Compound amino acid dipeptide injection and preparation method and application thereof

A compound amino acid and injection technology, applied in the field of biomedicine, can solve problems such as inability to adapt to patient material energy metabolism, easy oxidation of amino acids, malignant laryngeal edema, etc., to reduce risks and the probability of allergic reactions, and damage liver and kidney Function, intestinal protection effect

Inactive Publication Date: 2019-11-05
ZHONGSHAN HOSPITAL FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, amino acid injections currently available on the market are not aimed at such perioperative anesthesia patients (preoperative, intraoperative, and early postoperative) and cannot meet the needs of such patients for material and energy metabolism.
In the prior art, there is a lack of technical solutions for infusion of compound amino acid injection during perioperative anesthesia, and the infusion of energy substances (amino acids, fats) other than glucose is considered when the patient is still unable to eat effectively 7-10 days after the operation. , which may miss the best opportunity to improve the body's material and energy metabolism, enhance the body's immunity, and promote the body's wound healing
[0004] In addition, in clinical use, mixing multiple components together to prepare injections often requires the addition of a large amount of additives to maintain the stability of the injection, but the addition of additives may cause adverse reactions
Most of the amino acid injections currently on the market contain antioxidants such as sodium bisulfite, sodium metabisulfite, etc. Although the existence of sulfite solves the problem that amino acids are easily oxidized, it can also cause common side effects, such as bronchial Convulsions, dyspnea, malignant laryngeal edema, hypotension, shock, etc.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1~6

[0037] 1. Prescription: the prescription of embodiment 1~6 is as shown in table 1 below:

[0038] Table 1

[0039]

[0040]

[0041] 2. Preparation method

[0042] According to the prescription ratio of Examples 1-6, the above-mentioned components are added one by one in the water for injection at 40-95 °C deoxygenated in advance, and then in N 2 Stir under protection until the components of the drug are completely dissolved, and control the dissolved O in the liquid. 2 The concentration should not be higher than 1ppm, and then add the above liquids respectively to the pre-vacuumized and filled with N 2 In a three-chamber packaging bag, add water to the volume and then seal it. Among them, based on a total of 1000mL, the three chambers are respectively filled with 100-925mL of branched-chain amino acid solution and 25mL of L-alanyl-L-glutamine solution. ~400mL and 0~500mL mixed solution containing arginine hydrochloride and vitamin B6; and the pH values ​​of the three...

experiment example

[0053] 1. Stability experiment

[0054] Taking Example 1 and Comparative Example 1, and Example 6 and Comparative Example 6 as examples respectively, the prepared injection was stored in a cool and dark place for 0 to 6 months. The experimental results are shown in Tables 3 and 4 below:

[0055] Table 3 embodiment 1 and comparative example 1 injection stability experiment

[0056]

[0057]

[0058] It can be seen that the stability of Example 1 and Comparative Example 1 all meet the requirements, and the stability of Example 1 is better.

[0059] Table 4 embodiment 6 and comparative example 6 injection stability experiment

[0060]

[0061]

[0062] It can be seen that the stability of Example 6 and Comparative Example 6 all meet the requirements, and the stability of Example 6 is better.

[0063] 2. Vascular irritation test

[0064] Vascular irritation test result shows, embodiment 1,6, comparative example 1 rabbit's marginal ear vein test experiment shows that...

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Abstract

The invention belongs to the field of medicine, and provides a compound amino acid dipeptide injection, a preparation method thereof and an application thereof, the injection comprises three cavity bags, the three cavity bags are respectively separated by three bags and filled with a branched-chain amino acid solution, a L-alanyl-L-glutamine solution, and a mixed solution containing arginine hydrochloride and vitamin B6; wherein, in every 1000 mL of the injection solution, the total mass of the amino acid is 50 g to 130 g; and the branched chain amino acid mass accounts for 10 to 80% of the total mass of the amino acid; the mass of L-alanyl-L-glutamine is 5 to 70% of the total mass of the amino acid; the mass of arginine hydrochloride is 0 to 50% of the total mass of the amino acid; and the mass of the vitamin B6 is 0 to 1 g. The injection of the invention improves the stability and effectiveness of the product while providing product safety, and the technical scheme is simple and convenient for industrial production.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a compound amino acid dipeptide injection and its preparation method and application. Background technique [0002] Amino acid is the basic unit of protein molecules in organisms. It is closely related to the life activities of organisms. It is one of the essential nutrients in organisms. The digestion and absorption of protein in the body is completed through amino acids. The need for amino acids is actually the need for amino acids. Hypoproteinemia is the result of negative nitrogen balance caused by various reasons. The main causes are: insufficient protein intake or malabsorption, loss of appetite and anorexia caused by various reasons; Hepatic protein synthesis ability is reduced, plasma protein synthesis is reduced, a large amount of protein is lost for a long time; protein decomposition is accelerated, etc. A variety of amino acids (including dipeptides, etc.) are pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/08A61J1/10A61P1/00A61P3/00A61P21/00A61P37/04A61P39/00A61K31/047A61K31/198A61K31/4415
CPCA61J1/10A61K9/0019A61K9/08A61K38/05A61K31/198A61K31/4415A61P1/00A61P37/04A61P3/00A61P21/00A61P39/00A61K31/047A61K2300/00Y02A50/30
Inventor 葛圣金
Owner ZHONGSHAN HOSPITAL FUDAN UNIV
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