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Preparation method and compound preparation of clavulanate potassium

A technology of potassium clavulanate and potassium carbonate, which is applied in the field of medicine, can solve the problems that small molecular protein pigments and sugar components cannot be effectively removed, affect the separation of clavulanic acid, salt formation, and expensive extraction equipment, etc., so as to reduce emulsification , prevent the increase of process difficulty and cost, and reduce the effect of production cost

Inactive Publication Date: 2015-09-16
高希章 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The applicant (including the completer of the Science and Technology Progress Award) found in the actual application process that there will still be a small amount of small molecular protein, pigment and sugar components that cannot be effectively removed in the subsequent process, and sometimes emulsification will occur, which will affect the clavier Subsequent operations such as acid separation and salt formation; and there is also the problem of expensive extraction equipment

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] (1) The fermented broth of Streptomyces clavulatus LNSC-2 is filtered through 0.45 μm membrane micropores successively, polysulfone membrane (molecular cut-off is 10-200 kilodaltons), aramid composite membrane (molecular cut-off is 10 -1000 Daltons);

[0021] (2) After the filtrate is decolorized by adding activated carbon, add 3 times the volume of ethyl acetate, transfer it to and fill it with a pressure-resistant container, remove air bubbles, seal and shake, freeze at -18°C until the water phase is partially frozen, take it out, and remove the water phase , to obtain the extract;

[0022] (3) Add an equal volume of 50% potassium carbonate solution (m / v) to the stirring solution of the extract, transfer it to and fill it with a pressure-resistant container, seal and vibrate after removing air bubbles, take it out after freezing at -18°C for 8 hours, and remove the organic phase, after the solid melts, slowly add acetone dropwise at 0-5°C, stir slowly for 1 hour, fil...

Embodiment 2

[0024] (1) The fermented broth of Streptomyces clavulatus LNSC-2 is filtered through 0.45 μm membrane micropores successively, polysulfone membrane (molecular cut-off is 10-200 kilodaltons), aramid composite membrane (molecular cut-off is 10 -1000 Daltons);

[0025] (2) After adding activated carbon to the filtrate for decolorization, add 3 times the volume of chloroform, transfer to and fill the pressure-resistant container, remove air bubbles, seal and oscillate, freeze at -18°C until the water phase is partially frozen, take it out, remove the water phase, and obtain Extract;

[0026] (3) Add an equal volume of 40% potassium carbonate solution (m / v) to the extract while stirring, transfer it to a pressure-resistant container, remove air bubbles, seal and oscillate, freeze at -18°C for 8 hours, take it out, and layer , remove the organic phase, after the solid melts, slowly add acetone dropwise at 0-5°C, stir slowly for 1 hour, filter, wash with acetone, and dry under vacuu...

Embodiment 3

[0028] (1) The fermented broth of Streptomyces clavulatus LNSC-2 is filtered through 0.45 μm membrane micropores successively, polysulfone membrane (molecular cut-off is 10-200 kilodaltons), aramid composite membrane (molecular cut-off is 10 -1000 Daltons);

[0029] (2) After the filtrate is decolorized by adding activated carbon, add 3 times the volume of ethyl acetate, transfer it to and fill it with a pressure-resistant container, remove air bubbles, seal and shake, freeze at -18°C until the water phase is partially frozen, take it out, and remove the water phase , to obtain the extract;

[0030] (3) Add an equal volume of 60% potassium carbonate solution (m / v) to the stirring solution of the extract, transfer it to and fill it with a pressure-resistant container, seal and vibrate after removing air bubbles, freeze at -18°C for 3 hours, take it out, and remove the organic phase, after the solid melts, slowly add acetone dropwise at 0-5°C, stir slowly for 1 hour, filter, wa...

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PUM

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Abstract

The present invention discloses a preparation method and a compound preparation of clavulanate potassium. The preparation method comprises: filtering a Streptomyces clavuligerus fermentation sequentially with a microporous filtration membrane, a polysulfone membrane and an aromatic polyamide composite membrane; adding active carbon to the filtrate to decolorize, adding an extractant, transferring and filling into a pressure resistance container, removing gas bubbles, carrying out sealed oscillation, carrying out temperature control freezing until the water phase is frozen, taking out, and removing the water phase to obtain an extraction liquid; stirring the extraction liquid while adding a potassium carbonate solution, transferring and filling into a pressure resistance container, removing gas bubbles, carrying out sealed oscillation, carrying out temperature control freezing, taking out, removing the organic phase, slowly adding acetone in a dropwise manner after the solid melts, slowly stirring, filtering, washing with acetone, and carrying out vacuum drying to obtain clavulanate potassium; and carrying out sterile mixing on clavulanate potassium and amoxicillin according to a weight ratio of 1:5 or on clavulanate potassium and ticarcillin according to a ratio of 1:15-30. According to the present invention, the preparation method has characteristics of simple process and low cost, and the prepared product has characteristics of low impurity content and high purity.

Description

technical field [0001] The invention relates to a preparation method of potassium clavulanate and a compound preparation thereof, belonging to the field of medicine. Background technique [0002] Potassium clavulanate, chemical name: (Z)-(2S,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo-3.2.0-heptane Potassium alkane-2-carboxylate has only weak antibacterial activity, but it can be firmly combined with most β-lactamases to form irreversible conjugates. It has a strong and broad-spectrum inhibitory effect on β-lactamases. It not only acts on the enzymes of Staphylococcus, but also acts on the enzymes produced by a variety of Gram-negative bacteria, so it is an effective β-lactamase inhibitor. [0003] Through the genetic engineering transformation of clavulanic acid-producing bacteria to screen out high-yield genetically engineered strains, the control optimization of the fermentation process, and the development of a series of compound preparations and other innovati...

Claims

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Application Information

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IPC IPC(8): C07D503/18C07D503/02A61K31/431A61K31/424
CPCC07D503/02A61K31/424A61K31/431C07D503/18A61K2300/00
Inventor 高希章蒋晨黄涛陈宇东
Owner 高希章
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