Monosialotetrahexosylganglioside sodium preparation and preparation method thereof

A technology of sodium ganglioside and monosialic acid, which is used in nervous system diseases, pharmaceutical formulations, medical preparations containing active ingredients, etc. problems, to achieve the effects of convenient clinical use, avoidance of secondary pollution, and simple storage conditions

Inactive Publication Date: 2015-03-04
长春翔通药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the commercially available GM1 pharmaceutical preparations are injections (i.e. small needles), generally packaged as 2ml or 5ml per bottle, and the main drug is the sodium salt of monosialotetrahexosylganglioside, but these GM1 preparations The stability of the main drug is not good enough, the liquid is turbid and the clarity is not high, and there are certain safety hazards in the process of use by patients
In addition, the injection needs to be compatible with sodium chloride or glucose injection before use, which is not conducive to the use of acute patients, and it is easy to cause secondary pollution during the compatibility process, such as particle pollution and microbial pollution caused by frequent needle punctures.

Method used

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  • Monosialotetrahexosylganglioside sodium preparation and preparation method thereof
  • Monosialotetrahexosylganglioside sodium preparation and preparation method thereof
  • Monosialotetrahexosylganglioside sodium preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0020] Example 1 Preparation 1 (pH7.42):

[0021] Name of raw material

[0022] Co-made

[0023] Preparation process: Weigh monosialotetrahexosyl ganglioside sodium, disodium hydrogen phosphate (anhydrous), sodium dihydrogen phosphate (anhydrous) and sodium chloride in the prescribed amount, add about 95% of the total volume Dissolve in water for injection, add water for injection to full volume. Filter through a 0.22 μm microporous membrane, fill in a 50ml low-borosilicate soda-lime glass bottle, melt seal, and sterilize by autoclaving at 121°C for 15 minutes.

Embodiment 2

[0024] Example 2 Preparation 2 (pH7.48):

[0025] Name of raw material

[0026] Preparation process: Weigh monosialotetrahexosyl ganglioside sodium, disodium hydrogen phosphate (anhydrous), sodium dihydrogen phosphate (anhydrous) and sodium chloride in the prescribed amount, add about 95% of the total volume Dissolve in water for injection, add water for injection to full volume. Filter through a 0.22 μm microporous membrane, fill in a 50ml low-borosilicate soda-lime glass bottle, melt seal, and sterilize by autoclaving at 121°C for 15 minutes.

Embodiment 3

[0027] Example 3 Preparation three (pH7.55):

[0028] Name of raw material

[0029] Preparation process: Weigh monosialotetrahexosyl ganglioside sodium, disodium hydrogen phosphate (anhydrous), sodium dihydrogen phosphate (anhydrous) and sodium chloride in the prescribed amount, add about 95% of the total volume Dissolve in water for injection, add water for injection to full volume. Filter through a 0.22 μm microporous membrane, fill in a 100ml low borosilicate soda calcium glass bottle, melt seal, and sterilize by autoclaving at 121°C for 15 minutes.

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Abstract

The present invention relates to a safe and stable monosialotetrahexosylganglioside sodium preparation, which is an infusion, wherein per 1 ml of water for injection contains less than 5 g of the monosialotetrahexosylganglioside sodium. The monosialotetrahexosylganglioside sodium preparation has characteristics of high clarity, good main drug solubility, high stability, no safety risk during a use process, simple storage condition, easy long-term storage, convenient clinical use, secondary pollution avoiding, and substantially convent acute patient use.

Description

technical field [0001] The invention relates to a nerve remodeling drug, in particular to a safe and stable monosialotetrahexosyl ganglioside sodium preparation and an application thereof. Background technique [0002] Gangliosides are sialic acid-containing glycosphingolipids that exist in mammalian cell membranes, especially in the nervous system. They are components of nerve cell membranes and are essential in the process of neurogenesis, growth, and differentiation. It is also very important for nerve repair after injury. It can promote nerve regeneration, promote nerve axon growth and synapse formation, restore innervation function; improve nerve conduction, promote the recovery of brain electrical activity and other neurophysiological indicators; Protect the cell membrane, promote the recovery of various enzyme activities of the cell membrane, etc. [0003] Sodium monosialotetrahexosyl ganglioside (GM1) is one of the most important gangliosides and plays an important ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/7032A61K47/02A61P25/16A61P25/28
Inventor 祝国华王楠
Owner 长春翔通药业有限公司
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