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Method for preparing compound amino acid injection liquid (20AA)

A compound amino acid, injection technology, applied in pharmaceutical formulations, metabolic diseases, peptide/protein components, etc., can solve problems such as affecting product quality and amino acid instability

Inactive Publication Date: 2013-03-13
湖北一半天制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a preparation method for compound amino acid injection (20AA), to solve the problem of affecting product quality due to amino acid instability in the preparation process of amino acid solution

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Prepare compound amino acid injection according to the following steps:

[0059] A. Weigh the following components according to the formula amount per 1000ml of compound amino acid injection:

[0060] L-Isoleucine 8.80

[0061] L-leucine 13.60

[0062] L-Lysine acetate 10.60

[0063] L-methionine 1.20

[0064] L-phenylalanine 1.60

[0065] L-threonine 4.60

[0066] L-Tryptophan 1.50

[0067] L-valine 10.60

[0068] L-Arginine 8.80

[0069] L-histidine 4.70

[0070] Glycine 6.30

[0071] L-alanine 8.30

[0072] L-proline 7.10

[0073] L-Aspartic Acid 2.50

[0074] L-Asparagine 0.55

[0075] L-glutamic acid 5.70

[0076] L-ornithine hydrochloride 1.66

[0077] L-serine 3.70

[0078] N-acetyl-L-tyrosine 0.86

[0079] N-acetyl-L-cysteine ​​0.80

[0080] B. Fill the production process with nitrogen to ensure that the residual oxygen rate of the solution is below 4%;

[0081] C. Add 90% of the total amount of water for injection into the preparation contain...

Embodiment 2

[0089] Prepare compound amino acid injection according to the following steps:

[0090] A. Weigh the following components according to the formula amount per 1000ml of compound amino acid injection:

[0091] L-Isoleucine 8.80

[0092] L-leucine 13.60

[0093] L-Lysine acetate 10.60

[0094] L-methionine 1.20

[0095] L-phenylalanine 1.60

[0096] L-Threonine 4.60

[0097] L-Tryptophan 1.50

[0098] L-valine 10.60

[0099] L-Arginine 8.80

[0100] L-histidine 4.70

[0101] Glycine 6.30

[0102] L-alanine 8.30

[0103] L-proline 7.10

[0104] L-Aspartic Acid 2.50

[0105] L-Asparagine 0.55

[0106] L-glutamic acid 5.70

[0107] L-ornithine hydrochloride 1.66

[0108] L-serine 3.70

[0109] N-acetyl-L-tyrosine 0.86

[0110] N-acetyl-L-cysteine ​​0.80

[0111] B. Fill the production process with nitrogen to ensure that the residual oxygen rate of the solution is below 4%;

[0112] C. Add 90% of the total amount of water for injection into the preparation contain...

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PUM

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Abstract

The invention mainly relates to a method for preparing compound amino acid injection liquid (20AA), and belongs to the technical field of medicines. The problems that the amino acid is oxidized and degraded and solution color is deepened because the solution is in contact with oxygen for a long time during preparation and filling are solved by vacuumizing and filling nitrogen during preparation of the injection liquid. In the method, the injection liquid is dissolved in batch or in several times according to the dissolution difficulty of amino acid, so that the problem that the indissolvable amino acid crystal separates out during preparation is solved, and the stability and the quality of the amino acid injection liquid are guaranteed to the maximum limit. The method has the advantages of simple operation, scientific and reasonable process, low cost and low requirement on production equipment.

Description

technical field [0001] Compound amino acid injection (20AA) is a high-concentration compound branched-chain amino acid injection prepared from 20 kinds of amino acids and a stabilizer. The invention relates to a preparation method of the drug. Background technique [0002] Compound Amino Acid Injection (20AA) belongs to the fourth-generation highly branched-chain amino acid injection. Based on the balanced formula of the third-generation amino acid injection, it increases the proportion of branched-chain amino acids to 33%. Branched-chain amino acids function as energy substrates, gluconeogenesis substrates, and muscle protein regulators. It can be oxidized in the periphery as an energy source, which can increase energy intake without increasing the burden on the liver, and can be used as a substrate for gluconeogenesis. There is a cyclic metabolic mechanism between oxidation and alanine synthesis in the body , generating more heat. Each gram of leucine, isoleucine, and v...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K31/405A61K31/401A61K31/198A61K31/195A61K9/08A61P3/02
Inventor 易镇海李方芝
Owner 湖北一半天制药有限公司
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