Method for separating and purifying sugammadex

A technology for separating and purifying sugammadex, which is applied in the field of high-efficiency separation and purification of sugammadex, can solve problems such as harm, and achieve the effects of cost reduction, simple and convenient operation, and high yield.

Inactive Publication Date: 2019-03-26
SUZHOU NANOMICRO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

CN201810153493.0 provides a separation and purification method of sugammadex, which describes the separation and purification of C18 reversed-phase column chromatography, the mobile phase is ultrapure water and acetonitrile, and the method uses organic reagents as solvents, which has certain hazards

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  • Method for separating and purifying sugammadex
  • Method for separating and purifying sugammadex
  • Method for separating and purifying sugammadex

Examples

Experimental program
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Effect test

Embodiment 1

[0038] The crude extract of sugammadex with a purity of 93.11% was taken and dissolved in water, and the content of sugammadex in the solution was 50 mg / mL. After the solution was clarified, it was filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use. A chromatographic column of 4.6 × 250 mm was used, and UniDEAE-30S microspheres (produced by Suzhou Nawei Technology Co., Ltd.) were used as the packing material of the chromatographic column, and the packing volume was 4.2 ml. Gradient elution was performed with 20mM sodium acetate solution (phase A) and 20mM sodium acetate + 1M NaCl (phase B) as the mobile phase. Perform pre-column pretreatment on the chromatographic column, first remove impurities with 50% phase B, and then equilibrate with 100% phase A. The flow rate was controlled at 0.4ml / min. The gradient elution process is as follows: wash with 100% A phase for 15 minutes first, then increase the elution concentrat...

Embodiment 2

[0041] The crude sugammadex extract with a purity of 92.55% was taken, dissolved in water, and the sugammadex content in the solution was 50 mg / mL. After the solution was clarified, it was filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use. A chromatographic column of 4.6×250mm was used, and UniQ-30S microspheres were used as the column filler, and the column volume was 4.2ml. Use 20mM sodium acetate solution (phase A) and 20mM sodium acetate + 1MNaCl (phase B) as the mobile phase for gradient elution, and perform pre-column pretreatment on the chromatography column, first use 50% phase B to remove impurities, and then use 100% %A phase for equilibrium. The flow rate was controlled at 0.4ml / min. The gradient elution process is as follows: wash with 100% A phase for 15 minutes, then increase the concentration gradient from 0% B to 4% B within 15-20 minutes, and increase the concentration gradient from 4% B to 8% within...

Embodiment 3

[0043]The crude sugammadex extract with a purity of 92.55% was taken, dissolved in water, and the sugammadex content in the solution was 50 mg / mL. After the solution was clarified, it was filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use. A chromatographic column of 4.6×250 mm was used, and UniDEAE-30S microspheres were used as the column filler, and the column volume was 4.2 ml. Use 20mM sodium acetate solution (phase A) and 20mM sodium acetate + 1MNaCl (phase B) as the mobile phase for gradient elution, and perform pre-column pretreatment on the chromatography column, first use 50% phase B to remove impurities, and then use 100% %A phase to equilibrate. The flow rate was controlled at 0.4ml / min. The gradient elution process was that 10% B was increased to 40% B for 20 column volumes. Collect the solution of the target peak in sections, and summarize the components that meet the requirements. After high performance...

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Abstract

The invention provides a method for efficiently separating and purifying sugammadex. The method comprises the steps that a crude extract of sugammadex is dissolved and filtered; the filtered solutionis subjected to sample loading to exchange resin loaded with a weak anion for chromatography; a salt solution is used as a flow relative target product for elution; and a solution of a target peak iscollected in stages, and a component solution meeting the requirements is summarized. The method is used for deep and pure purification of the sugammadex, only one-step chromatographic purification isneeded to meet the requirement that the purity of the sugammadex is more than 99.0% and the single impurity is less than 0.1%, and the purification yield is high and stable. The method adopts an aqueous solution of sodium acetate and an aqueous solution of sodium chloride as a mobile phase, and does not use an organic solvent, and the adopted mobile phase is safe, non-pollution and low in cost. Meanwhile, the separation method is simple and convenient and can be used for large-scale production, and the production cost is greatly reduced.

Description

technical field [0001] The invention relates to the field of medicine purification, in particular to a method for efficiently separating and purifying sugammadex. Background technique [0002] Sugammadex is a selective antagonist of steroidal muscle relaxants, which is used to rapidly reverse the neuromuscular blockade caused by the anesthetics rocuronium and vecuronium during surgery in adult patients. Sugammadex is a synthetic modified γ-cyclodextrin consisting of a lipophilic core and a hydrophilic outer end. Sugammadex administered by intravenous injection can significantly improve the recovery of muscle relaxation after surgery, and the rapid reversal of the neuromuscular blockade of steroidal muscle relaxants in a short period of time has positive significance for improving the safety of general anesthesia. [0003] The structural formula is as follows: [0004] [0005] At present, most of the reports on sugammadex in domestic and foreign patents and documents ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/16
CPCC08B37/0003C08B37/0012
Inventor 江必旺王希李易
Owner SUZHOU NANOMICRO TECH CO LTD
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