Compound amino acid dipeptide injection as well as 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

CN110548129AActive Publication Date: 2019-12-10ZHONGSHAN HOSPITAL FUDAN UNIV
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2019-12-10

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Abstract

The invention belongs to the field of medicines and provides compound amino acid dipeptide injection as well as a preparation method and application thereof. The injection comprises three cavity bags;the three cavity bags adopt three spaced chambers in which a branched-chain amino acid solution, an L-alanyl-L-glutamine solution and a mixed solution containing arginine hydrochloride and vitamin B6are accommodated correspondingly; in each 1000 mL of injection, the total mass of the amino acid is 50 to 130 g; the branched-chain amino acid accounts for 10 to 80 percent of the total mass of the amino acid; the L-alanyl-L-glutamine accounts for 5 to 70 percent of the total mass of the amino acid; the arginine hydrochloride accounts for 0 to 50 percent of the total mass of the amino acid; and the mass of the vitamin B6 is 0 to 1 g. The injection provided by the invention improves product stability and effectiveness while providing product safety; and the technical scheme is simple and convenient and is favorable for industrialized production.
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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...

Examples

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...