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Pharmaceutical composition containing 18 amino acids

A technology of amino acid and composition, which is applied in the field of medicine and can solve problems such as huge investment

Inactive Publication Date: 2012-08-08
郑飞雄
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] It is worth pointing out that the vast majority of compound amino acid injection manufacturers in my country do not yet have the process conditions and equipment for the whole production process of nitrogen protection. There are still uncertainties about whether the goal will be achieved

Method used

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  • Pharmaceutical composition containing 18 amino acids
  • Pharmaceutical composition containing 18 amino acids
  • Pharmaceutical composition containing 18 amino acids

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] 1. Prescription:

[0135]

[0136] The total amount of mixed injection is 100000ml;

[0137] 2. Preparation process

[0138] (1) Weigh the ingredients and excipients according to the prescription;

[0139] (2) Add water for injection into the dispensing tank, heat and boil, repeatedly use vacuuming and nitrogen filling to reduce the oxygen content in the dispensing tank, and then fill the tank with nitrogen at a water temperature of 100℃-50℃. Input raw materials: citric acid, tyrosine, leucine, isoleucine, valine, methionine, medicinal activated carbon, phenylalanine, glutamic acid, aspartic acid, lysine acetate Acid, threonine, glycine, glucose, arginine, alanine, proline, serine, cysteine ​​hydrochloride, histidine and N-acetyl-L-tryptophan, stir until completely dissolved, use Adjust the pH to 3.8 with acetic acid or NaOH solution, add water for injection to the specified volume, stir evenly, and then continuously filter the crude filtrate through 0.45μm, 0.22μm microporou...

Embodiment 2

[0142] 1. Prescription:

[0143]

[0144] The total amount of prepared injection is 10000ml;

[0145] 2. The preparation process The preparation process is the same as in Example 1, but the pH of the preparation is 4.2.

Embodiment 3

[0147] 1. Prescription:

[0148]

[0149]

[0150] The total amount of mixed injection is 100000ml;

[0151] 2. Preparation process

[0152] (1) Weigh the ingredients and excipients according to the prescription;

[0153] (2) Add water for injection into the dispensing tank, heat and boil, repeatedly use vacuum and nitrogen replacement treatments to reduce the oxygen content in the dispensing tank, and then fill with nitrogen throughout the entire process at a water temperature of 100℃-50℃. Input raw materials: tartaric acid, tyrosine, leucine, isoleucine, valine, methionine, medicinal activated carbon, phenylalanine, glutamic acid, aspartic acid, lysine acetate , Threonine, glycine, glucose, arginine, alanine, proline, serine, cysteine ​​hydrochloride, histidine and N-acetyl-L-tryptophan, stir until completely dissolved, use acetic acid Or adjust the pH to 4.0 with NaOH solution, add water for injection to the specified volume, stir evenly, and then filter the crude filtrate throug...

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PUM

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Abstract

The invention discloses a pharmaceutical composition containing 18 amino acids. The pharmaceutical composition containing 18 amino acids is characterized in that raw materials of 18 amino acids and auxiliary materials of an antioxidant and a pH conditioning agent are prepared into compound amino acid injections (18AA-IV) having different concentrations, wherein the compound amino acid injection is the pharmaceutical composition containing 18 amino acids and has a pH value of 3.5 to 5.5. The pharmaceutical composition containing 18 amino acids does not contain a sulfite antioxidant and thoroughly prevents the damage of sulfites on the human body. Products of the pharmaceutical composition containing 18 amino acids are safer in clinical use. An accelerated stability test proves that the pharmaceutical composition (18AA-IV) containing 18 amino acids has the stability the same as or superior to the stability of commercial sulfite-containing like products.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and more specifically relates to a pharmaceutical composition containing 18 amino acids. Background technique [0002] The pharmaceutical composition containing 18 kinds of amino acids is a sterile aqueous solution prepared by adding 18 kinds of amino acids and auxiliary materials, and is clinically used as a parenteral nutrition. [0003] Since amino acids are very unstable in solution, they are easily oxidized to produce a series of complex substances harmful to the human body. Since the compound amino acid injection was put into production in the 1960s, in order to ensure the stability of the product, sulfites with unique antioxidant capacity must be added, such as sodium bisulfite and sodium metabisulfite. Since people did not understand the harm of such substances to the human body at the time, manufacturers usually added in large quantities without restriction to ensure the stability of their pr...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K31/405A61K31/401A61K31/198A61K31/195A61P3/02
Inventor 郑飞雄
Owner 郑飞雄