Pharmaceutical composition containing 18 types of amino acids and preparation method thereof

A composition, amino acid technology, applied in the field of medicine, can solve problems such as adverse reactions

Active Publication Date: 2019-02-26
湖北一半天制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The technical problem to be solved by the present invention is that the existing pharmaceutical compositions of 18 kinds of amino acids all contain antioxidants, which cause defects such as various adverse reactions. Therefore, the present invention provides a pharmaceutical composition containing 18 kinds of amino acids and its According to the preparation method, the pharmaceutical composition does not contain sulfite antioxidants, so it can completely eliminate the potential safety hazards of sulfites to the human body, making clinical use safer, and at the same time, its effective period is longer

Method used

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  • Pharmaceutical composition containing 18 types of amino acids and preparation method thereof
  • Pharmaceutical composition containing 18 types of amino acids and preparation method thereof
  • Pharmaceutical composition containing 18 types of amino acids and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0119] The preparation of embodiment 1 compound amino acid injection 18AA

[0120] The components and dosages of Compound Amino Acid Injection 18AA are shown in the table below:

[0121] Tyrosine

0.50g

glutamic acid

0.25g

Leucine

10.00g

Lysine acetate

7.00g

Isoleucine

7.50g

arginine

3.00g

Phenylalanine

5.00g

Alanine

3.00g

aspartic acid

0.25g

Glycine

1.50g

Valine

7.50g

Histidine

2.50g

threonine

2.50g

serine

1.00g

proline

2.00g

Tryptophan

2.50g

Methionine

5.00g

cysteine

0.25g

0.1mol / L acetic acid solution

Appropriate amount

Water for Injection

Appropriate amount

[0122] The total amount is 1000ml.

[0123] Preparation:

[0124] (1) Weigh each raw material and auxiliary material according to the prescription;

[0125] (2) Take 70% of the total amount of water for injection, keep the water temperature a...

Embodiment 2

[0131] The preparation of embodiment 2 compound amino acid injection 18AA

[0132] The components and dosages of Compound Amino Acid Injection 18AA are shown in the table below:

[0133] Tyrosine

0.475g

glutamic acid

0.230g

Leucine

9.200g

Lysine acetate

6.440g

Isoleucine

6.900g

arginine

2.760g

Phenylalanine

4.750g

Alanine

2.760g

aspartic acid

0.230g

Glycine

1.380g

Valine

6.900g

Histidine

2.300g

threonine

2.300g

serine

0.920g

proline

1.840g

Tryptophan

2.300g

Methionine

4.600g

cysteine

0.230g

0.1mol / L sodium acetate solution

Appropriate amount

Water for Injection

Appropriate amount

[0134] The total amount is 1000ml.

[0135] Preparation:

[0136] (1) Weigh each raw material and auxiliary material according to the prescription;

[0137] (2) Take 70% of the total amount of water for injection, keep the...

Embodiment 3

[0143] The preparation of embodiment 3 compound amino acid injection 18AA

[0144] The components and dosages of Compound Amino Acid Injection 18AA are shown in the table below:

[0145]

[0146]

[0147] The total amount is 1000ml.

[0148] Preparation:

[0149] (1) Weigh each raw material and auxiliary material according to the prescription;

[0150] (2) Take 70% of the total amount of water for injection, keep the water temperature at 70° C., carry out nitrogen replacement operations on the reactor for 3 times, and feed nitrogen into the reactor for heat preservation.

[0151] (3) Under the protection of nitrogen flow, monitor the dissolved oxygen below 0.5mg / L, add the prescribed amount of tyrosine, leucine, isoleucine, valine, aspartic acid, phenylalanine and Methionine. Stir until dissolved.

[0152] (4) Under the protection of nitrogen flow, cool down to 40°C, add the prescribed amount of threonine, proline, glutamic acid, lysine acetate, arginine, alanine, g...

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Abstract

The invention discloses a pharmaceutical composition containing 18 types of amino acids and a preparation method thereof. The pharmaceutical composition comprises tyrosine, leucine, isoleucine, phenylalanine, aspartic acid, valine, threonine, proline, methionine, glutamic acid, lysine acetate, arginine, alanine, glycine, histidine, serine, tryptophan, cysteine, a pH conditioning agent, and water.The pharmaceutical composition can be free of sulfites, thereby completely eliminates the safety hazards of sulfites to the human body, and makes the clinical use safer; and the expiration period of the composition is longer.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing 18 kinds of amino acids and a preparation method thereof. Background technique [0002] Compound Amino Acid Injection (18AA-IX) is a sterilized aqueous solution prepared from 18 kinds of amino acids plus excipients. It is clinically used for amino acid supplementation in patients with acute and chronic renal insufficiency in hypoproteinemia, low nutritional status and before and after surgery. [0003] State Food and Drug Administration Standard WS1-XG-022-2011-2012 Compound Amino Acid Injection (18AA-IX) stipulates that every liter of (18AA-IX) injection contains 0.50 g of sodium bisulfite. [0004] The NDA number approved by the U.S. FDA is 19018, and the compound amino acid injection (19AA) with the trade name TrophAmine on March 24, 2004 has indicated that every 100 milliliters contains sodium metabisulfite less than 0.050 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K9/08A61P3/02A61K31/405A61K31/401A61K31/198
CPCA61K9/0019A61K9/08A61K31/198A61K31/401A61K31/405A61K31/4172A61K2300/00Y02A50/30
Inventor 甘丰瑞饶萌喻颖利甘周阳
Owner 湖北一半天制药有限公司
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