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Purification method of sugammadex sodium

A sugammadex sodium and purification method technology, which is applied in the field of purifying sugammadex sodium with pretreated Bailu Z activated carbon, can solve the problems of not being able to obtain high-purity sugammadex sodium products, and achieve good industrialization Foreground, accessible, easy-to-operate effects

Active Publication Date: 2021-03-19
HUNAN RHON PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is proposed in the patent document CN107892727A that due to the differences in the production process and material sources of the activated carbons of various manufacturers, the size and distribution of the skeleton pores of the products are very different. Except for Bailu A (SHIRASAGIA) activated carbon, other types of activated carbon products cannot obtain high-purity sugammadex sodium products
The applicant has been engaged in the research and development of sugammadex sodium for a long time and found that the patent document CN107892727A has a technical bias. More R&D work

Method used

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  • Purification method of sugammadex sodium
  • Purification method of sugammadex sodium
  • Purification method of sugammadex sodium

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Experimental program
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Effect test

Embodiment 1

[0041] A purification method of sugammadex sodium of the present invention, comprising the following steps:

[0042] (1) Take 5 g of Egret Z (CARBORAFIN) activated carbon, add it to a three-necked flask, add 100 mL of purified water to the three-necked flask, insert a nitrogen tube under the liquid surface, and continuously fill nitrogen at room temperature (20°C to 30°C) and stir for half an hour , and then suction filtered under the protection of nitrogen to obtain pretreated Egret Z (CARBORAFIN) activated carbon, which was filled with nitrogen and sealed for storage.

[0043] (2) Add 20 g of sugammadex sodium crude product into a 250 mL flask, add 80 mL of purified water to dissolve, add 4 g of the pretreated Egret Z (CARBORAFIN) activated carbon obtained in step (1), under nitrogen protection, room temperature (20 ° C ~ 30 ℃), stirred and adsorbed for 1 hour, filtered to remove gac, and the filtrate was added dropwise with 720mL of methanol to crystallize, solids were prec...

Embodiment 2

[0045] A purification method of sugammadex sodium of the present invention, comprising the following steps:

[0046] (1) Take 5g of Egret Z (CARBORAFIN) activated carbon, add it to a three-necked flask, add 100mL of water to the flask, vacuumize for nitrogen replacement, and add 0.5g of sodium thiosulfate under nitrogen protection at room temperature (20°C~30°C) , stirred for half an hour, suction filtered under nitrogen protection, washed the filter cake with 50 milliliters of nitrogen-saturated purified water, and drained to obtain pretreated Egret Z (CARBORAFIN) activated carbon, which was filled with nitrogen and sealed for preservation.

[0047] (2) Add 20 g of sugammadex sodium crude product into a 250 mL flask, add 80 mL of purified water to dissolve, add 4 g of the pretreated Egret Z (CARBORAFIN) activated carbon obtained in step (1), and stir at 20 ° C to 30 ° C under nitrogen protection Adsorb for 1 hour, filter to remove activated carbon, add 400 mL of ethanol dropw...

Embodiment 3

[0049] A purification method of sugammadex sodium of the present invention, comprising the following steps:

[0050] (1) Take 5 g of Egret Z (CARBORAFIN) activated carbon, add it to a three-necked flask, add 100 mL of water into the flask, vacuumize for nitrogen replacement three times, heat up to 80°C to 85°C under the protection of nitrogen, keep stirring for half an hour, and then Cool to room temperature, suction filter under nitrogen protection, and drain to obtain pretreated Egret Z (CARBORAFIN) activated carbon, which is sealed and stored with nitrogen.

[0051] (2) Add 20 g of sugammadex sodium crude product into a 250 mL flask, add 80 mL of purified water to dissolve, add 4 g of the pretreated Egret Z (CARBORAFIN) activated carbon obtained in step (1), under nitrogen protection, room temperature (20 ° C ~ 30 ℃) stirred and adsorbed for 1 hour, filtered to remove activated carbon, added dropwise 400mL N,N-dimethylformamide to the filtrate to crystallize, solids were pr...

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Abstract

The invention discloses a method for purifying sugammadex sodium. The method comprises the following steps of: pretreating CARBORAFIN activated carbon by adding activated carbon into water and introducing inert gas while stirring at the temperature of 10-50 DEG C (method 1), or by adding activated carbon into water, and adding a reducing agent and performing stirring at the temperature of 10-50 DEG C under the protection of inert gas (method 2), or by adding activated carbon into water, heating to 60-95 DEG C under the protection of inert gas and performing heat preservation for 0.1-5h (method3); and then adding the pretreated CARBORAFIN activated carbon into an aqueous solution of crude sugammadex sodium under the protection of inert gas, stirring and adsorbing, filtering, and then evaporating to dryness or performing separation by crystallization, so as to obtain the sugammadex sodium of which the purity is greater than 99.50% and the individual impurity content is less than 0.1%. The purification method is simple and convenient to operate, low in cost, obvious in effect and high in product purity, and can be used for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a method for purifying sugammadex sodium, in particular to a method for purifying sugammadex sodium by using pretreated Bailu Z (CARBORAFIN) activated carbon. Background technique [0002] Sugammadex sodium is a derivative of γ-cyclodextrin, a selective muscle relaxant antagonist, which was first developed by Organon, which was acquired by Schering-Plough in 2007. ), and in 2009 Schering-Plough merged with Merck. Sugammadex sodium is currently owned and sold by Merck. The structure of this molecular compound is as follows: [0003] [0004] Sugammadex sodium is a modified γ-cyclodextrin with a ring structure composed of 8 glucopyranose, which forms a complex with neuromuscular blocking drugs rocuronium bromide and vecuronium bromide, reducing the binding to The amount of neuromuscular blocking drug available to nicotinic cholinergic receptors at the neuromuscular junction. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/16
CPCC08B37/0012
Inventor 夏钊王成廖志勇其他发明人请求不公开姓名
Owner HUNAN RHON PHARMA
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