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Preparation method of compound amino acid injection containing peptides

A compound amino acid and injection technology, which is applied in the field of amino acid composition preparation, can solve the problems of poor water solubility and poor stability of amino acids, and achieve the effect of increasing solubility and improving stability

Inactive Publication Date: 2016-07-20
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The purpose of the present invention is to provide a method for preparing peptide-containing compound amino acid injection, which can improve the problems of poor water solubility and poor stability of some amino acids in the existing preparation process, making it safer and more effective for clinical use

Method used

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  • Preparation method of compound amino acid injection containing peptides
  • Preparation method of compound amino acid injection containing peptides
  • Preparation method of compound amino acid injection containing peptides

Examples

Experimental program
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Effect test

Embodiment 1

[0031] Under full nitrogen protection, take 60% of the total volume of water for injection, boil for 30 minutes, cool down to 80-100°C, add the prescribed amount of leucine, isoleucine, valine, and methionine in sequence, and stir Dissolve and clear; cool down to 65-85°C, add the prescribed amount of phenylalanine, glutamic acid, aspartic acid, lysine acetate, threonine in turn, stir to dissolve clear; cool down to 55-75°C , add the prescription amount of glycyl-L-glutamine, glycyl-L-tyrosine and arginine in turn, add the prescription amount of alanine, histidine, proline, Serine: cool down to 40-55°C, add the prescribed amount of tryptophan, stir well to obtain a compound amino acid aqueous solution, adjust the pH to 5.8 with malic acid, add 0.01% (w / v) medicinal activated carbon at 45-55°C After decolorization and endotoxin removal, use the infusion pump to circulate sequentially through a 5μm titanium rod filter, 0.45μm and 0.22μm cartridge filter, and then transport it to ...

Embodiment 2

[0034] Under full nitrogen protection, take 70% of the total volume of water for injection, boil for 45 minutes, cool down to 80-100°C, add the prescribed amount of leucine, isoleucine, valine, and methionine in sequence, and stir Dissolve and clear; cool down to 65-85°C, add the prescribed amount of phenylalanine, glutamic acid, aspartic acid, lysine acetate, threonine in turn, stir to dissolve clear; cool down to 55-75°C , add the prescription amount of glycyl-L-glutamine, glycyl-L-tyrosine and arginine in turn, add the prescription amount of alanine, histidine, proline, Serine: cool down to 40-55°C, add tryptophan in the prescribed amount, stir well to obtain a compound amino acid aqueous solution, adjust the pH to 6.0 with rosmarinic acid, add 0.02% (w / v) of the drug at 45-55°C After using activated carbon to decolorize and remove endotoxin, use an infusion pump to circulate through a 5μm titanium rod filter, 0.45μm and 0.22μm cartridge filter in sequence, and then transpo...

Embodiment 3

[0037] Under full nitrogen protection, take 80% of the total volume of water for injection, boil for 60 minutes, cool down to 80-100°C, add the prescribed amount of leucine, isoleucine, valine, and methionine in sequence, and stir Dissolve and clear; cool down to 65-85°C, add the prescribed amount of phenylalanine, glutamic acid, aspartic acid, lysine acetate, threonine in turn, stir to dissolve clear; cool down to 55-75°C , add the prescription amount of glycyl-L-glutamine, glycyl-L-tyrosine and arginine in turn, add the prescription amount of alanine, histidine, proline, Serine: cool down to 40-55°C, add the prescribed amount of tryptophan, stir evenly to obtain a compound amino acid aqueous solution, adjust the pH to 6.0 with malic acid and rosmarinic acid, add 0.05% (w / v ) of medicinal activated carbon for decolorization and endotoxin removal, and then use an infusion pump to circulate through a 5μm titanium rod filter, 0.45μm and 0.22μm cartridge filter, and then transpor...

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Abstract

The invention discloses a preparation method of a compound amino acid injection containing peptides. The preparation method comprises following steps: under nitrogen protection, injection water with a total volume dose less than 90% is boiled; the boiled injection water is cooled to 80 to 100 DEG C, amino acids are added at formula dosages, and then the boiled injection water is cooled to 65 to 85 DEG C, and amino acids are added at formula dosages, wherein the amino acids added in the step are different amino acids; the boiled injection water is cooled to 55 to 75 DEG C, and glycyl-L-glutamine, glycyl-L-tyrosine, and arginine are added at formula dosages, an obtained mixture is stirred and clarified, and alanine, histidine, proline, and serine are added at formula dosages; an obtained mixed material is cooled to 40 to 55 DEG C, tryptophan is added at a formula dosage, a compound amino acid aqueous solution is obtained via uniform stirring, and pH value is adjusted to 5.0 to 6.5 with a pH conditioning agent. According to the preparation method, dissolving of different amino acids is realized gradually in different temperature ranges, so that amino acid solubility is increased, and stability is not destroyed.

Description

technical field [0001] The invention relates to a preparation method of an amino acid composition, in particular to a preparation method of a peptide-containing compound amino acid injection. Background technique [0002] Peptide-containing compound amino acid injection was first produced by FreseniusKabi Company in Germany, and its trade name was Glamin. It was registered and listed in Germany, Switzerland, Sweden, Finland, Denmark and the United Kingdom in May 1995. This product is a compound balanced amino acid injection containing glycyl-glutamine, glycyl-tyrosine and 15 kinds of amino acids. Each liter contains 20g of glutamine in the form of glycyl-glutamine , tyrosine 2.28g, nitrogen concentration 2.24g / 100ml. Since no free glycine is added, no amino acid imbalance occurs at the amino terminus of the dipeptide structure. Therefore, this product is more perfect than ordinary compound amino acid injection, especially for critically ill patients with trauma, sepsis and...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K9/08A61P3/02A61K31/4172A61K31/401A61K31/405
Inventor 郑璐吕泉福张益波吴斌姚书扬高苇徐海龙周艳红
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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