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Pharmaceutical composition containing 19 types of amino acids and preparation method thereof

A composition and 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 19 kinds of amino acids all contain antioxidants, which cause defects such as various adverse reactions. Therefore, the present invention provides a pharmaceutical composition containing 19 kinds of amino acids and its The preparation method, the pharmaceutical composition does not contain sulfites, 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 19 types of amino acids and preparation method thereof
  • Pharmaceutical composition containing 19 types of amino acids and preparation method thereof
  • Pharmaceutical composition containing 19 types of amino acids and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] Embodiment 1 The preparation of comprehensive amino acid injection for children's TPN

[0122] The components and dosage of the comprehensive amino acid injection for children's TPN are shown in the table below:

[0123] Isoleucine

8.00g

Histidine

2.50g

Leucine

16.00g

Glycine

2.00g

Lysine acetate

6.77g

Alanine

5.20g

Methionine

1.50g

glutamic acid

0.80g

Phenylalanine

2.50g

aspartic acid

0.80g

threonine

2.40g

proline

6.00g

Tryptophan

1.20g

serine

4.00g

Valine

6.00g

Tyrosine

0.60g

arginine

10.00g

cysteine

1.50g

taurine

0.20g

0.1mol / L acetic acid solution

Appropriate amount

Water for Injection

Appropriate amount

[0124] The total amount is 1000ml.

[0125] Preparation:

[0126] (1) Weigh each raw material and auxiliary material according to the prescription;

[0127] (2) Take 70...

Embodiment 2

[0133] Embodiment 2 Preparation of comprehensive amino acid injection for children's TPN

[0134] The components and dosage of the comprehensive amino acid injection for children's TPN are shown in the table below:

[0135]

[0136]

[0137] The total amount is 1000ml.

[0138] Preparation:

[0139] (1) Weigh each raw material and auxiliary material according to the prescription;

[0140] (2) Take 70% of the total amount of water for injection, keep the water temperature at 80° C., carry out nitrogen replacement operations on the reactor for 3 times, and feed nitrogen into the reactor for heat preservation.

[0141] (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.

[0142] (4) Under the protection of nitrogen flow, cool down to 45°C, add the prescribed amount of threonine, proline, glutamic acid,...

Embodiment 3

[0146] Embodiment 3 Preparation of comprehensive amino acid injection for children's TPN

[0147] The components and dosage of the comprehensive amino acid injection for children's TPN are shown in the table below:

[0148]

[0149]

[0150] The total amount is 1000ml.

[0151] Preparation:

[0152] (1) Weigh each raw material and auxiliary material according to the prescription;

[0153] (2) Take 70% of the total amount of water for injection, keep the water temperature at 80° C., carry out nitrogen replacement operations on the reactor for 3 times, and feed nitrogen into the reactor for heat preservation.

[0154] (3) Under the protection of nitrogen flow, monitor the dissolved oxygen below 1.5mg / L, add the prescribed amount of tyrosine, leucine, isoleucine, valine, aspartic acid, phenylalanine and Methionine. Stir until dissolved.

[0155] (4) Under the protection of nitrogen flow, cool down to 45°C, add the prescribed amount of threonine, proline, glutamic acid,...

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Abstract

The invention discloses a pharmaceutical composition containing 19 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, taurine, a pH value 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 19 kinds of amino acids and a preparation method thereof. Background technique [0002] Comprehensive Amino Acid Injection for Children TPN is a sterilized aqueous solution prepared from 19 kinds of amino acids plus auxiliary materials. It is clinically used for amino acid supplementation before and after surgery in patients with acute and chronic renal insufficiency in hypoproteinemia, low nutritional status and surgery. [0003] The Japan Pharmacy Bureau standard "(7AM) 524" stipulates that comprehensive amino acid injection for children TPN should contain 0.30g of sodium bisulfite per liter of amino acid injection. [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 met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61K31/405A61K31/4172A61K31/401A61K31/185A61P3/02
CPCA61K47/12A61K9/0019A61K9/08A61K31/185A61K31/198A61K31/401A61K31/405A61K31/4172A61K2300/00
Inventor 饶萌韩芳高芳马岭
Owner 湖北一半天制药有限公司
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