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A kind of compound amino acid injection 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 problems such as unreasonableness, and achieve the effects of good effect, elimination of side effects and alleviation of degradation

Active Publication Date: 2016-06-29
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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  • A kind of compound amino acid injection 18aa-v composition and preparation method thereof
  • A kind of compound amino acid injection 18aa-v composition and preparation method thereof
  • A kind of compound amino acid injection 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, which is characterized in that every 1000 mL injection contains the following components:

[0053]

[0054]

[0055] Add water for injection to 1000mL;

[0056] The pH of the injection is 6.2;

[0057] The method for preparing the compound amino acid injection 18AA-V, the steps are:

[0058] A. Add 700mL of fresh water for injection into the liquid preparation tank, pour in pure nitrogen, turn on the stirring, and reserve. All the following preparations have been protected by nitrogen.

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

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

[0061] D. After stirring and dissolving, cool to 60 or 64 or 68 or 75°C, add threonine, glycine, lysine hydrochloride, and xylitol in sequence, and ...

Embodiment 2-7

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

[0070]

[0071]

[0072] The preparation methods are the same as in Example 1.

[0073] The technical scheme of the present invention is further explained through the following related tests:

[0074] 1. The stability comparison test of the product obtained in Example 1 of similar products containing sodium bisulfite on the market:

[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 (adding 0.05% (w / v) sodium bisulfite, adjusting the pH 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 follows:

[0077]

[0078] A...

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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 technical field of medicine, 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 present invention is suitable for nutrition Nutritional support for patients with dysfunction, hypoproteinemia and before and after surgery. Background technique [0002] Compound Amino Acid Injection (18AA-Ⅴ) is a parenteral nutrition medicine, which is a sterile aqueous solution prepared from 18 amino acids and xylitol. It is a balanced amino acid injection and has an extremely important position in clinical applications. The composition conforms to the Vuj-N formula ratio, the essential amino acids conform to the human milk-total protein model, and the non-essential amino acids conform to the human serum protein model. The ratio of essential amino acids to non-essential amino acids is 1.04:1. Each amino aci...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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