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Method for removing histamine in dalbavancin intermediate A-40926B0

A technology of A-40926B0 and dalbavancin, applied in the field of medicinal chemistry, can solve the problems of poor specificity of histamine, excessive histamine residue, easy adsorption, etc., to reduce production costs, improve production quality, and reduce operating costs Effect

Pending Publication Date: 2021-09-28
CHONGQING QIANTAI BIOLOGICAL MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are many detection methods for histamine in China, but there are few reports on methods for removing histamine
In 2005, Wu Lihui used activated carbon to remove histamine in ribomycin sulfate injection (improvement of ribomycin sulfate aseptic spray process [J]. Fujian Chemical Industry, 2005, (4): 25-26.) But this method removes histamine The specificity of amine is not strong, it is easy to adsorb other effective components of drugs, and activated carbon cannot be recycled and reused
[0005] CN103060405B discloses a microbial fermentation method to prepare A-40926B 0 The method uses fish meal peptone as the fermentation raw material to produce the raw material drug of dalbavancin, and there is a risk of excessive histamine residues

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] This embodiment removes dalbavancin intermediate A-40926B 0 The method for middle histamine, comprises the following steps:

[0034] 1) For A-40926B 0 The fermentation broth is pretreated, specifically adjusting the pH of the fermentation broth to 11.0 with a NaOH solution with a mass fraction of 30%, then adding industrial ethanol with 1 times the volume of the fermentation broth and stirring for 1 hour, vacuum filtering, and concentrating the filtrate under reduced pressure to remove ethanol to obtain concentrated liquid, adjust the pH of the concentrated solution to 11.0 for later use;

[0035] 2) The concentrated solution is passed through a chromatographic column equipped with the same volume of Ni-NTAHis Bind resin as the concentrated solution (the average pore diameter of the resin microspheres is 0.5-1mm), so that the histamine in the concentrated solution is mixed with the Ni-NTAHis Bind resin Fully combined; control the temperature of the concentrated soluti...

Embodiment 2

[0038] This embodiment removes dalbavancin intermediate A-40926B 0 The method for middle histamine, comprises the following steps:

[0039]1) For A-40926B 0 The fermentation broth is pretreated, specifically adjusting the pH of the fermentation broth to 10.5 with a NaOH solution with a mass fraction of 30%, then adding industrial ethanol with 1 times the volume of the fermentation broth and stirring for 1 hour, vacuum filtration, and concentrating the filtrate under reduced pressure to remove ethanol to obtain concentrated liquid, adjust the pH of the concentrated solution to 10.5 for later use;

[0040] 2) The concentrated solution is passed through a chromatographic column equipped with the same volume of Ni-NTAHis Bind resin as the concentrated solution (the average pore diameter of the resin microspheres is 0.5-1mm), so that the histamine in the concentrated solution is mixed with the Ni-NTAHis Bind resin Fully combined; control the temperature of the concentrated soluti...

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Abstract

The invention belongs to the field of medical chemistry, and particularly relates to a method for removing histamine in a dalbavancin intermediate A-40926B0. The method for removing the histamine in the dalbavancin intermediate A-40926B0 comprises the following steps: pretreating A-40926B0 fermentation liquor, then adding ethanol, mixing, then carrying out suction filtration, and concentrating the obtained filtrate to remove the ethanol so as to obtain concentrated solution; enabling the concentrated solution to flow through a chromatographic column filled with Ni-NTA His.Bind resin, so that histamine in the concentrated solution is fully combined with the Ni-NTA His.Bind resin; and collecting the filtrate flowing through the Ni-NTA His.Bind resin, and detecting the contents of A-40926B0 and histamine in the filtrate. The yield of the A-40926B0 obtained by adopting the method disclosed by the invention reaches 99.99%, and the histamine content is only 4-5ppm, which accords with the histamine control standard of the bulk drug (API).

Description

technical field [0001] The invention belongs to the field of medicinal chemistry, in particular to a method for removing dalbavancin intermediate A-40926B 0 The method of histamine. Background technique [0002] Histamine (Histamine, HA), also known as histamine, molecular formula: C 5 h 9 N 3 , chemical name: 4(5)-(2-aminoethyl)imidazole. It is one of the autologous active substances, which is mainly stored in mast cells and basophils in the human body. When the human body is stimulated by allergens, it will release histamine, causing blood vessels to dilate, resulting in edema, lower blood pressure, various corresponding symptoms, and damage to health. As an inflammatory mediator of immediate hypersensitivity, when histamine in the blood reaches a certain level, anaphylactic shock or even death will occur. [0003] Between 2015 and 2017, there were at least 154 cases of adverse reactions in horses caused by injection of gentamicin sulfate in Europe, the main symptom ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D471/14
CPCC07D471/14
Inventor 童永亮刘省伟郭明袁建栋
Owner CHONGQING QIANTAI BIOLOGICAL MEDICINE