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Preparation of high-purity vancomycin hydrochloride

A technology of vancomycin hydrochloride and vancomycin, which is applied in the field of purifying vancomycin hydrochloride to achieve the effects of reducing impurities, improving effective components and high purity

Active Publication Date: 2012-10-17
ZHEJIANG NOVUS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In certain utilizations of antibiotics, it is important to reduce possible side effects of high chromatographic purity of antibiotics, which so far cannot be achieved by other existing purification methods

Method used

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  • Preparation of high-purity vancomycin hydrochloride
  • Preparation of high-purity vancomycin hydrochloride
  • Preparation of high-purity vancomycin hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: the preparation of vancomycin crude product

[0032] The vancomycin hydrochloride aqueous solution has a concentration of 120 mg / mL, a volume of 20.0 L, and a vancomycin chromatographic purity of 80.4% (HPLC). The pH of the solution is 3.0, and NH is added while stirring. 4 HCO 3 A total of 1600g, during the process of adding salt, bubbles are constantly generated in the solution, and vancomycin is precipitated from it, forming a slurry, and then adding concentrated ammonia water to adjust the pH to 8.0, this means more vancomycin precipitates, and the slurry is thicker, continue Stir for 50min to make it evenly mixed, stop stirring and let stand for 18 hours, the process temperature is controlled at 14-16°C. The mixture was separated by filtration and top-washed with 5000 mL of ethanol to obtain 4023 g of a wet product of vancomycin base with a titer of 564 μg / mg and a yield of 94.5%. The chromatographic purity of vancomycin detected by vancomycin base ...

Embodiment 2

[0033] Embodiment 2: vancomycin crude product dissolves

[0034] In a glass beaker, 1000 g of crude vancomycin prepared in Example 1 was dissolved in 10.0 L of pure water, stirred, and adjusted to pH=9.0 with 2 mol / L NaOH solution. After complete dissolution, filter, add a small amount of pure water during the filtration, and stop the filtration when the concentration of vancomycin in the residue is 7.3mg / ml and the volume is 1.7L. Collect the filtrate in an acid-resistant reaction tank, and adjust the filtrate to pH=4.5 with 2mol / L HCl solution. Finally, 18.5 L of filtrate was obtained with a concentration of 29.0 mg / mL and a chromatographic purity of 88.2%. See Table 1.

Embodiment 3

[0035] Embodiment 3: vancomycin crude product dissolves

[0036] In a glass beaker, 1000 g of crude vancomycin prepared in Example 1 was dissolved in 3.0 L of pure water, stirred, and adjusted to pH=10.0 with 6 mol / L NaOH solution. After complete dissolution, filter, add a small amount of pure water during the filtration, stop the filtration when the concentration of vancomycin in the residue is 9.4mg / ml and the volume is 1.5L. Collect the filtrate in an acid-resistant reaction tank, and adjust the filtrate to pH=6.0 with 6mol / L HCl solution. Finally, 8.5 L of filtrate was obtained with a concentration of 65.0 mg / mL and a chromatographic purity of 88.5%. See Table 1.

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Abstract

The invention relates to an industrial feasible method for preparing a high-purity vancomycin hydrochloride. The method comprises the following steps of (1) putting a crude vancomycin with the content of vancomycin not less than 80% in a dextran resin glass chromatography column containing the NH4HCO3 mobile phase for column chromatography to obtain an effective chromatography liquid; (2) adding NaCl water solution into the effective chromatography liquid and stirring to produce a deposit; (4) top cleaning by 90% ethanol water solution for a few times and drying to obtain the vancomycin hydrochloride. Effective components of the vancomycin hydrochloride obtained through the method are improved greatly, other impurities are reduced greatly, and the purity is very high; meanwhile, the overall color of the product is improved remarkably, and the product is suitable for oral or injection administration.

Description

technical field [0001] The invention relates to a new method for purifying vancomycin hydrochloride. Specifically, the method first carries out column chromatography in an agarose or dextran gel column containing a saline-water mobile phase and utilizes salt precipitation in saline-water to obtain high-purity vancomycin hydrochloride, the Vancomycin hydrochloride can well meet the needs of oral and parenteral administration. Background technique [0002] Vancomycin hydrochloride is an amphoteric glycopeptide antibiotic produced by Nocardia orientalis under controlled fermentation conditions, and its chemical formula is C 66 h 75 C 12 N 9 o 24 • HCl, molecular weight 1.486. The fermentative production of vancomycin by the microorganism Amycolatopis orientalis has been described in more detail in US Patent 3,067,099 (filed in 1995) and WO 91 / 08,300. The freeze-dried powder of finished vancomycin hydrochloride is off-white, and its aqueous solution is a transparent solut...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K9/00C07K1/22
Inventor 王小勇孙新强
Owner ZHEJIANG NOVUS PHARMA CO LTD
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