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A kind of separation and purification method of dalbavancin

A technology for separation and purification of dalbavancin, applied in peptide preparation methods, chemical instruments and methods, organic chemistry, etc., to achieve the effect of no pollution cost and short purification cycle

Active Publication Date: 2018-09-25
CHANGSHU NANOMICRO BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] At present, there are few reports on the separation and purification methods of dalbavancin in patents and literatures at home and abroad

Method used

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  • A kind of separation and purification method of dalbavancin
  • A kind of separation and purification method of dalbavancin
  • A kind of separation and purification method of dalbavancin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Measure 40 mg / ml crude dalbavancin (58% purity) and dissolve in 20% ethanol solution, add a certain amount of HCl to dissolve, control the pH value of the solution at 2-5, and sonicate. 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. Using 4.6×250mm chromatographic column, Polymer microspheres (produced by Suzhou Nawei Technology Co., Ltd.) were used as chromatography column fillers, and the column volume was 4.2ml. Before loading the sample, pre-column pretreatment is carried out on the chromatographic column, and the high-concentration organic phase is used to remove impurities, and then the organic phase with a concentration of less than 20% is used to balance. Then, 0.1% phosphoric acid aqueous solution and methanol solution were used as the mobile phase for gradient elution, and the flow rate was controlled at 1 ml / min. The gradient elution process is as follow...

Embodiment 2

[0028] Measure the dalbavancin crude product (58% purity) of 40mg / ml and dissolve it in 20% ethanol solution, add a certain amount of HCl to dissolve, the solution pH value is controlled at 2-5, ultrasonic treatment, after the solution is clarified, use a pore size Filter through a 0.45 μm membrane filter and collect the filtrate for later use. Using 4.6×250mm chromatographic column, Polymer microspheres (produced by Suzhou Nawei Technology Co., Ltd.) were used as chromatography column fillers, and the column volume was 4.2ml. Before loading the sample, pre-column pretreatment is carried out on the chromatographic column, and the high-concentration organic phase is used to remove impurities, and then the organic phase with a concentration of less than 20% is used to balance. Then, 0.1% phosphoric acid aqueous solution and methanol solution were used as the mobile phase for gradient elution, and the flow rate was controlled at 1 ml / min. The gradient elution process is as fol...

Embodiment 3

[0030] Measure the dalbavancin crude product (58% purity) of 40mg / ml and dissolve it in 20% ethanol solution, add a certain amount of HCl to dissolve, the solution pH value is controlled at 2-5, ultrasonic treatment, after the solution is clarified, use a pore size Filter through a 0.45 μm membrane filter and collect the filtrate for later use. Using 4.6×250mm chromatographic column, Polymer microspheres (produced by Suzhou Nawei Technology Co., Ltd.) were used as chromatography column fillers, and the column volume was 4.2ml. Before loading the sample, pre-column pretreatment is carried out on the chromatographic column, and the high-concentration organic phase is used to remove impurities, and then the organic phase with a concentration of less than 20% is used to balance. Then, 0.1% phosphoric acid aqueous solution and methanol solution were used as the mobile phase for gradient elution, and the flow rate was controlled at 1 ml / min. The gradient elution process is as fol...

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Abstract

The invention provides a separation and purification method for dalbavancin. The method comprises the following steps: dissolving and filtering a crude dalbavancin extract; loading a sample of a crude solution obtained after filtering into a chromatographic column equipped with polystyrene high-molecular polymer microspheres for chromatography; carrying out gradient elution on a target product with an aqueous phosphoric acid solution and an organic solvent as mobile phases; and collecting solutions with a target peak value in sections and combining constituent solutions meeting requirements. The separation and purification method is simple, can realize large-scale production and has a high and stable recovery rate.

Description

technical field [0001] The invention relates to the field of medicine purification, in particular to a method for efficiently separating and purifying dalbavancin. Background technique [0002] Dalbavancin (Dalbavancin) is a new type of semi-synthetic glycopeptide antibiotics. Its mechanism of action is the same as that of vancomycin and teicoplanin. It can be widely used as a drug for the treatment of skin and soft tissue infections by inhibiting the biosynthesis of the cell wall of G+ bacteria. drug. Dalbavancin has unique pharmacokinetic properties, long half-life, can be administered at weekly intervals, and can be completely metabolized. At present, dalbavancin has achieved good results in the treatment of catheter-related blood-borne infections and skin and soft tissue infections. It has excellent antibacterial activity and safety in vivo, and is an ideal second-generation glycopeptide antibiotic. [0003] Dalbavancin consists of structurally similar A 0 、A 1 , B ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K9/00C07K1/16
Inventor 江必旺吴俊成陈荣姬潘毅
Owner CHANGSHU NANOMICRO BIOTECHNOLOGY CO LTD
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