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Lovamin and its prepn process

A kind of happy life, compound technology, applied in the field of compound amino acid injection, can solve the problems of limiting the clinical application of compound amino acid injection, unable to produce no or containing sulfite, and the curative effect cannot be guaranteed.

Inactive Publication Date: 2002-09-25
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, patients and doctors face a dilemma: either reduce the dose of amino acid solution to reduce the occurrence of side effects, but the curative effect cannot be guaranteed;
This situation greatly limits the clinical application of compound amino acid injection, an important drug.
[0010] The reason why the national drug quality standards do not strictly control the content of sulfite is that the substance has irreplaceable and superior antioxidant capacity. Under the current technical conditions, it is still impossible to produce sulfite-free or containing Compound Amino Acid Injection with Minimal Salt

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0029] Example 1 Levantine 8.5% with 0.001% Sodium Bisulfite, 1000ml

[0030] Element

quantity

18 kinds of ammonia including L-alanine

amino acid

85 grams

sodium bisulfite

0.01g

Glacial acetic acid

2.5ml

Water for Injection

940 grams

[0031] production method:

[0032] 1. Preparation

[0033] Take a three-neck bottle with a capacity of 2000 to 3000 ml, which is respectively connected with a vacuum system with valve control, a nitrogen pipeline, and a water for injection pipeline, and is equipped with a magnetic stirring device. Add 18 kinds of amino acids such as 85 grams of powdery L-alanine, 0.01 gram of sodium bisulfite in this three-necked bottle. Turn on the vacuum pump to make the vacuum in the bottle reach -0.085~-0.09 MPa, and fill it with nitrogen with a purity of 99.999% to normal pressure. Repeat the operation three times to ensure that the oxygen content in the bottle is lower than 0.1%. ...

example 2

[0038] Example 2 Levantine 8.5% containing 0.002% sodium bisulfite, 1000ml

[0039] Element

quantity

18 kinds of ammonia including L-alanine

amino acid

85 grams

sodium bisulfite

0.02 grams

Glacial acetic acid

2.5ml

Water for Injection

940 grams

[0040] production method:

[0041] 1. Preparation

[0042] Take a three-neck bottle with a capacity of 2000 to 3000 ml, which is respectively connected with a vacuum system with valve control, a nitrogen pipeline, and a water for injection pipeline, and is equipped with a magnetic stirring device. Add 18 kinds of amino acids such as 85 grams of powdery L-alanine, 0.02 gram of sodium bisulfite in this three-necked bottle. Turn on the vacuum pump to make the vacuum in the bottle reach -0.085~-0.09 MPa, and fill it with nitrogen with a purity of 99.999% to normal pressure. Repeat the operation three times to ensure that the oxygen content in the bottle is lower t...

example 3

[0047] Example 3 Levantine 8.5% containing 0.003% sodium bisulfite, 1000 ml

[0048] Element

quantity

18 kinds of ammonia including L-alanine

amino acid

85 grams

sodium bisulfite

0.03 grams

Glacial acetic acid

2.5ml

Water for Injection

940 grams

[0049] production method:

[0050] 1. Preparation

[0051] Take a three-neck bottle with a capacity of 2000 to 3000 ml, which is respectively connected with a vacuum system with valve control, a nitrogen pipeline, and a water for injection pipeline, and is equipped with a magnetic stirring device. Add 18 kinds of amino acids such as 85 grams of powdered L-alanine, 0.03 grams of sodium bisulfite in this three-necked bottle. Turn on the vacuum pump to make the vacuum in the bottle reach -0.085~-0.09 MPa, and fill it with nitrogen with a purity of 99.999% to normal pressure. Repeat the operation three times to ensure that the oxygen content in the bottle is lowe...

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PUM

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Abstract

The present invention belongs to one mixed amino acid injection containing 18 kinds of amino acids and is named Lovamin. Its main components includes 18 kinds of amino acids in 8.5 wt% or 11.4 wt%, sulfite in 0.001-0.003 wt% and glacial acetic acid in small amount other than injection water. Its preparation process includes the steps of compounding of injection, filling and disinfecting in a steam sterilizer. Compared with similar product, the present invention has less side effect.

Description

technical field [0001] The invention belongs to a compound amino acid injection containing 18 kinds of amino acids—commonly known as Lefanming and its manufacturing method. Background technique [0002] Proteins are the building blocks of cellular structures, act as biochemical catalysts, and are important regulators of gene expression. The basic unit of protein structure is the amino acid. The human body needs to take in a certain amount of protein every day to meet the needs of life activities. When it cannot take in enough amount from the gastrointestinal tract for some reason, it must be supplemented by intravenous amino acid solution. The compound amino acid injection containing 18 kinds of amino acids is a very important amino acid supplement and plays an important role in clinical practice. [0003] Amino acids are very unstable in solution and are easily oxidized to produce a series of complex substances harmful to the human body. Since compound amino acids were p...

Claims

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Application Information

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IPC IPC(8): A61K31/195A61P3/02
Inventor 马涛
Owner 费森尤斯卡比华瑞制药有限公司
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