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Preparation process of high-quality sodium monosialotetrahexosylganglioside

A technology of sodium ganglioside and monosialic acid, which is applied in the preparation of sugar derivatives, sugar derivatives, sugar derivatives, etc., can solve the problems of low adverse reaction rate, inability to effectively remove heat source substances and protein substances, etc. high purity effect

Inactive Publication Date: 2018-11-16
海南益尔生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the preparation method of high-purity monosialotetrahexosylganglioside sodium disclosed in Chinese patent, application number: 201210354967.0, application date: 2012.09.24, the extraction steps of the method include the step of preparing acetone powder and the extraction of total tissue fat step, folch distribution step, devirus step and acid hydrolysis virus inactivation step; purification steps include desalting step, silica gel chromatography step, reverse phase chromatography step, concentration step, acetone recrystallization step and lyophilization step, using this method to extract The monosialotetrahexosyl ganglioside sodium has high purity and low adverse reaction rate, but it is still unable to effectively remove pyrogen substances and protein substances that cause allergic reactions in monosialotetrahexosyl ganglioside sodium

Method used

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Examples

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Effect test

Embodiment 1

[0017] 1. A preparation process for high-quality monosialotetrahexosyl ganglioside sodium, the method comprising the following steps:

[0018] Step A: the step of extracting the crude extract of pig brain; the step of extracting the crude extract of pig brain comprises the following steps:

[0019] A1: Extraction step: add the minced fresh pig brain and the extract solution into the extraction tank, the mass concentration ratio of the fresh pig brain and the extract solution is 1:3, stir for 20 minutes, let stand for 30 minutes, and then Pressure filtration, after the pressure filtration is completed, the supernatant and the filtrate are collected, the extract includes chloroform and methanol, and the ratio of the chloroform and methanol is 1:1;

[0020] A2: Stratification step: add the filtrate collected in step A1 to drinking water with a volume of 20% of the filtrate, stir for 5 minutes and let stand for 10 hours, collect the supernatant after stratification;

[0021] A3: ...

Embodiment 2

[0028] Embodiment 2: the preparation process of high-quality monosialotetrahexosyl ganglioside sodium, the method comprises the following steps:

[0029] Step A: the step of extracting the crude extract of pig brain; the step of extracting the crude extract of pig brain comprises the following steps:

[0030] A1: Extraction step: add the minced fresh pig brain and the extract solution into the extraction tank, the mass concentration ratio of the fresh pig brain and the extract solution is 1:5, stir for 30 minutes, let stand for 40 minutes, and then Pressure filtration, after the pressure filtration is completed, the supernatant and the filtrate are collected, the extract includes chloroform and methanol, and the ratio of the chloroform and methanol is 1:3;

[0031] A2: Stratification step: add the filtrate collected in step A1 to drinking water with 30% of the filtrate volume, stir for 15 minutes and then let it stand for 15 hours, and collect the supernatant after stratificat...

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PUM

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Abstract

The invention relates to the field of drug preparation and in particular relates to a preparation process of high-quality sodium monosialotetrahexosylganglioside. The preparation process comprises a pig brain crude extraction step, a silica gel chromatographic purification step, an activated carbon filtration step and an anion resin chromatography step, wherein the pig brain crude extraction stepcomprises an extraction step, a layering step, a saponification step, a resin chromatography step and a concentration, filtration and drying step. Sodium monosialotetrahexosylganglioside prepared by applying the process is high in purity, heat source substances can be effectively removed by activated carbon treatment, and protein substances capable of resulting in allergy can be effectively removed by anion resin chromatography, so that the purity can be further increased, and the occurrence rate of adverse reactions is obviously reduced.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a preparation process of high-quality monosialotetrahexosyl ganglioside sodium. Background technique [0002] Monosialotetrahexosyl ganglioside sodium is a substance that is extracted from pig brain and has an effect on nerve cell function damage. The preparation method of monosialotetrahexosyl ganglioside sodium is generally divided into extraction and extraction. Purified in two steps. For example, the preparation method of high-purity monosialotetrahexosylganglioside sodium disclosed in Chinese patent, application number: 201210354967.0, application date: 2012.09.24, the extraction steps of the method include the step of preparing acetone powder and the extraction of total tissue fat step, folch distribution step, devirus step and acid hydrolysis virus inactivation step; purification steps include desalting step, silica gel chromatography step, reverse phase chromatography...

Claims

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Application Information

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IPC IPC(8): C07H1/08C07H15/10
CPCC07H1/08C07H15/10
Inventor 陈雷楚秋平谢智远
Owner 海南益尔生物制药有限公司
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