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Pharmaceutical composition and purpose of compound amino acid injection 18AA-V

A technology of 18AA-V and compound amino acids, which is applied in drug combination, drug delivery, medical preparations containing active ingredients, etc., and can solve problems such as unusable diseases, acid-base imbalance, and adverse problems

Inactive Publication Date: 2014-09-03
刘力
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compound amino acid injection (18AA-V) as an amino acid drug (National Drug Standard WS 1 -(X-324)-2003Z), used for patients with insufficient protein intake, malabsorption and other amino acids that cannot meet the metabolic needs of the body, and also used to improve the nutritional status of patients after surgery, but the existing preparations may be injected into the body in some cases Lead to acid-base imbalance or other adverse reactions or restrictions on indications, etc., resulting in the inability to use some diseases or unexpected adverse problems after use, or restricting the clinical selectivity of the drug or the drug, making It becomes the focus of or object of study in pharmacy or pharmacology or related disciplines

Method used

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  • Pharmaceutical composition and purpose of compound amino acid injection 18AA-V
  • Pharmaceutical composition and purpose of compound amino acid injection 18AA-V
  • Pharmaceutical composition and purpose of compound amino acid injection 18AA-V

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0251] Embodiment 1, the preparation of compound amino acid injection (18AA-V), prescription:

[0252]

[0253] Preparation Process:

[0254] Weigh each raw material and auxiliary material according to the prescription; add 8000ml of water for injection into the dispensing tank, heat to boil, repeatedly vacuumize and replace with nitrogen to reduce the oxygen content in the dispensing tank, and then fill the tank with nitrogen during the whole process. Add raw and auxiliary materials sequentially between 96°C and 85°C: xylitol, antioxidant (sodium bisulfite), L-tyrosine, L-leucine, L-isoleucine, L-valine , L-methionine, stir until fully dissolved, and put L-phenylalanine, L-glutamic acid, and L-asparagine into the above-mentioned liquid mixing tank in sequence when the liquid temperature drops to 85°C°-65°C amino acid, L-lysine acetate, L-threonine, glycine, L-arginine, L-alanine, L-proline, L-serine, stir until completely dissolved, and wait until the solution temperatur...

Embodiment 2

[0255] Refer to drug standard WS 1 -(X-324)-2003Z measures the content of each amino acid and xylitol in the pharmaceutical composition of the present invention that has been kept at room temperature for 3 months, and finds that they are all within the scope of 90-110% of the marked amount of the prescription; According to the determination, the sodium ion content in the solution is lower than 25mmol / L. In addition, the properties of the solution, insoluble particles, light transmittance, pH value, etc. are in line with the Chinese Pharmacopoeia 2010 version or the drug standard WS 1 - Regulations of (X-324)-2003Z. Embodiment 2, the preparation of compound amino acid injection (18AA-V), prescription:

[0256]

[0257]

[0258] Preparation Process:

[0259] Weigh each raw material and auxiliary material according to the prescription; add 7500ml of water for injection into the dispensing tank, heat and boil, and repeatedly adopt vacuum pumping and nitrogen filling repla...

Embodiment 3

[0261] Embodiment 3, the preparation of compound amino acid injection (18AA-V), prescription:

[0262]

[0263]

[0264] Preparation Process:

[0265] Weigh each raw material and auxiliary material according to the prescription; 1), add the prescribed amount of sorbitol into a batching bucket, add 1000ml of water for injection, stir to dissolve, add 0.3 g of activated carbon, stir, heat and boil for 20 minutes, and cool to 65-80°C , nitrogen flow for 20 minutes, stand-by; 2), add 7000ml of water for injection in the concentrated mixing tank, fill nitrogen while heating, add antioxidant (edetate calcium sodium, citric acid) when 95-90 ℃, stir Make it dissolve, then add L-tyrosine, L-leucine, L-isoleucine, L-valine, methionine stirring and dissolving of recipe quantity; 3), under nitrogen protection condition, Cool the solution obtained in step 2) to 65-75°C, add prescription quantities of L-phenylalanine, L-glutamic acid, L-aspartic acid, L-lysine acetate, L-threonine, ...

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Abstract

The invention provides a novel pharmaceutical composition of compound amino acid injection (18AA-V). The pharmaceutical composition provided by the invention can be used for the preparation of medicaments for patients with inadequate protein intake and absorption obstacle, resulting in that amino acid can not meet the need of body metabolism and for improving the nutritional status of post operation patients, and preparation of medicaments for prevention or treatment of metabolic acidosis; and the obtained product has new intended population or better pertinency and clinical safety in clinical application.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular, it is provided for patients whose amino acids cannot meet the metabolic needs of the body, such as insufficient protein intake and malabsorption. The pharmaceutical composition of the compound amino acid injection (18AA-V), which is also used to improve the nutritional status of patients after surgery, and its preparation and use. The product of the present invention is more suitable for patients who need to supplement 18AA-V amino acid injection under many diseases or symptoms such as metabolic acidosis or hyperchloremic metabolic acidosis, and the product of the present invention has wider safety in clinical use Or more or updated indications or adapted populations, etc. Background technique [0002] Protein is the main component of cell structure. The basic unit of protein structure is amino acid. The human body needs to take in a certain amount of protein every day to meet th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K9/08A61P3/02A61P3/12
Inventor 刘力
Owner 刘力
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