists, can be combined with steroid muscle relaxants such as rocuronium bromide, vecuronium bromide Ammonium, forms an inactive inclusion complex in a 1:1 ratio, hinders its function at the neuromuscular junction, affects the redistribution of steroid muscle relaxants, and accelerates the decomposition of steroid muscle relaxants and nicotinic acetylcholine receptors, Antagonize neuromuscular blocks of varying depths. The structural formula of Sugammadex Sodium is as f...

Claims

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Application Information

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IPC IPC(8): C08B37/16
CPCC08B37/0012
Inventor 李想王德堂李敢位艳宾吴羡
Owner XUZHOU COLLEGE OF INDAL TECH
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