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Preparation method of caspofungin acetate impurity E

A technology of caspofungin acetate and impurities, which is applied in the chemical field to achieve the effect of high yield and stable conditions

Pending Publication Date: 2021-12-17
HANGZHOU ZHONGMEI HUADONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] In the prior art, there is no relevant report about the preparation of high-purity caspofungin acetate impurity E. Therefore, a method for preparing high-purity caspofungin acetate impurity E needs to be developed to meet the needs of the enterprise itself and the market. Need for Caspofungin Acetate Impurity E Reference Substance

Method used

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  • Preparation method of caspofungin acetate impurity E
  • Preparation method of caspofungin acetate impurity E
  • Preparation method of caspofungin acetate impurity E

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0032] First, determine the mobile phase, packing material, and elution gradient.

[0033] First, we use acidic water as mobile phase A, and acetonitrile as mobile phase B. Since the stability of super antibiotic products is generally poor, it is necessary to further investigate the preparation stability of the product. Therefore, we use aqueous solutions with different acidities for preparation. The results are shown in the table 1.

[0034] Table 1 The influence of mobile phase A with different acidity on the purity of impurity E in the collected components

[0035]

[0036] According to the data in Table 1, it can be seen that impurity E shows different stability under different acidic and alkaline conditions, wherein under acidic conditions, impurity E shows strong stability, and under alkaline conditions, the product is extremely unstable And the purity obviously drops, so select 0.1% acetic acid aqueous solution as aqueous phase mobile phase A for use, mobile phase B...

Embodiment 2

[0049] According to the same method and chromatographic conditions as in Example 1, 4 g of crude product E with a purity of 48% was dissolved in 0.1% acetic acid aqueous solution, and the gradient eluent impurity E content collected at last had a purity of more than 95%, and was freeze-dried to obtain The solid powder of 1.1g impurity E, product total yield is 55%, and product purity is 96.46%.

Embodiment 3

[0051] According to the same method and chromatographic conditions as in Example 1, 5 g of crude product E with a purity of 48% was dissolved in 0.1% acetic acid aqueous solution, and the content of impurity E in the gradient eluent collected at last was more than 95% in purity, and 1.4 was obtained after lyophilization. The solid powder of g impurity E, product total yield is 57%, and product purity is 95.83%.

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Abstract

The invention relates to a preparation method of a caspofungin acetate impurity E. The preparation method comprises the following steps of 1) preparing a caspofungin acetate impurity E crude product into a solution, and filtering; 2) separating and purifying the filtered crude product solution through a chromatographic column in a preparation system, and collecting an eluent; and 3) carrying out freeze drying on the qualified eluent to obtain caspofungin acetate impurity E solid powder with the purity of 95% or above. According to the method for preparing the chromatography, isocratic and gradient elution is carried out by adopting a mixed solution of 0.1% acetic acid and acetonitrile as a mobile phase, finally, impurity E solid powder with the purity larger than 95% is obtained, the preparation method of the high-purity caspofungin acetate impurity E is provided, and the requirements of enterprises and the market can be met; and the preparation method is stable in condition, suitable for large-scale production and high in yield.

Description

technical field [0001] The invention belongs to the field of chemistry, and in particular relates to a preparation method of caspofungin acetate impurity E. Background technique [0002] Caspofungin acetate is the first echinocandin antifungal drug. It was first approved by the US Food and Drug Administration (FDA) on January 26, 2001. It is mainly used for the treatment of invasive candidiasis and other diseases. As a representative of a new class of echinocandin antibiotics, caspofungin acetate has the potential to treat ineffective or intolerable invasive aspergillosis and empirical treatment of neutropenia and suspected fungal infections in patients with fever. It has obvious advantages in high selectivity, good antibacterial activity, high safety, and less drug resistance. [0003] Caspofungin acetate is firstly fermented by Glarea Lozoyensis to obtain the fermentation product, and then the fermented product undergoes solid-liquid separation, leaching, adsorption analy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K19/00C07K1/36C07K1/34C07K1/20
CPCC07K7/56C07K2319/00
Inventor 周陈锋施林峰张军伟杜明镜王丽敏谢厅
Owner HANGZHOU ZHONGMEI HUADONG PHARMA
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