A method for separation and purification of sugammadex

Abstract

The invention discloses a method for separating and purifying sugammadex. Method Firstly, the sugammadex sample is dissolved in a mixed solution, and the insoluble matter is filtered out; then the filtered sample solution is loaded onto the ODS column; then the single-column internal circulation mode or the double-column internal circulation mode is used for separation; finally, the mixed The solvent is used as the mobile phase sample for gradient elution or isocratic elution, the target peak is collected in sections, and the components that meet the requirements of the target peak are collected to obtain the purified sample. The method of the present invention has the advantages of mild separation conditions, high separation efficiency, fast separation speed, and strong versatility. compound with good application prospects.

Description

Technical field [0001] The present invention belongs to the field of drug separation and purification, and in particular to a Shu more glucose separation purification method, using a circulating equipment of the assembled single column or double column circulation, 0.1% trifluoroacetic acid and methanol Or the acetonitrile is a mobile phase, which can obtain high purity comfortable glucose. Background technique [0002] Sugammadex is a derivative after gamma-loop-fritted modified, and the molecular structure retains the gamma cyclic paste. Surgical anesthetic Rocraroammonium bromide, the rapid combination of vitaric bromide, so that the high concentration of muscle pine in the blood and anesthesia tissue is rapidly reversed in a short period of time, so that neuromuscular joints are restored to the normal, which is a significant safety in improving systemic anesthesia. Effect of selective muscle pine antagonist. [0003] Sugammadex molecular formula is as follows: [0004] [0...

AI Technical Summary

Problems solved by technology

[0005] Up to now, the reports on sugammadex in related periodicals and patent works at home and abroad are mostly in terms of process synthesis and clinical application, but there are few reports on its separation and purification methods, with a total of no more than 20 documents, such as CN1402737 reports a method for purifying sugammadex by dialysis, but the recovery rate of this osmosis method is only 34%, which is not conducive to industrial production

CN107892727A invented the purification of sugammadex sodium by using activated carbon, but this method is not conducive to environmental protection

CN108456264A has reported utilizing silica gel C18 to be that the chromatographic column of filler is purified, and this method column packing is comparatively loaded down with trivial details

[0007] Although a variety of methods for purifying sugammadex have been reported in the above literature, most of them are activated carbon adsorption, recrystallization purification and preparative chromatography purification. Large and the product is usually unstable. Because γ-cyclodextrin is highly polar and has many structural analogues, the structure is relatively complex and contains multiple chiral centers, there is almost no retention during the preparation of chromatography, and secondary purification cannot be achieved after the primary purification. Purification, so the cost of purification is high and the amount of solvent used is large. The above methods have certain disadvantages and limitations

Images