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L-onithine and L-aspartic acid composition

A technology of aspartic acid and ornithine, which is applied in the field of freeze-dried products for injection or sterile subpackaged products for injection, and sterile powder composition for injection, can solve the adverse reactions of human body, easy-visible light decomposition, drug irritation and other problems, to achieve the effect of being conducive to long-term storage, simple production process, and no environmental pollution

Inactive Publication Date: 2005-02-23
WUHAN QR SCI & TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Although L-ornithine-L-aspartic acid injection has a good therapeutic effect on hepatitis and hepatic coma, due to the structure of L-ornithine in the composition, the free L-ornithine solid is in the It is relatively unstable at room temperature, and it is easier to be oxidized than the salt-forming L-ornithine in aqueous solution; L-ornithine-L-aspartic acid injection is easy to decompose when exposed to light, producing impurities without therapeutic effect, which may cause Human adverse reactions and drug irritation affect the quality of this product and shorten the validity period of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Embodiment 1: Preparation method 1 of freeze-dried product for injection

[0013] Take 200g of L-ornithine L-aspartic acid and add 500ml of water for injection to dissolve, add 1g of activated carbon, stir for 30min to decolorize, filter, add water for injection to 1000ml, and pack in sterilized penicillin by 12.5ml per bottle bottle, freeze-dried at low temperature, and then aseptically packaged to make a freeze-dried product.

Embodiment 2

[0014] Embodiment 2: Preparation method 2 of freeze-dried product for injection

[0015] Take 100g of L-ornithine and 100g of L-aspartic acid and add 500ml of water for injection to dissolve, add 1g of activated carbon, stir for 30min to decolorize, filter, add water for injection to 1000ml, and pack in 2.5ml per bottle. After being freeze-dried at a low temperature and then aseptically packaged, it is made into a freeze-dried product.

Embodiment 3

[0016] Example 3: Preparation Method 1 of Sterile Drug Powder or Sterile Subpackaged Product for Injection Purified by Sterilization or Sterile Solution Crystallization

[0017] Take 100g of L-ornithine and 100g of L-aspartic acid respectively, add 500ml of water for injection to dissolve, add 1g of activated carbon, stir and decolorize for 30min, filter, concentrate by reducing pressure, and crystallize to obtain the required drug solid, and the obtained The solids were crushed under aseptic conditions and sieved to obtain sterile raw materials. Then, the prepared powder is divided into sterile containers under aseptic conditions, and aseptically packaged to obtain the product.

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PUM

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Abstract

A powder injection for preventing and treating hepatitis, the hyperammonemia caused by hepatitis, the disease in central nerve system caused by hepatism and the diseases caused by deficiency of L-ornithin or L-aminosuccinic acid is prepared from L-ornithin and L-aminosuccinic acid or the L-ornithin-L-aminosuccinic acid salt through dissolving in water, filtering and freeze drying.

Description

technical field [0001] The present invention relates to a composition containing L-ornithine and L-aspartic acid or containing L-ornithine-L-aspartic acid, in particular to a sterile powder composition for injection, i.e. frozen Dry products or sterile subpackaged products for injection. Background technique [0002] Although L-ornithine-L-aspartic acid injection has a good therapeutic effect on hepatitis and hepatic coma, due to the structure of L-ornithine in the composition, the free L-ornithine solid is in the It is relatively unstable at room temperature, and it is easier to be oxidized than the salt-forming L-ornithine in aqueous solution; L-ornithine-L-aspartic acid injection is easy to decompose when exposed to light, producing impurities without therapeutic effect, which may cause Human adverse reactions and drug irritation affect the quality of this product and shorten the validity period of the drug. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/198A61P1/16A61P31/12
Inventor 王朝东
Owner WUHAN QR SCI & TECH DEV
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