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Compound amino acid injection and preparation method thereof

A compound amino acid and injection technology, which is applied in the direction of medical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the safety hazards of compound amino acid injections and reduce the degradation of tryptophan, etc. Achieve stable properties, reduce degradation, and simplify the prescription process

Inactive Publication Date: 2019-11-29
武汉久安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Based on the physical and chemical properties of the above compound amino acid injection, most manufacturers often take two measures to control product quality: 1. Add sulfite antioxidants or metal ion chelating agents to reduce tryptophan degradation; 2. Add appropriate amount of activated carbon Carry out decolorization, to meet the character requirement of injection, these two kinds of methods have all brought certain potential safety hazard for compound amino acid injection

Method used

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  • Compound amino acid injection and preparation method thereof
  • Compound amino acid injection and preparation method thereof

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preparation example Construction

[0017] Please refer to figure 1 , the embodiment of the present invention provides a kind of preparation method of compound amino acid injection, comprises the following steps:

[0018] Step S1, pre-production treatment: wash the preparation container and pipeline with alkaline water, metal ion chelating agent solution and water for injection respectively;

[0019] Step S2, take 40% of the water for injection and put it in the liquid mixing tank, put in the prescribed amount of sodium hydroxide, stir while adding, and stir until dissolved;

[0020] Step S3, filling the liquid distribution tank with N 2 , keep warm at 50-75°C, and then put in the prescribed amount of tyrosine, isoleucine, leucine, lysine hydrochloride, methionine, threonine, valine, alanine, Arginine hydrochloride, aspartic acid, glutamic acid, proline, serine, glycine, phenylalanine, histidine hydrochloride, xylitol, cysteine ​​hydrochloride, and stir to dissolve one by one;

[0021] Step S4, continue to fe...

Embodiment 1

[0026] Rinse the preparation container and pipeline with alkaline water, metal ion chelating agent solution and water for injection respectively; take 350ml of water for injection and place it in the liquid mixing tank, put in 1.1g of sodium hydroxide, and stir until dissolved while adding; Fill the liquid tank with N 2 , keep warm at 65°C, then add 1.03g tyrosine, 1.74g isoleucine, 3.75g leucine, 3.33g lysine hydrochloride, 1.06g methionine, 1.95g threonine, 1.35g g valine, 1.82g alanine, 2.76g arginine hydrochloride, 1.26g aspartic acid, 1.87g glutamic acid, 0.98g proline, 0.75g serine, 3.22g glycine, 2.76g phenylalanine acid, 2.43g histidine hydrochloride, 52g xylitol, 0.46g cysteine ​​hydrochloride, and stir and dissolve one by one; 2 , ensure that the oxygen content in the liquid mixing tank is within 3%, cool down to 45°C, add 420ml of water for injection, and then add 0.41g of tryptophan, stir and dissolve, replenish water to 1000ml, and obtain a mixed solution; use 0....

Embodiment 2

[0038] Rinse the preparation container and pipeline with alkaline water, metal ion chelating agent solution and water for injection respectively; take 400ml water for injection and place it in the liquid mixing tank, drop in 1.3g sodium hydroxide, and stir until dissolved while adding; Fill the liquid tank with N 2 , kept at 70°C, and then put in 1.13g tyrosine, 1.64g isoleucine, 3.68g leucine, 3.27g lysine hydrochloride, 1.03g methionine, 1.90g threonine, 1.25g g valine, 1.85g alanine, 2.72g arginine hydrochloride, 1.12g aspartic acid, 1.81g glutamic acid, 0.87g proline, 0.67g serine, 3.18g glycine, 2.83g phenylalanine acid, 2.41g histidine hydrochloride, 48g xylitol, 0.41g cysteine ​​hydrochloride, and stir and dissolve one by one;2 , ensure that the oxygen content in the liquid mixing tank is within 3%, lower the temperature to 50°C, add 300ml of water for injection, and then add 0.35g of tryptophan, stir and dissolve, replenish water to 1000ml, and obtain a mixed solution;...

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Abstract

The invention provides a preparation method of a compound amino acid injection. The preparation method comprises the following steps: respectively washing a preparation container and a pipeline with alkaline water, a metal ion chelating agent solution and water for injection; putting the water for injection into a liquid preparation tank, adding sodium hydroxide, and stirring while adding until the sodium hydroxide is dissolved; introducing N2 into the liquid preparation tank, then sequentially adding tyrosine, isoleucine, leucine, lysine hydrochloride, methionine, threonine, valine, alanine,arginine hydrochloride, aspartic acid, glutamic acid, proline, serine, glycine, phenylalanine, histidine hydrochloride, xylitol and cysteine hydrochloride, and stirring and dissolving one by one; continuously introducing N2 into the liquid preparation tank, ensuring that the oxygen content is within 3%, cooling the materials, adding water for injection, adding tryptophan, stirring, dissolving, andsupplementing water to a full amount to obtain a mixed solution; and filtering and sterilizing the mixed solution, injecting the mixed solution into an infusion bottle, capping and sealing the bottle, and performing sterilizing and performing light inspection to obtain the compound amino acid injection.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical products, in particular to a compound amino acid injection and a preparation method thereof. Background technique [0002] Compound amino acid injection (18AA-V) is generally composed of 18 kinds of amino acids such as tryptophan, leucine, isoleucine, valine, methionine, phenylalanine and other compound preparations, mainly used for protein Patients with insufficient intake, malabsorption and other amino acids that cannot meet the body's metabolic needs can also be used to improve the nutritional status of patients after surgery. [0003] Amino acids are very unstable in solution and are easily oxidized to produce a series of complex substances harmful to the human body. Among them, the most obvious problem that affects product quality is the degradation of tryptophan in the preparation during the process. The main degradation products of tryptophan are 5-hydroxytryptophan, 2-hydroxytrypto...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K31/405A61K31/198A61K31/4172A61K31/401A61P3/02
CPCA61K9/0019A61K9/08A61K31/198A61K31/401A61K31/405A61K31/4172A61K47/26A61P3/02A61K2300/00
Inventor 何凯峰祝丽敏李琳冯建生陈凤
Owner 武汉久安药业有限公司
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