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Separation and purification method for 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 short purification cycle and no pollution cost

Active Publication Date: 2015-10-28
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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  • Separation and purification method for dalbavancin
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  • Separation and purification method for dalbavancin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Measure 40 mg / ml crude dalbavancin (58% purity) and dissolve it in 20% ethanol solution, add a certain amount of HCl to dissolve, control the pH value of the solution at 2-5, and perform ultrasonic treatment. After the solution is clarified, filter it with a 0.45μm filter membrane and collect the filtrate for later use. Using 4.6×250mm chromatographic column, Polymer microspheres (produced by Suzhou Nanomicro Technology Co., Ltd.) are used as chromatography column packing with a packed column volume of 4.2ml. Before loading the sample, perform pre-column pretreatment on the chromatographic column, first remove impurities from the high-concentration organic phase, and then balance with the organic phase with a concentration lower than 20%. Then use 0.1% phosphoric acid aqueous solution and methanol solution as mobile phases for gradient elution, and the flow rate is controlled at 1 ml / min. The gradient elution process is as follows: first wash 8 column volumes with a mo...

Embodiment 2

[0028] Measure 40mg / ml crude dalbavancin (58% purity) and dissolve it in 20% ethanol solution, add a certain amount of HCl to dissolve, the pH value of the solution is controlled at 2-5, ultrasonic treatment, after the solution is clear, use a pore size of Filter with 0.45μm filter membrane and collect the filtrate for later use. Using 4.6×250mm chromatographic column, Polymer microspheres (produced by Suzhou Nanomicro Technology Co., Ltd.) are used as chromatography column packing with a packed column volume of 4.2ml. Before loading the sample, perform pre-column pretreatment on the chromatographic column, first remove impurities from the high-concentration organic phase, and then balance with the organic phase with a concentration lower than 20%. Then use 0.1% phosphoric acid aqueous solution and methanol solution as mobile phases for gradient elution, and the flow rate is controlled at 1 ml / min. The gradient elution process is as follows: first wash 8 column volumes with a...

Embodiment 3

[0030] Measure 40mg / ml crude dalbavancin (58% purity) and dissolve it in 20% ethanol solution, add a certain amount of HCl to dissolve, the pH value of the solution is controlled at 2-5, ultrasonic treatment, after the solution is clear, use a pore size of Filter with 0.45μm filter membrane and collect the filtrate for later use. Using 4.6×250mm chromatographic column, Polymer microspheres (produced by Suzhou Nanomicro Technology Co., Ltd.) are used as chromatography column packing with a packed column volume of 4.2ml. Before loading the sample, perform pre-column pretreatment on the chromatographic column, first remove impurities from the high-concentration organic phase, and then balance with the organic phase with a concentration lower than 20%. Then use 0.1% phosphoric acid aqueous solution and methanol solution as mobile phases for gradient elution, and the flow rate is controlled at 1 ml / min. The gradient elution process is as follows: first wash 8 column volumes with a...

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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 is a new semi-synthetic glycopeptide antibiotic. Its mechanism of action is the same as that of vancomycin and teicoplanin. By inhibiting the biosynthesis of the cell wall of G+ bacteria, it can be widely used as a treatment for skin and soft tissue infections. drug. Dalbavancin has unique pharmacokinetic properties, has a 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 the body and is an ideal second-generation glycopeptide antibiotic. [0003] Dalbavancin consists of a similar structure A 0 , A 1 , B 0 , B 1 And B 2 Five components, of...

Claims

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Application Information

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Patent Type & Authority Applications(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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