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Preparation of ornithine aspartate for injection

A technology for ornithine aspartate and injection, which is applied in the field of pharmaceutical preparation technology, and can solve the problems of large eluent volume, high alcohol consumption, and long process time

Inactive Publication Date: 2012-05-30
BEIJING KAWIN TECH SHARE HLDG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Chinese patent CN101798275A discloses a preparation method of ornithine aspartate. In this method, after dissolving L-ornithine acetate in water, L-aspartic acid is added, and then the pH is adjusted to 6 with ammonia. -9, activated carbon decolorization, polar organic solvent recrystallization, this method is due to directly adding polar organic solvent crystallization in the reaction solution after reaction, in industrial production, it needs to consume a large amount of organic solvent to carry out like this, and the cost is also relatively high High, and because the salt after the reaction is removed, these salts will inevitably be brought into the crystal during recrystallization
[0012] In the prior art, when preparing ornithine aspartate, or introducing ion exchange method to remove some inorganic salt impurities in the reaction, and then proceed to the crystallization step, this process takes a long time, and in the subsequent crystallization, the obtained The volume of the eluent is large, and it needs to consume a large amount of alcohol when directly adding alcohol for crystallization, and the cost is high; or if the inorganic salt ions in the reaction solution are not removed, a polar organic solvent is directly added to the reaction solution for the crystallization step, which is easy to produce in the crystallization product. Some other impurities are brought in, and because it has not been concentrated, it takes a lot of alcohol to crystallize, and the cost is also high; or after the reaction liquid is initially concentrated under reduced pressure, the concentrated liquid is then crystallized. It takes a long time and consumes a lot of energy

Method used

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  • Preparation of ornithine aspartate for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0030] Take 20kg of L-ornithine hydrochloride, add 50L of water for injection, stir while adding, then add 2kg of NaOH, stir to dissolve completely, heat to 60°C, and continue stirring for about 1 hour;

[0031] Weigh 16 kg of L-aspartic acid, add it to the above solution in portions, and stir while adding to dissolve completely, until the pH of the strip reaches 7.0-7.5, and continue to stir at about 60°C for 3 hours;

[0032]Under a sterile environment in the production control area, weigh 90 g of activated carbon powder, add it to the above-mentioned raw material reaction solution, continue heating and stirring (60 ° C) for 30 min, and filter it with a microporous membrane with a pore size of 0.22 μm while it is hot, and the filtrate is set aside;

[0033] In a sterile environment in the production control area, prepare a nanofiltration machine with a nanofiltration membrane pore size of 100 Daltons; start the machine, adjust the pump flow rate, and maintain the membrane inl...

Embodiment 2

[0036] Take 20kg of L-ornithine hydrochloride, add 50L of water for injection, stir while adding, then add 3kg of NaOH, stir to dissolve completely, heat to 60°C, and continue stirring for about 1 hour;

[0037] Weigh 24 kg of L-aspartic acid, add it to the above solution in portions, and stir while adding to dissolve completely, until the pH of the strip reaches 7.0-7.5, and continue to react at about 60°C for 2 hours;

[0038] Under a sterile environment in the production control area, weigh 450 g of activated carbon powder, add it to the above-mentioned raw material reaction solution, continue heating and stirring (60 ° C) for 30 min, and filter it while hot with a microporous membrane with a pore size of 0.22 μm, and the filtrate is set aside;

[0039] In a sterile environment in the production control area, prepare a nanofiltration machine with a nanofiltration membrane pore size of 200 Daltons; start the machine, adjust the pump flow rate, and maintain the membrane inlet ...

Embodiment 3

[0042] Take 20kg of L-ornithine hydrochloride, add 50L of water for injection, stir while adding, then add 5kg of NaOH, stir to completely dissolve, heat to 60°C, and continue stirring for about 1 hour;

[0043] Weigh 24 kg of L-aspartic acid, add it to the above solution in portions, and stir while adding to dissolve completely, until the pH of the strip reaches 7.0-7.5, and continue to react at about 60°C for 2 hours;

[0044] Under the aseptic environment of the production control area, weigh 800g of activated carbon powder, add it to the above-mentioned raw material reaction solution, continue heating and stirring (60°C) for 30min, filter it with a microporous membrane with a pore size of 0.22μm while it is hot, and use the filtrate for later use;

[0045] In a sterile environment in the production control area, prepare a nanofiltration machine with a nanofiltration membrane pore size of 150 Daltons; start the machine, adjust the pump flow rate, and maintain the membrane in...

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Abstract

The invention relates to a preparation process of ornithine aspartate for injection. According to the preparation process, a one-step operation of concentration, desalination and purification is carried out on the obtained reacted raw material liquid. The process used in the invention, which has the advantages of simplicity, short production period, and low energy consumption, is very suitable for the industrialized production of ornithine aspartate injections.

Description

technical field [0001] The invention relates to a method for preparing ornithine-aspartate for injection, in particular to a method for preparing ornithine-aspartate injection by adopting a nanofiltration method to perform one-step concentration and desalination, and belongs to the field of pharmaceutical preparation technology. Background technique [0002] Aspartic acid ornithine is a salt formed by the chemical reaction of L-aspartic acid and L-ornithine, the chemical name is (S)-2,5-diaminopentanoic acid-(S)-2- Aminosuccinate with a molecular weight of 265 Daltons. Aspartic acid ornithine can provide the substrate for the synthesis of urea and glutamine, and glutamine is the detoxification product of ammonia, and it is also the storage and transportation form of ammonia; under physiological and pathological conditions, the synthesis machine of urea Aminoamide synthesis is affected by ornithine, aspartate, and other dicarboxylic compounds. Ornithine is almost involved i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/205A61K9/14A61P1/16A61P3/00A61P25/28
Inventor 熊国裕
Owner BEIJING KAWIN TECH SHARE HLDG
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