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Refining method capable of improving purity of monosialotetrahexosyl ganglioside sodium product

A technology of ganglioside sodium and monosialic acid, which is applied in the preparation of sugar derivatives, chemical instruments and methods, sugar derivatives, etc., can solve the problems of insufficient extraction technology, achieve less impurities, high solid purity, and fine high degree of effect

Inactive Publication Date: 2017-07-28
四川奇格曼药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because it is derived from pig brain, the current extraction technology is not fine enough, and the extracted monosialotetrahexosylganglioside sodium will also contain traces of harmful substances and impurities, which requires further refining of the finished product to achieve Requirements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for refining monosialotetrahexosylganglioside sodium finished product, comprising the following steps:

[0026] (1) Treatment of cation resin: Wash the cation exchange resin with purified water, filter it dry with gauze, then wash it with analytical pure NaOH and HCl, then wash it with purified water, and filter it dry to obtain a cation exchange resin for purification;

[0027] (2) Dissolve the sample (the finished product of monosialotetrahexosylganglioside sodium): dissolve the sample in pure water to obtain a sample solution, put the above-mentioned cation exchange resin for purification and the sample solution into the chromatographic column to obtain a cation resin column , carry out resin chromatography, obtain slurry;

[0028] (3) Precipitation and filtration of acetone: Accurately measure acetone according to the weight of the slurry: acetone (W:V) = 1:10, stir the acetone and the slurry evenly, and settle at low temperature for no less than 5 hours; t...

Embodiment 2

[0032] In this example, on the basis of Example 1, the steps of resin chromatography in the step (2) are:

[0033] (2.1) The dissolved sample passes through the cationic resin column at a flow rate of 100L / h. After the sample is loaded, it is washed with purified water; after the sample is loaded, the sample is collected in 0.5 column volume, 50L / barrel, and the purified water is washed for 0.5 column volume and ends sample collection;

[0034] (2.2) Collect samples and adjust the pH value to 6.0-6.5 (adjust with saturated NaOH solution and 5mol / L Hcl solution);

[0035] (2.3) After adjusting the pH, the sample is first filtered with a 0.45 μm mixed fiber membrane, and then filtered with a 0.22 μm mixed fiber membrane;

[0036] Other parts of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

Embodiment 3

[0038] In this embodiment, on the basis of the above embodiments, the step (3) also includes the reprocessing of the solid after suction filtration: Accurately measure acetone according to the solid weight: acetone (W: V ) = 1:3, and Pour into the solid, stir and mix, let it stand for 10 minutes, then use a suction filter to filter to dryness, and transfer the filtrate to the acetone storage tank to be recovered.

[0039] The other parts of this embodiment are the same as those of the above embodiment, and will not be repeated here.

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PUM

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Abstract

The invention discloses a refining method capable of improving purity of monosialotetrahexosyl ganglioside sodium product. The refining method includes: treating cation resin; dissolving a sample (the monosialotetrahexosyl ganglioside sodium product); precipitating and filtering acetone; drying, and packaging. Through cation exchange resin after going through purification treatment, a prepared cation resin column has better chromatography effect, and size after chromatography is enabled to be higher in purity further; through several times of suction filtering of acetone and the size, solid obtained after suction filtering is higher in purity and fewer in impurity; through sieving the solid after being crushed through a screen, obtained powder is higher in fineness, more uniform in size specification and better in color presentation.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a refining method for improving the purity of monosialotetrahexosylganglioside sodium finished product. Background technique [0002] Sodium monosialotetrahexosyl ganglioside is a substance that is extracted from pig brain and has an effect on nerve cell function damage. The prior art has carried out a large amount of research on the extraction of monosialotetrahexosyl ganglioside sodium based on improving product purity, yield, reducing product cost, reducing the usage of toxic organic solvents, etc., and the market already has Monosialotetrahexosylganglioside Sodium Injection, Monosialotetrahexosylganglioside Sodium Injection and other products are on sale and used. However, because it is derived from pig brain, the current extraction technology is not fine enough, and the extracted monosialotetrahexosylganglioside sodium will also contain traces of harmful substances and i...

Claims

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Application Information

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IPC IPC(8): C07H15/10C07H1/06
CPCC07H1/06C07H15/10
Inventor 张宪胡伟杨琴飞
Owner 四川奇格曼药业有限公司