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Purification method for erythromycin thiocyanate

A technology of erythromycin thiocyanate and a purification method, which is applied in the field of biopharmaceuticals to achieve the effects of improved fermentation level, strong process adaptability, and quality improvement

Active Publication Date: 2021-07-23
HEC PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a purification method of erythromycin thiocyanate, which solves the deficiency of the existing water-adding dissolution process and provides a new method for preparing high-purity erythromycin thiocyanate product

Method used

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  • Purification method for erythromycin thiocyanate
  • Purification method for erythromycin thiocyanate
  • Purification method for erythromycin thiocyanate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A purification method of erythromycin thiocyanate, said method comprising the following steps:

[0032] 1.1 Crude erythromycin thiocyanate was dissolved and phase-separated

[0033] Accurately weigh 500g of crude product erythromycin thiocyanate, measure 1650ml of butyl acetate by material ratio crude product erythromycin thiocyanate (g): butyl acetate (ml)=1:3.3, transfer butyl acetate to glass After the beaker (specification 3000ml), start stirring, add crude product erythromycin thiocyanate, heat up after adding, when the temperature of the system rises to 45°C, start to add NaOH solution with a mass concentration of 5%, and control the pH of the system to 10.4 until complete Dissolve, keep warm and stand still, separate the phases, and collect the upper layer of butyl acetate phase material.

[0034] 1.2 Add crystallization aids to crystallize

[0035] Preparation of crystallization aid: 40 g of solid NaSCN (1.25 mol equivalent) was added to 330 ml of H 2 In O (2...

Embodiment 2

[0044] A purification method of erythromycin thiocyanate, said method comprising the following steps:

[0045] 2.1 Crude erythromycin thiocyanate dissolved and phase separated

[0046] Accurately weigh crude product erythromycin thiocyanate 2000g, measure butyl acetate 6600ml by material ratio crude product erythromycin thiocyanate (g): butyl acetate (ml)=1:3.3, transfer butyl acetate to glass After the dissolving tank (10000ml in size), start stirring, add crude product erythromycin thiocyanate, heat up after adding, when the temperature of the system rises to 45°C, start to add NaOH solution with a mass concentration of 5%, and control the pH of the system to 11 until Dissolve completely, keep warm and stand still, separate the phases, and collect the upper butyl acetate phase material.

[0047] 2.2 Crystallization by feeding crystallization aids

[0048] Preparation of crystallization aids: 190 g of solid NaSCN (1.49 mol equivalent) was added to 1320 ml of H 2In O (20% b...

Embodiment 3

[0057] A purification method of erythromycin thiocyanate, said method comprising the following steps:

[0058] 3.1 Crude erythromycin thiocyanate dissolution and phase separation

[0059] Accurately weigh 36Kg of crude product erythromycin thiocyanate, measure 144L of butyl acetate by material ratio crude product erythromycin thiocyanate (g): butyl acetate (ml)=1:4, transfer butyl acetate to enamel After the glass dissolution tank (specification 250L), start stirring, add crude erythromycin thiocyanate, heat up after adding, when the system temperature rises to 40°C, start to add NaOH solution with a mass concentration of 10%, and control the pH of the system to 10 Until it is completely dissolved, keep it warm and stand still, separate the phases, and collect the upper layer of butyl acetate phase material.

[0060] 3.2 Crystallization by feeding crystallization aids

[0061] Preparation of crystallization aid: 2919g solid NaSCN (1.3mol equivalent) was added to 36LH 2 In O...

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Abstract

The invention provides a purification method for erythromycin thiocyanate. The method comprises the following specific steps of S1, adding an erythromycin thiocyanate crude product into a butyl acetate solvent, performing heating to 40-50 DEG C, then adjusting the pH value to 10-11, performing heat preservation and phase separation after complete dissolution, and collecting a butyl acetate phase solution; and S2, performing heat preservation on the butyl acetate phase solution, adding methanol into the butyl acetate phase solution, adding a crystallization auxiliary agent into a system after uniformly stirring, growing crystals after material adding, then performing cooling and growing crystals again, and finally, drying the separated crystals to obtain an erythromycin thiocyanate product. According to the method, by adjusting a CH3OH consumption, impurity components such as an erythromycin B component are removed, the erythromycin component content is increased, and the provided preparation method for crystallizing the erythromycin thiocyanate under a new solvent system has characteristics of simple process, easy control and effective impurity removal.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a method for purifying erythromycin thiocyanate. Background technique [0002] Erythromycin is an antibiotic isolated from the culture medium of Saccharopolyspora ruberosa in 1952. Later, erythromycin A, B, C, D, E and other components were isolated from the fermentation broth, among which erythromycin Factor A is the main component, which has strong antibacterial activity and less toxic and side effects, while other components have weak antibacterial activity and greater toxic and side effects than A. Therefore, the current extraction and purification process of erythromycin focuses on increasing the content of the product erythromycin A component and reducing the content of the internal impurities in the erythromycin B component. Erythromycin thiocyanate is an intermediate of the macrolide antibiotic erythromycin. This product is generally used as a pharmaceutical intermediat...

Claims

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Application Information

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IPC IPC(8): C07H1/06C07H17/08
CPCC07H1/06C07H17/08
Inventor 邹兵商清海邓肇政熊辉
Owner HEC PHARM
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