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A kind of aspartic acid ornithine injection and preparation method thereof

A technology of ornithine aspartate and injection, which is applied in the field of medicine, can solve the problems of increased ornithine content, unstable solution quality, complicated preparation process, etc., and achieves reduction of hydrolysis and poor physical and chemical stability. , the effect of high drug safety

Active Publication Date: 2021-02-02
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] CN101961315A discloses the method of using liposomes to encapsulate active ingredients. Although this method can play a role in stability, it has the disadvantages of large amount of auxiliary materials, complicated preparation process, and high cost.
[0007] CN104173280A discloses a composition comprising ornithine aspartate, poloxamer, ursodeoxycholic acid, and water for injection. In this patent, high-temperature sterilization is used, which may easily cause the increase of ornithine content
[0008] CN103655533A discloses a lyophilized powder comprising ornithine aspartate, mannitol, anhydrous sodium carbonate and water for injection for an injection-used ornithine-aspartate pharmaceutical composition, which also causes The problem of high impurity content
The phenomenon of unstable solution quality

Method used

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  • A kind of aspartic acid ornithine injection and preparation method thereof
  • A kind of aspartic acid ornithine injection and preparation method thereof
  • A kind of aspartic acid ornithine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Ornithine Aspartate Injection is prescribed as:

[0039] Include the following weight components in the described injection of every 1000ml:

[0040]

[0041] The preparation process of ornithine aspartic acid injection is as follows:

[0042](1) Pre-purification of ornithine aspartate: Dissolve the raw material of ornithine aspartate in purified water, stir to dissolve and add activated carbon for decolorization. After filtration, the filtrate is heated to 45°C, slowly added methanol dropwise, and then cooled Crystallize at room temperature, filter, wash the filter cake with methanol, and dry under vacuum at 45°C to obtain pre-purified ornithine aspartate;

[0043] (2) In a 2L configuration container, add 50% of the prescribed amount of water for injection, pass nitrogen to saturation, slowly add the prescribed amount of metal ion complexing agent disodium edetate, stir and dissolve;

[0044] (3) use citric acid-sodium citrate buffer to adjust the pH 4.5 of step (...

Embodiment 2

[0048] Ornithine Aspartate Injection is prescribed as:

[0049] Include the following weight components in the described injection of every 1000ml:

[0050]

[0051] The preparation process of ornithine aspartic acid injection is as follows:

[0052] (1) Pre-purification of ornithine aspartate: Dissolve the raw material of ornithine aspartate in purified water, stir to dissolve and add activated carbon for decolorization. Crystallize at room temperature, filter, wash the filter cake with ethanol, and dry under vacuum at 65°C to obtain pre-purified ornithine aspartate;

[0053] (2) In a 2L configuration container, add 50% of the prescribed amount of water for injection, pass nitrogen to saturation, slowly add the prescribed amount of metal ion complexing agent calcium sodium edetate, stir and dissolve;

[0054] (3) Use potassium hydrogen phthalate-sodium hydroxide buffer to adjust the pH 6.0 of step (2) Chinese medicinal liquid;

[0055] (4) After the medicinal solution i...

Embodiment 3

[0058] Ornithine Aspartate Injection is prescribed as:

[0059] Include the following weight components in the described injection of every 1000ml:

[0060]

[0061] The preparation process of ornithine aspartic acid injection is as follows:

[0062] (1) Pre-purification of ornithine aspartate: Dissolve the raw material of ornithine aspartate in purified water, stir to dissolve and add activated carbon for decolorization. After filtration, the filtrate is heated to 50°C, and polyethylene glycol is slowly added dropwise. Then cool to room temperature for crystallization, filter, wash the filter cake with polyethylene glycol, and vacuum-dry at 50°C to obtain pre-purified ornithine aspartate;

[0063] (2) In a 2L configuration container, add 50% of the prescribed amount of water for injection, pass nitrogen to saturation, slowly add the prescribed amount of metal ion complexing agent disodium edetate, stir and dissolve;

[0064] (3) Use acetic acid-sodium acetate buffer to a...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to an ornithine-aspartate injection and a preparation method thereof. If impurities such as amide, arginine, and dimeric ornithine exceed the standard, the following prescription is adopted: including pre-purified aspartic acid ornithine, metal ion complexing agent, pH buffer pair and water for injection, in which the pH buffer pair In order to maintain the stable pH of the injection, the metal ion complexing agent avoids the decomposition and catalysis of the main drug by the metal ion; the preparation process of the present invention includes: two parts: pre-purification of aspartic acid ornithine and preparation of the medicinal solution, wherein Pre-purification adopts the method of recrystallization. During the preparation of the medicinal solution, two sterilization methods are adopted: 121°C high-pressure steam sterilization for 15 minutes and 0.22 μm microporous membrane. The injection of the present invention has stable physical and chemical properties and low impurity content , can be stored for a long time.

Description

technical field [0001] The invention belongs to the technical field of medicine, relates to a pharmaceutical preparation and a preparation method thereof, in particular to an ornithine-aspartate injection and a preparation method thereof. Background technique [0002] Aspartic acid ornithine (chemical name is (S)-2,5-diaminovaleric acid (s)-2-aminosuccinate), clinically used in Germany in the 1970s, recorded in 1991 German Pharmacopoeia, imported and listed in China in 2000, and produced by domestic manufacturers in 2006. It is used to treat hyperammonemia caused by liver lesions. Ornithine aspartate can provide a substrate for the synthesis of urea and glutamine in the body. Under physiological and pathological conditions, the synthesis of urea and the synthesis of glutamine will be affected by ornithine, aspartic acid and other dicarboxylic compounds; ornithine is almost involved in the activation of urea cycle and the whole process of detoxification of ammonia ; In this ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/205A61K47/12A61K47/18A61P1/16A61P25/00
CPCA61K9/0019A61K9/08A61K31/205A61K47/12A61K47/183
Inventor 张冬梅张颖刘奎伟王彩霞张旭车文文吕密慧
Owner JINAN KANGHE MEDICAL TECH
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