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Compound amino acid injection solution 18AA-V composition and preparation method thereof

A technology of 18AA-V and compound amino acid, which is applied in the field of preparation of compound amino acid injection (18AA-V) composition, can solve unreasonable problems, achieve good effect, eliminate side effects, and ease degradation

Active Publication Date: 2014-05-21
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

In addition, compound amino acid injection (18AA-V) contains several amino acid hydrochlorides such as arginine hydrochloride, histidine hydrochloride, histidine hydrochloride and cysteine ​​hydrochloride. The pH value of the solution is already close to 5.5. It is obviously unreasonable to adjust the pH value with citric acid

Method used

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  • Compound amino acid injection solution 18AA-V composition and preparation method thereof
  • Compound amino acid injection solution 18AA-V composition and preparation method thereof
  • Compound amino acid injection solution 18AA-V composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] A compound amino acid injection 18AA-V composition, characterized in that every 1000mL injection contains the following components:

[0053]

[0054]

[0055] Add water for injection to 1000mL;

[0056] The pH value of the injection is 6.2;

[0057] The preparation method of above-mentioned compound amino acid injection 18AA-V, its steps are:

[0058] A. Add 700mL of fresh water for injection into the liquid preparation tank, inject pure nitrogen gas, start stirring, and set aside for later use. Nitrogen gas protection is always used in the following preparation processes.

[0059] B. Heat to 90 or 92 or 94 or 95°C, add tyrosine, after dissolving, add methionine, leucine, isoleucine, valine in sequence, stir to dissolve.

[0060] C. After stirring to dissolve, lower the temperature to 80 or 81 or 83 or 84 or 85°C, add glutamic acid and phenylalanine, and stir to dissolve.

[0061] D. After stirring to dissolve, lower the temperature to 60 or 64 or 68 or 75°C, a...

Embodiment 2-7

[0069] A compound amino acid injection 18AA-V composition, characterized in that each 1000mL injection contains the following components, for convenience, the pH value of each formulation composition is written in the last line:

[0070]

[0071]

[0072] Its preparation method is all identical with embodiment 1.

[0073] The technical scheme of the present invention will be further described by following related tests:

[0074] One, the stability comparative test of the similar product containing sodium bisulfite commercially available of embodiment 1 gained product:

[0075] The product obtained in Example 1 is the test group, and the commercially available compound amino acid injection (18AA-V) is used as the control group (add 0.05% (w / v) sodium bisulfite, and adjust the pH value of the solution to about 6.2 with sodium hydroxide) .

[0076] The prescription of the commercially available compound amino acid injection (18AA-V) containing sodium bisulfite is as follo...

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Abstract

The invention belongs to the technical field of medicines and particularly discloses a compound amino acid injection solution 18AA-V composition. The composition is composed of following components: arginine hydrochloride, histidine hydrochloride, leucine, isoleucine, lysine hydrochloride, phenylalanine, threonine, valine, methionine, tryptophan, glycine, alanine, proline, tyrosine, serine, cysteine hydrochloride, aspartate, glutamic acid, xylitol, malate and injection water; the composition does not contain a sulfite antioxidant; the malate is used as a pH (Potential Hydrogen) value adjusting agent, a metal ion chelating agent or a stabilizing agent; the bioavailability of various amino acids can also be improved; the cysteine hydrochloride is used as the antioxidant; nitrogen is filled in the whole production process to reduce the residual oxygen in the product, so that the quality of the product is better than that of similar compound amino acid injection solution products available on the market and the clinical utilization is safer.

Description

technical field [0001] The present invention relates to the field of medical technology, more specifically to a compound amino acid injection (18AA-V) composition, and also to a preparation method of a compound amino acid injection (18AA-V) composition. The product of the invention is suitable for nutrition Nutritional support for patients with malnutrition, hypoalbuminemia and before and after surgery. Background technique [0002] Compound Amino Acid Injection (18AA-Ⅴ) is a parenteral nutrition drug, which is a sterilized aqueous solution prepared from 18 kinds of amino acids and xylitol. It is a balanced amino acid injection and plays an extremely important role in clinical application. The composition conforms to the Vuj-N formula ratio, the essential amino acids conform to the human milk-whole protein mode, and the non-essential amino acids conform to the human serum protein mode. The ratio of essential amino acids to non-essential amino acids is 1.04:1, each amino ac...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K9/08A61K47/12A61P3/02A61P7/00A61K31/405A61K31/401A61K31/198A61K31/195
Inventor 李金屏甘周阳
Owner 湖北一半天制药有限公司
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