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Method for preparing ornithine aspartate powder injection for injection

The technology of aspartate ornithine aspartate powder injection and aspartate ornithine aspartate is applied in the field of medicine and can solve the problems of long freeze-drying time, high production cost, easy precipitation of crystals, etc. The effect of short cycle time and low production cost

Inactive Publication Date: 2010-09-29
HUBEI HOPE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] 1. The common specification of the existing aspartic acid ornithine aqueous injection is 10ml:5g. Due to the high concentration, it is easy to precipitate crystals under low temperature conditions, which is not conducive to clinical use.
[0017] 2. The existing aspartic acid ornithine freeze-dried powder injection (injection), due to its large size, requires special vials during the freeze-drying process to prevent a large number of vials from breaking during the freeze-drying process
Even so, the product specification can only reach 2.5g / bottle, which is extremely inconvenient for clinical use (clinical use is 10-20g each time)
Simultaneously because the freeze-drying time is longer, it generally takes 3 to 4 days to complete a production cycle (in actual production, the freeze-drying amount of general freeze-dried products is less than 0.5g / bottle, and the freeze-drying time is about one day), so the production cost is relatively high. High, not conducive to mass production

Method used

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  • Method for preparing ornithine aspartate powder injection for injection

Examples

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Comparison scheme
Effect test

Embodiment 1

[0033] A preparation method of aspartic acid ornithine powder injection for injection, the method comprises the following steps:

[0034] 1. Take 4.5kg of barium hydroxide, add 30L of water to heat and stir to dissolve completely, then add 3.5kg of arginine, heat to 90 or 93 or 95 or 98 or 100°C, continue stirring to hydrolyze arginine, use thin The termination of the reaction was monitored by layer chromatography, once every half an hour, and when no arginine spots were detected, the reaction was carried out for another half an hour to ensure that there was no arginine residue in the reaction solution.

[0035]2, gradually add 50% sulfuric acid solution 2.7kg and aspartic acid 2.7kg in step 1 reaction solution under agitation, and continue to adjust the pH of the solution with 50% sulfuric acid solution to be neutral (about 6.5) and then After no barium sulfate precipitate occurs, continue to stir for 2 hours, filter, and remove the barium sulfate precipitate and unreacted as...

Embodiment 2

[0041] A preparation method of aspartic acid ornithine powder injection for injection, the method comprises the following steps:

[0042] 1. Take 4.5kg Ba(OH) 2 .8H 2 O, add 30L of water, heat and stir to dissolve completely, then add 3.5kg of arginine, heat to 91 or 92 or 94 or 97 or 99°C, continue stirring to hydrolyze the arginine, monitor the termination of the reaction by thin-layer chromatography, Once every half an hour, when no arginine spots can be detected, react for another half an hour to ensure that there is no arginine residue in the reaction solution.

[0043] 2. Gradually add 75% phosphoric acid solution 1.2kg and aspartic acid 2.7kg to step 1 reaction solution under agitation, and continue to adjust the pH of the solution with 75% phosphoric acid solution to be neutral (about 6.5) and then After no barium phosphate precipitate occurs, continue stirring for 2 hours and filter to remove the barium phosphate precipitate and unreacted aspartic acid.

[0044] 3....

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Abstract

The invention discloses a method for preparing ornithine aspartate powder injection for injection. The method comprises the following steps of: taking arginine, adding the solution of barium hydroxide, stirring to dissolve the arginine, and heating to hydrolyze so as to completely transform the arginine into ornithine; adding aspartate, uniformly stirring, adding a precipitator, filtering to remove barium ion precipitate, and regulating the pH value of the solution to neutrality; adding an inert organic solvent for crystallization, filtering and pumping, adding water for injection to dissolve the crystals, adding active carbon for needle for decoloration and depyrogenation, coarsely filtering to remove carbon, and filtering to make the solution sterile and clarified by using a 0.22 mu m millipore filter; and adding ethanol for crystallization, obtaining ornithine aspartate sterile powder, packaging the powder into a sterilized vial, capping, and rolling an aluminum cover to obtain the ornithine aspartate sterile powder injection for injection. The method has the advantages of increasing the yield, preparing the ornithine aspartate by the one-pot method, along with easy operation, simple and convenient operation, low cost, short production period, and suitability for mass production.

Description

technical field [0001] The invention relates to the technical field of medicine, and more specifically relates to a method for preparing ornithine-aspartate powder for injection by solvent crystallization. This product treats hyperammonemia caused by acute and chronic liver diseases such as liver cirrhosis, fatty liver and hepatitis, and is especially suitable for the relief of central nervous system symptoms and rescue of hepatic coma caused by liver diseases. Background technique [0002] Ornithine Aspartate (Ornithine Aspartate) is a salt formed by the chemical reaction of L-Ornithine and L-Aspartic acid. The chemical name is (S)-2,5-diaminopentanoic acid-(S) )-2-aminosuccinate. its chemistry [0003] The structural formula is as follows (National Drug Administration Standard WS-745 (X-592-2001)): [0004] [0005] Ornithine aspartate can provide a substrate for the synthesis of urea and glutamine. And glutamine is the detoxification product of ammonia, and it is a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/205C07C229/26C07C229/24C07C227/18A61P1/16A61P3/00A61P25/28
Inventor 刘万忠刘伟华
Owner HUBEI HOPE PHARMA
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