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Metadoxine injection and preparation method thereof

A technology of Xin injection and metadoxine, which is applied in the directions of antidote, pharmaceutical formulation, drug delivery, etc., can solve the problems of high light transmittance of the container, no human clinical research verification, drug degradation, etc., and achieves a simple preparation process, Low cost and the effect of preventing photolysis

Inactive Publication Date: 2012-11-21
武陟维尔康生化制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the dosage forms of metadoxine include tablets, freeze-dried powder injections, etc. There are defects such as not using a brown container, the container has a high light transmittance, visible light is easy to cause drug degradation, and human clinical research has not been verified.

Method used

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  • Metadoxine injection and preparation method thereof
  • Metadoxine injection and preparation method thereof
  • Metadoxine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1 prepares a kind of metadoxine injection

[0019] The party is:

[0020]

[0021] The purity of metadoxine used was 99.0%.

[0022] The preparation method is: first dissolve 5g of cysteine ​​hydrochloride and 1g of disodium ethylenediaminetetraacetic acid in 4000ml of water for injection in the liquid mixing tank in turn, stir and mix evenly, heat up to 50°C, add metatars Doxin 300g, stir well until it is completely dissolved, add water to the full volume of 5000ml, add 0.5% activated carbon for decolorization and depyrogenation, keep it at 45°C for 30 minutes, decarbonize, and filter the solution through 0.45μm and 0.22μm filters for sterile filtration , filled with inert gas N 2 , and filled into brown light-proof ampoules, leak detection after sealing, and light inspection for packaging. The whole process is fully aseptic. During the whole process of filtration and filling, it is filled with inert gas nitrogen for protection.

[0023] The light tr...

Embodiment 2

[0024] Embodiment 2 prepares a kind of metadoxine injection

[0025] The party is:

[0026]

[0027] The purity of metadoxine used was 99.0%.

[0028] The preparation method is as follows: first dissolve 2g of low-molecular dextran, 2g of disodium ethylenediaminetetraacetic acid, and 1g of sodium chloride in 4000ml of water for injection in a liquid mixing tank, stir and mix evenly, and then heat up to 50°C. Add 320g of metadoxine, stir well until it is completely dissolved, add water to the full volume of 5000ml, add 0.5% activated carbon for decolorization and depyrogenation, keep it at 40°C for 30 minutes, decarbonize, and filter the solution through 0.45μm and 0.22μm filters Sterile filtration, filled with inert gas N 2 , and filled into brown light-proof ampoules, leak detection after sealing, and light inspection for packaging. The whole process is fully aseptic. During the whole process of filtration and filling, it is filled with inert gas nitrogen for protectio...

Embodiment 3

[0030] Embodiment 3 prepares a kind of metadoxine injection

[0031] The party is:

[0032]

[0033] The purity of metadoxine used was 99.0%.

[0034] The preparation method is as follows: first dissolve 2 g of sodium metabisulfite and 1 g of disodium ethylenediamine tetraacetate in 4000 ml of water for injection in a liquid mixing tank, stir and mix evenly, heat up to 50°C, add 300 g of metadoxine, and fully Stir until it is completely dissolved, add water to the full volume of 5000ml, add 0.5% activated carbon to decolorize and remove pyrogens, keep it at 50°C for 30 minutes, decarbonize, filter the solution through 0.45μm and 0.22μm filters, and fill it with inert gas N 2 , and filled into brown light-proof ampoules, leak detection after sealing, and light inspection for packaging. The whole process is fully aseptic. During the whole process of filtration and filling, it is filled with inert gas nitrogen for protection.

[0035] The light transmittance (660nm wavele...

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Abstract

The invention discloses a metadoxine injection, which is prepared from the following raw materials: metadoxine with the concentration being 2-100g / L, pharmaceutic adjuvants with the concentration being 0.2-10g / L, and water for injection / ethanol for injection. A preparation method comprises the following steps of: adding the pharmaceutic adjuvants into the water for injection / ethanol for injection, after stirring and dissolving, heating to rise the temperature to be 30-60 DEG C, adding the metadoxine, and adding the water for injection / ethanol for injection to be constant volume; and adding activated carbon, which is 0.5 percent of the total mass of solution, for decoloration and depyrogenation, staying warm at the temperature of 40-50 DEG C, standing for 15-30 minutes, decarburizing, carrying out aseptic filtration on the solution through a 0.45 mum filter and a 0.22 mum filter, and after filtration, filling into a brown lucifugal ampoule filled with nitrogen so as to obtain the metadoxine injection. The metadoxine injection is in a form of a small volume injection or infusion solution, the half-life period is 3.00 hours, the AUC0-t is 1.95g / L*h, and the advantages of fast onset of action, quick effect, high bioavailability and the like are realized.

Description

technical field [0001] The invention relates to a metadoxine injection and a preparation method thereof. Background technique [0002] Metadoxine Injection is mainly used clinically for the treatment of acute and chronic alcoholism and alcoholic fatty liver. It is also considered to be effective in abstaining from alcohol, reducing dependence on alcohol, and improving memory function, especially short-term memory. This product is an aldehyde dehydrogenase activator, which can significantly increase the activity of acetaldehyde dehydrogenase. Experiments have proved that in the presence of this product, the speed of acetaldehyde metabolism and conversion into acetate is significantly accelerated, and it can reduce the formation of long-acting macromolecular complexes with cytotoxic activity caused by the interaction between albumin and acetaldehyde, and improve Hepatic ATP concentration, speed up the transport of amino acids in cells, antagonize the inhibitory effect of etha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4415A61P1/16A61P25/32A61P39/02
Inventor 刘盛儒王增鑫隗青孙岩王基伟张梅村陆晓惠
Owner 武陟维尔康生化制药有限公司