L-ornithine L-aspartate salt injection solution and preparation method thereof

A technology of ornithine aspartate and injection, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and medical preparations without active ingredients, etc., can solve the problem of no ornithine aspartate injection. Difficult to guarantee bacterial properties, unknown impurity form and dissolution amount, hidden dangers of drug safety, etc., to achieve excellent drug stability, improve drug safety, and simplify the production process.

Active Publication Date: 2019-10-11
SHANGHAI MAIUS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since activated carbon itself contains a variety of impurities, there is a risk of leaching impurities into the injection during the adsorption process, and the form and amount of these impurities are unknown, resulting in potential drug safety hazards
However, if activated carbon is not used to adsorb the pyrogens present in the aspartic acid ornithine injection, the sterility of the aspartic acid ornithine injection is difficult to guarantee, which in turn creates a safety hazard

Method used

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  • L-ornithine L-aspartate salt injection solution and preparation method thereof
  • L-ornithine L-aspartate salt injection solution and preparation method thereof
  • L-ornithine L-aspartate salt injection solution and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1-7

[0034] Example 1-7 Preparation of Ornithine Aspartate Injection

[0035] The formula of ornithine aspartate injection is shown in Table 1.

[0036] Table 1 Ornithine Aspartate Injection Formulation

[0037]

[0038] Specific preparation method

[0039] Prepare Ornithine Aspartate Injection according to the injection formula of Table 1, and the concrete steps are as follows:

[0040] 1) Weigh the mannitol and sodium metabisulfite of the formula amount, dissolve them in 50%~70% of the water for injection of the prepared volume, stir and mix evenly, then add the ornithine aspartate of the formula amount, wait for the ornithine aspartate After all the amino acids are dissolved, adjust the pH with a pH adjuster, control the pH value of the ornithine aspartate injection to be 6.2-7.0, and then add water for injection to make up the total volume.

[0041] 2) The ornithine aspartate injection prepared in step 1) is subjected to sterilization filtration, filling with nitrogen, me...

Embodiment 8

[0046] Embodiment 8, sample stability detection

[0047] In order to investigate the stability of the Ornithine Aspartate Injection of the present invention, the newly prepared Ornithine Aspartate Injection (0 days) and the stability after storage were respectively tested in Examples 1-7.

[0048]Since the conventional storage time is usually 18 months or longer, the present invention stores the Asparagus of the present invention under more severe conditions than the conventional storage conditions (for example: light (4500lx±5001x), high temperature (60°C) conditions) Ornithine amino acid injection, and test the stability of the injection after storage. The details are as follows:

[0049] (1), detect the character, pH value, related substance mass content, ornithine aspartate mass content and bacterial endotoxin of the aspartate ornithine aspartate injection prepared by embodiment 1-7 respectively, test result As shown in table 2.

[0050] Table 2. Test results of ornithi...

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Abstract

The invention provides a L-ornithine L-aspartate salt injection solution. The injection solution comprises L-ornithine L-aspartate salt, mannitol, sodium pyrosulfite, a pH adjuster and water for injection. The concentration range of the mannitol is 25-150 mg/ml; the concentration range of the sodium pyrosulfite is 0.05-3 mg/ml; the pH value of the L-ornithine L-aspartate salt injection solution is6.2-7.0. The invention further provides application and a preparation method of the injection solution. The L-ornithine L-aspartate salt injection solution has excellent stability, the medicine application safety of the L-ornithine L-aspartate salt injection solution is obviously improved, the production technology is simplified, large-scale industrial production is conveniently conducted, and the L-ornithine L-aspartate salt injection solution has important significance of medical science.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to an injection of ornithine aspartate and a preparation method thereof. Background technique [0002] Ornithine aspartate is a dipeptide compound prepared from L-ornithine and L-aspartic acid by chemical synthesis. It is usually prepared as ornithine aspartate injection for clinical application. Ornithine Aspartate Injection enters the human body, and Ornithine Aspartate is decomposed into aspartic acid and ornithine, which can directly participate in the metabolism of liver cells and activate two keys in the detoxification function of the liver. Enzymes can help remove free radicals harmful to the human body, enhance the detoxification function of the liver, rapidly reduce excessive blood ammonia, and promote the repair and regeneration of liver cells themselves, thereby effectively improving liver function and restoring the body's energy balance. [0003] O...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/205A61P1/16A61P25/00
CPCA61K9/08A61K9/0019A61K31/205A61K47/26
Inventor 黄杜坚史命锋薛兴伟
Owner SHANGHAI MAIUS PHARM CO LTD
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