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Compound amino acid injection and preparation method thereof

A compound amino acid and injection technology, applied in the field of medicine, can solve problems such as affecting calcium ion levels and inappropriateness, and achieve the effects of eliminating toxic and side effects, appropriate nitrogen filling level, and reasonable production equipment requirements

Inactive Publication Date: 2013-02-27
湖北长联杜勒制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But we should see that the national standard formula of Compound Amino Acid Injection 18AA-Ⅶ does not contain chloride ions, so it is inappropriate to choose cysteine ​​hydrochloride
In addition, citric acid, as an uncommon metal chelator, will affect the level of calcium ions in the blood during use, and there is a certain risk

Method used

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  • Compound amino acid injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription: Leucine 12.9kg, Threonine 7.5kg, Isoleucine 9.1kg, Glycine 7.0kg, Valine 14.0kg, Phenylalanine 7.0kg, Tryptophan 1.3kg, Methionine 4.4kg , glutamic acid 0.5kg, alanine 7.1kg, serine 1.7kg, proline 5.0kg, tyrosine 0.4kg, lysine acetate 10.0kg, arginine 9.0kg, histidine 5.0kg, door Aspartic acid 1.0kg, cysteine ​​0.35kg, edetate calcium sodium 0.05kg, glacial acetic acid amount, add water to 1000000mL.

[0035] The preparation method of this compound amino acid injection comprises the following steps:

[0036] 1) Add 600,000 mL of water for injection into the concentrated tank, fill it with nitrogen for 15 minutes while heating, add calcium and sodium edetate at 100°C to dissolve, then add tyrosine, leucine, isoleucine, valine Acid and methionine were stirred and dissolved, and the heating was stopped;

[0037] 2) Under the condition of nitrogen protection, cool down the solution obtained in step 1) to 65-75°C, add phenylalanine, glutamic acid, aspartic ac...

Embodiment 2

[0042] Prescription: Leucine 11.6kg, Threonine 6.8kg, Isoleucine 8.2kg, Glycine 6.3kg, Valine 12.6kg, Phenylalanine 6.3kg, Tryptophan 1.2kg, Methionine 4.0kg , glutamic acid 0.4kg, alanine 6.4kg, serine 1.5kg, proline 4.5kg, tyrosine 0.35kg, lysine acetate 9.0kg, arginine 8.1kg, histidine 4.5kg, aspart Amino acid 0.9kg, cysteine ​​0.3kg, edetate calcium sodium 0.04kg, glacial acetic acid amount, add water amount to 1000000ml.

[0043] The preparation method of this compound amino acid injection comprises the following steps:

[0044] 1) Add 600,000 mL of water for injection into the concentrated tank, fill it with nitrogen for 15 minutes while heating, add calcium and sodium edetate at 100°C to dissolve, then add tyrosine, leucine, isoleucine, valine Acid and methionine were stirred and dissolved, and the heating was stopped;

[0045] 2) Under the condition of nitrogen protection, cool down the solution obtained in step 1) to 65-75°C, add phenylalanine, glutamic acid, aspart...

Embodiment 3

[0050] Prescription: Leucine 14.2kg, Threonine 8.3kg, Isoleucine 10.0kg, Glycine 7.7kg, Valine 15.4kg, Phenylalanine 7.7kg, Tryptophan 1.4kg, Methionine 4.8kg , glutamic acid 0.6kg, alanine 7.8kg, serine 1.9kg, proline 5.5kg, tyrosine 0.45kg, lysine acetate 11.0kg, arginine 9.9kg, histidine 5.5kg, asparagine Amino acid 1.1kg, cysteine ​​0.4kg, edetate calcium sodium 0.06kg, glacial acetic acid amount, add water amount to 1000000ml.

[0051] The preparation method of this compound amino acid injection comprises the following steps:

[0052] 1) Add 600,000 mL of water for injection into the concentrated preparation tank, fill with nitrogen for 15 minutes while heating, add calcium and sodium edetate at 100°C to dissolve, then add tyrosine, leucine, isoleucine, valine Acid and methionine were stirred and dissolved, and the heating was stopped;

[0053] 2) Under the condition of nitrogen protection, cool down the solution obtained in step 1) to 65-75°C, add phenylalanine, glutam...

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Abstract

A compound amino acid injection provided by the invention comprises the following solvents in every 1000 mL: 11.6-14.2g of leucine, 6.8-8.3g of threonine, 8.2-10.0g of isoleucine, 6.3-7.7g of glycine, 12.6-15.4g of valine, 6.3-7.7g of phenylalanine, 1.2-1.4g of tryptophan, 4.0-4.8g of methionine, 0.4-0.6g of glutamic acid, 6.4-7.8g of alanine, 1.5-1.9g of serine, 4.5-5.5g of proline, 0.35-0.45g of tyrosine, 9.0-11.0g of lysine acetate, 8.1-9.9g of arginine, 4.5-5.5g of histidine, 0.9-1.1g of aspartate, 0.3-0.4g of cysteine, and 0.04-0.06g of calcium disodium edetate. The injection does not contain sulfite antioxidant, and employs cysteine and sodium calcium edetate as antioxidants and metal chelators; and nitrogen is used for protection in a production process, so as to reduce oxygen content in solution as much as possible and produce safer product for clinical usage.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a composition containing 18 kinds of amino acids and a preparation method thereof. Background technique [0002] Compound Amino Acid Injection (18AA-Ⅶ) is a sterilized aqueous solution prepared from 18 kinds of amino acids and auxiliary materials. It is clinically used as an amino acid supplement. For patients who cannot take oral or enteral nutritional supplements, or whose nutrition cannot meet their needs, it can be administered intravenously. Infusion of this product to meet the needs of the body to synthesize protein. [0003] Since amino acids are unstable in aqueous solution, they are easily oxidized to produce a series of complex substances harmful to human body. The production of compound amino acid injection at home and abroad is mainly to add sulfite (sodium bisulfite or sodium pyrosulfite, etc.) antioxidants, and carry out nitrogen flushing protection in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K9/08A61K47/20A61K47/18A61P3/02
Inventor 刘义阙宗彬刘先言梁万金鄢荣榜
Owner 湖北长联杜勒制药有限公司
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