Preparation method of vancomycin hydrochloride

A technology of vancomycin hydrochloride and vancomycin, applied in the direction of peptides, etc., can solve the problems of easy corrosion of equipment and difficult crystallization, and achieve the effect of extending the service life and reducing investment.

Inactive Publication Date: 2015-06-03
CHONGQING DAXIN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problem that the crystallization of vancomycin hydrochloride is difficult and the follow-up operation equipment in the process of crystallization, separation and drying is easily corroded, the present invention proposes to increase the concentration of vancomycin hydrochloride by adding inorganic or organic acids other than hydrochloric acid to the crude extract. The crystallization ability of vancomycin and its salts can improve the purity of vancomycin while making it easy to operate and reduce corrosion

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Take 10L of the desorbed vancomycin desorption solution after ion exchange adsorption, which contains 5135mg / L of vancomycin, add sulfuric acid to adjust the pH to 3.0, pass through the decolorization column for decolorization, ultrafiltration and nanofiltration to 500mL, and detect the content of vancomycin in it. 10115mg / L. Under rapid stirring, add sulfuric acid again to adjust the pH to 2.0, raise the temperature to 35°C and maintain the temperature, add 1500mL of 95% ethanol, the addition of ethanol is faster when no crystals are precipitated in the early stage of addition, and reduce the ethanol addition rate after a small amount of crystals are precipitated. stirring speed. After the addition of ethanol, the temperature was lowered to 15°C at a rate of 2.5°C / hour, and stirred at a low speed at this temperature for 1 hour. The crystals were separated by suction filtration and washed with 100mL of 75% ethanol to obtain 39.3g of crystals.

[0022] Add water to diss...

Embodiment 2

[0025] The operation before crystallization was exactly the same as that in Example 1. The obtained solution before crystallization of vancomycin was kept at 28.0° C., and 1200 mL of isopropanol was added as uniformly as possible within 12 hours, and the addition process was maintained with low-speed stirring. After the isopropanol was added, the mixture was stirred at a low speed for 1 hour, the crystals were separated by suction filtration and washed with 100 mL of 75% isopropanol to obtain 37.6 g of crystals.

[0026] Add water to dissolve the crystals to 1.4L, slowly flow through 180mL of 717 resin that has been treated as chlorine form, and eject the vancomycin solution in the resin with 360mL of water after adding the aqueous crystal solution to obtain a volume of 1.75L, containing 37.3% of vancomycin g of vancomycin hydrochloride solution.

[0027] The above solution was freeze-dried to obtain a qualified vancomycin hydrochloride finished product.

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PUM

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Abstract

The invention discloses a preparation method of vancomycin hydrochloride, which comprises the following steps: adding a vancomycin crude extracting solution into any other acid except hydrochloric acid for salification, adding a water-soluble organic solvent to crystallize, dissolving the crystal in water, and exchanging with an anion exchange resin to obtain the hydrochloride. The method can effectively crystallize the vancomycin out of the crude extracting solution, thereby enhancing the vancomycin purity, reducing the equipment corrosion by hydrochloric acid, saving the equipment investment and prolonging the service life of the equipment.

Description

technical field [0001] The invention belongs to the field of medicine extraction and purification, and in particular relates to a preparation method of vancomycin hydrochloride. Background technique [0002] Vancomycin is a widely used antibiotic, and its hydrochloride is clinically used as an injectable drug. [0003] In order to obtain the hydrochloride of vancomycin, various extraction and refining methods such as ion exchange, decolorization, chromatographic separation, ultrafiltration, nanofiltration, crystallization, dissolution, and freeze-drying are required. Among them, the crystallization process can improve the purity of vancomycin and remove some impurities such as pigments. However, due to the slow growth of vancomycin hydrochloride crystals, the crystallization process is easily disturbed by impurities, and the crystallization is difficult. Only the crude extract through ion exchange and decolorization Difficult to crystallize out. At the same time, hydrochlo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K9/00C07K1/36C07K1/30C07K1/18
Inventor 易昆张洪兰
Owner CHONGQING DAXIN PHARMA
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