Preparation method of vancomycin with high purity

A vancomycin, high-purity technology, applied in the field of preparation of high-purity vancomycin, can solve the problems of affecting the separation efficiency, low production efficiency, long separation time, etc., and achieve the purpose of increasing the number of plates, high production efficiency, and time-consuming short effect

Active Publication Date: 2013-11-27
LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

What CN101440127A used was that Sephadex C series resin is filler, with 4-6% (w / v) NH 4 HCO 3 Purified by aqueous solution elution, NH 4 HCO 3 Will decompose and foam, thereby affecting the separation efficiency
In addition, the CN101440127A precipitation method uses the method of adding NaCl to salt out vancomycin, and the salting out takes as long as 24-48 hours (see Examples 17-22), the separation time is long, and the production efficiency is low

Method used

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  • Preparation method of vancomycin with high purity
  • Preparation method of vancomycin with high purity
  • Preparation method of vancomycin with high purity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1NH 4 HCO 3 mobile phase concentration

[0040] Take 2L of vancomycin chromatographic purity of 84%, concentration of 25-30g / L decolorization solution, put it on the column with a loading volume of 30g / L, between pH3.0-4.0, filter with 0.45μm filter membrane, and decolorize A 5.5mm×90cm plexiglass chromatography column of UniPMM50CAR filler resin. After adsorption, wash with pure water with a flow rate of 2.5 times the column volume / hour and 2 times the column volume.

[0041] After washing with pure water, use 0.3% (w / v) NH 4 HCO 3 aqueous solution for pre-washing.

[0042] After prewashing, use 5 times column volume of 0.4% NH 4 HCO 3 Aqueous solution was used as mobile phase to elute vancomycin. Detect the vancomycin purity of the chromatographic collection liquid by HPLC, the detection wavelength is 280nm, when the absorbance rises to 40, start to collect the chromatographic liquid in sections, adjust the pH to 3.0-3.5 with hydrochloric acid, store i...

Embodiment 2

[0047] Example 2NH 4 HCO 3 Mobile phase elution speed

[0048] Take 2L of vancomycin chromatographic purity of 84%, concentration 25-30g / L decolorization solution, put it on the column with a load volume of 30g / L, pH between 3.0-4.0, filter through a 0.45μm filter membrane, and pass the decolorization solution through the UniPMM50CAR A 5.5cm×90cm glass chromatography column of resin. After adsorption, wash with pure water with a flow rate of 2.5 times the column volume / hour and 2 times the column volume.

[0049] After washing with pure water, use 0.3% (w / v) NH 4 HCO 3 aqueous solution for pre-washing.

[0050] After prewashing, wash with 0.4% (w / v) NH 4 HCO 3 Aqueous solution was used as mobile phase to elute vancomycin. Carry out HPLC to detect the vancomycin purity of the chromatographic collection liquid, the detection wavelength is 280nm, when the absorbance rises to 40, start to collect the chromatographic liquid in sections, adjust the pH to 3.0-3.5 with hydroch...

Embodiment 3

[0055] Take 2L of vancomycin chromatographic purity of 84%, concentration 25-30g / L decolorization solution, put it on the column with a load volume of 30g / L, pH between 3.0-4.0, filter through a 0.45μm filter membrane, and pass the decolorization solution through the UniPMM50CAR A 5.5cm×90cm glass chromatography column of resin. After adsorption, wash with pure water with a flow rate of 2.5 times column volume / hour and 5 times column volume.

[0056] After washing with pure water, use 0.3% (w / v) NH 4 HCO 3 aqueous solution for pre-washing.

[0057] After prewashing, use 0.4% (w / v) NH 4 HCO 3 Aqueous solution was used as mobile phase to elute vancomycin. Collect the eluted part in stages with an elution collection tank, and detect it with an ultraviolet detector. The wavelength of the detector is 280nm. Adjust the hydrochloric acid to 3.0-3.5 and store at 4°C.

[0058] table 3

[0059]

[0060] Table 3 is according to the preparation method of vancomycin in embodimen...

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Abstract

The invention belongs to the field of antibiotic preparation technologies, and more specifically relates to a preparation method of vancomycin with high purity. The preparation method comprises following steps: a destaining solution of vancomycin is subjected to column chromatography in a chromatography media, wherein the chromatography media is UniPMM50CAR, the NH4HCO3 mass concentration of a mobile phase of column chromatography is 0.2 to 0.7%; when absorbance rises to 40 at a detection wavelength of 280nm, chromatography liquids are collected segment by segment, the pH value of the chromatography liquids is adjusted to 3.0 to 3.5, the chromatography liquids are preserved under 4 DEG C, and the collected chromatography liquids are mixed. Bubbles in the chromatographic column caused by degradation of carbonate are not likely to generate by using the preparation method. The preparation method is capable of increasing stage number and separation efficiency. The appearance of the obtained vancomycin is improved significantly, purity is as high as 99%, and the vancomycin can be taken orally or by injection.

Description

technical field [0001] The invention relates to the technical field of antibiotic production, in particular to a preparation method of high-purity vancomycin. Background technique [0002] Vancomycin is an amphoteric glycopeptide antibiotic produced by Nocardia orientalis under controlled fermentation conditions, and its chemical formula is C 66 h 75 C l2 N 9 o 24 , the molecular weight is 1486. The fermentative production of vancomycin by the microorganism Amycolatopis orientalis has been described in more detail in US Pat. No. 3,067,099 (filed in 1995) and WO91 / 08,300. Vancomycin is currently the drug of choice for the treatment of penicillin-resistant bacterial infections and β-lactam antibiotic allergies, and is praised by international antibiotic experts as "the last line of defense for humans against stubborn drug-resistant strains." [0003] Vancomycin was originally nicknamed "Mississippi sludge" because the appearance of its early preparations was gray-brown, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K9/00C07K1/22
Inventor 黄志强吕述权黄娟林东态魏华陈秉梅
Owner LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD
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