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Method for efficiently separating and purifying caspofungin

A separation and purification, caspofungin technology, applied in the field of high-efficiency separation and purification of caspofungin, can solve the problems of low product purity, low process efficiency, low sample loading, etc., and achieves good repeatability and solvent consumption. Fewer, faster separation effects

Inactive Publication Date: 2018-07-06
浙江华谱新创科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent CN104250290 discloses a method for separating and purifying caspofungin using C18 reverse-phase chromatographic filler as the stationary phase. The purity of caspofungin obtained by this method is about 97%, but it does not involve the control of the key impurity A of caspofungin
Chinese patent CN102076707 (WO2009158034) discloses the use of reverse-phase chromatographic packing (C8 or C18) as the separation medium, which can control the lower content of impurity A, but requires at least 2 reverse-phase chromatographic column separation and purification
[0007] Most of the existing technologies in the preparation process have low process efficiency, low sample loading, low purity of purified products and high energy consumption

Method used

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  • Method for efficiently separating and purifying caspofungin
  • Method for efficiently separating and purifying caspofungin
  • Method for efficiently separating and purifying caspofungin

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Experimental program
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Effect test

Embodiment 1

[0027] Caspofungin crude product 1g is dissolved in 10mL ethanol-ammonium perchlorate solution, the injection volume is 10mL, and the loading volume is 0.33%; a hydrophilic silica gel column (column specification 50×250mm, particle diameter 10 μm) bonded with a carboxyl group is used , aperture Packing quality 300g), flow rate 100mL / min; Immediately after loading the sample, use 77% (V / V) ethanol-10mM ammonium perchlorate solution for isocratic elution; UV detector, detection wavelength 220nm, starting from the target peak The fraction is connected until the peak returns to the baseline and stops. After desalination, a product with a purity of caspofungin of more than 99.1% and an impurity A0 of less than 0.1% can be obtained.

Embodiment 2

[0029] Other conditions are identical with embodiment 1, and difference is that filler aperture is After purification and desalination, a product with a purity of more than 99.5% of caspofungin and an impurity A0 of less than 0.1% can be obtained.

Embodiment 3

[0031] Other conditions are identical with embodiment 1, and difference is to use carboxyl hydrophilic silica gel column (column specification 50 * 1000mm, particle diameter 30 μ m, pore diameter Filler quality 1.2kg), desalting after purification can obtain the product that caspofungin purity is more than 99.5%, and impurity A0 is less than 0.1%.

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Abstract

A purpose of the present invention is to provide a method for separating and purifying caspofungin. The method is characterized in a silica gel hydrophilic material with a polar group modified on thesurface is used, a caspofungin crude product is dissolved with a certain proportion of an organic solvent-buffer salt solution, the obtained sample is injected, elution is performed with a certain proportion of an organic solvent-buffer salt solution, purification is performed, and desalting is performed to obtain the caspofungin with a chromatographic purity of greater than 99% and a key impurityA0 of less than 0.1%. With the method of the present invention, the efficient separation purification and preparation of caspofungin is achieved, and the method has advantages of good stability, highsample injection amount, easy operation, controllability and the like, and is suitable for the separation and purification in the production.

Description

technical field [0001] The invention belongs to the technical field of separation, purification and purification of caspofungin, and particularly provides a high-efficiency separation and purification method of caspofungin. Background technique [0002] Caspofungin is a macrocyclic lipopeptide from the echinocandin family, which can inhibit the synthesis of β-(1,3)-D-glucan in the cell wall of many filamentous fungi and yeast, destroying the integrity of the cell wall, and Produces a fungicidal effect. The structural formula of caspofungin is as follows: [0003] [0004] Caspofungin is a semi-synthetic derivative of pneumocandine B0 (neumocantine B0), which is synthesized from the fermentation product of Glarea Lozoyensis. The synthesized caspofungin must be separated and purified before reaching the purity of pharmaceutical standards. [0005] Impurities in drugs generally have no therapeutic effect, and some have certain toxicity, which is the main factor affecting ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K7/56C07K1/16
CPCC07K7/56
Inventor 周永正张亚辉张雁王科然吴元华
Owner 浙江华谱新创科技有限公司
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