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Preparation method for monosialotetrahexosyl ganglioside and monosialotetrahexosyl ganglioside sodium injection or freeze-dried powder injection

A technology of ganglioside and monosialic acid, which is applied in the field of biological drug preparation, can solve problems such as low toxicity, and achieve the effects of increasing content, improving safety, and reducing the content of impurities

Active Publication Date: 2010-12-01
BEIJING SAISHENG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This type of solvent has certain toxicity, but it is less toxic than the first type of solvent, and it is recommended to limit its use to prevent potential adverse effects on patients

Method used

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  • Preparation method for monosialotetrahexosyl ganglioside and monosialotetrahexosyl ganglioside sodium injection or freeze-dried powder injection
  • Preparation method for monosialotetrahexosyl ganglioside and monosialotetrahexosyl ganglioside sodium injection or freeze-dried powder injection
  • Preparation method for monosialotetrahexosyl ganglioside and monosialotetrahexosyl ganglioside sodium injection or freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Take pig brain tissue, weigh it after removing impurities, add the same amount of purified water to prepare homogenate, add 2 times the amount (V / V) of 2% Triton X-100 solution to the homogenate, stir and extract at 4-20°C for 15 hours, and centrifuge to remove Precipitation, the precipitation was extracted once again with 2% Triton X-100 solution of 2 times the amount (W / W), the extraction time was 5 hours, the extracts were combined, concentrated with an ultrafiltration membrane with a molecular weight cut-off of 10KD, and concentrated to the original volume About one-fifth of the ganglioside crude extract was obtained. Calculated by the amount of sialic acid, the content of ganglioside is 0.83mg / ml.

Embodiment 2

[0059] Take the bovine brain tissue, weigh it after removing impurities, add an equal amount of purified water to prepare a homogenate, use 1 times the amount (V / V) of 5% Tween-80 solution for the homogenate, stir and extract at 40°C for 10 hours, filter to remove the precipitate, The precipitate was extracted once again with 1 times the amount (W / W) of 5% Tween-80 solution, and the extraction time was 4 hours. The extracts were combined and concentrated under reduced pressure to about one-eighth of the original volume to obtain crude gangliosides. Extraction. Calculated by the amount of sialic acid, the content of ganglioside is 3.02mg / ml.

Embodiment 3

[0061] Take the pig brain tissue, weigh it after removing impurities, add the same amount of purified water to prepare homogenate, use 4 times the volume (V / V) of 1% Brij35 solution for the homogenate, stir and extract at 60°C for 4 hours, and centrifuge to remove the precipitate, precipitate Extract again 2 times with 1% Brij35 solution of 2 times the amount (W / W), the extraction time is 2 hours and 1 hour respectively, the combined extracts are concentrated with an ultrafiltration membrane with a molecular weight cut-off of 10KD, to four times the original volume. About one-third, to obtain the crude extract of gangliosides. Calculated by the amount of sialic acid, the content of ganglioside is 0.31mg / ml.

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Abstract

The invention provides a preparation method for monosialotetrahexosyl ganglioside. The method comprises the following steps of: 1) weighing animal brain tissues, stirring and extracting by taking aqueous solution of a detergent as an extraction solvent and removing precipitate to obtain extract; and 2) concentrating the extract to obtain monosialotetrahexosyl ganglioside crude extract. The invention also provides a preparation comprising monosialotetrahexosyl ganglioside sodium. The preparation has the advantages of no use of organic solvent during the extraction of the monosialotetrahexosyl ganglioside, simple preparation process, suitability for batch production, environmental friendliness and capability of reducing the production cost and the production period. The invention also provides a monosialotetrahexosyl ganglioside injection prepared by the method; and the injection has high purity, does not contain an organic solvent and can improve the safety of clinical administration.

Description

technical field [0001] The invention relates to a preparation method of biological medicine, in particular to a preparation method of ganglioside sodium. [0002] The present invention also relates to preparations comprising the ganglioside sodium. Background technique [0003] Gangliosides (GLS), also known as substance N, are membrane glycolipids with a complex structure containing sialic acid residues, one of the main lipid components of nerve cell membranes, and the main source of negative charges on the cell surface. recognition and signaling. [0004] Ganglioside is a special substance that promotes the repair of the central nervous system (CNS) after injury. It plays an important role in the occurrence, growth and differentiation of the nervous system. It can promote nerve cell regeneration, axon growth and Synapse formation, recovery of innervation function; improvement of nerve conduction, promotion of brain electrical activity and the recovery of other neurophysi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H15/10C07H1/08A61K31/7032A61K9/08A61K9/19A61P25/28
Inventor 马骉姜桂荣宋梦薇王天燕
Owner BEIJING SAISHENG PHARMA
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