A kind of purification method of sugammadex sodium

A technology of sugammadex sodium and a purification method, which is applied in the field of purification of muscle relaxant antagonist sugammadex sodium, can solve the problems such as the difference in molecular weight and molecular size between impurities and sugammadex sodium, and achieves good industrialization prospects. , low cost and easy operation

Active Publication Date: 2019-12-24
HEFEI BOSIKC PHARMTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, there are certain differences in molecular weight and molecular size between impurities and sugammadex sodium

Method used

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  • A kind of purification method of sugammadex sodium
  • A kind of purification method of sugammadex sodium
  • A kind of purification method of sugammadex sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1: the pretreatment of active carbon

[0056] Under nitrogen protection, take Special Egret (TOKUSEI SHIRASAGI) 5 grams of activated carbon and 100ml of purified water are added to a 250ml three-necked bottle, which is equipped with a mechanical stirrer and connected to a vacuum device. Under stirring, vacuumize and replace with nitrogen to maintain the nitrogen atmosphere, and heat the water / activated carbon mixture in the bottle to boiling. After keeping boiling for 0.5 hour, stop heating and cool down to room temperature. Nitrogen pressure filtration, the obtained filter cake is pretreated activated carbon, which is filled with nitrogen and stored for later use.

Embodiment 2

[0057] Embodiment 2: the pretreatment of active carbon

[0058] Under nitrogen protection, take egret Add 5 grams of A (SHIRASAGIA) activated carbon and 100ml of purified water into a 250ml three-necked bottle, which is equipped with a mechanical stirrer and connected to a vacuum device. Under stirring, vacuumize and replace with nitrogen to maintain the nitrogen atmosphere, and heat the water / activated carbon mixture in the bottle to boiling. After keeping boiling for 0.5 hour, stop heating and cool down to room temperature. Nitrogen pressure filtration, the obtained filter cake is pretreated activated carbon, which is filled with nitrogen and stored for later use.

Embodiment 3

[0059] Example 3: Purification of crude sugammadex sodium.

[0060] Add 10g of sugammadex sodium crude product into a 250ml three-neck bottle, dissolve in 50ml of freshly boiled cold water In, under the protection of nitrogen, add the pretreated prepared in Example 1 Special Egret (TOKUSEI SHIRASAGI) activated carbon 1g, stirred and adsorbed for 2 hours. The activated carbon was filtered out, and the obtained aqueous solution was concentrated to obtain 9.2 g of pure sugammadex sodium, with a purity of 100.0% (sugammadex sodium+monohydroxy sugammadex sodium). The HPLC diagram is shown in figure 1 .

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Abstract

The invention discloses a purifying method for a crude sugammadex sodium product. The purifying method comprises the following steps by adopting specific active carbon for purification: pretreatment of active carbon, dissolution of the crude sugammadex sodium product, and purification of the crude sugammadex sodium product. According to the invention, the crude sugammadex sodium product is dissolved in water or a composition of water and a sugammadex sodium poor solvent, and pretreated specific active carbon is added into a mixed solution, so sugammadex sodium with high purity is finally obtained. The sugammadex sodium purified by using the method provided by the invention has a purity of larger than 99.50%, and a single impurity of less than 0.1%. The purifying method provided by the invention has the advantages of simple and convenient operation, low cost and good industrial prospects.

Description

technical field [0001] The invention relates to a purification method of sugammadex sodium, a muscle relaxant antagonist, specifically, by adding pretreated activated carbon of a specific brand and specific specification, utilizing the pore size of the specific activated carbon and the crude product of sugammadex sodium The pairing effect of impurities and the corresponding hydrogen bond adsorption force are used to purify the crude product to obtain high-purity sugammadex sodium. Background technique [0002] Sugammadex sodium is a derivative of γ-cyclodextrin, its molecule is composed of a lipophilic core and a hydrophilic outer end, it is a selective muscle relaxant antagonist, and its molecular formula is C 72 h 104 Na 8 o 48 S 8 , the structure of the compound is as follows: [0003] [0004] Sugammadex sodium is a modified γ-cyclodextrin oligosaccharide, which is based on synthetic cyclodextrin and is water-soluble. With a lipophilic core, Sugammadex can wrap ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/16
CPCC08B37/0012
Inventor 郭辉
Owner HEFEI BOSIKC PHARMTECH CO LTD
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