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Preparation method of compound amino acid injection

A compound amino acid and injection technology, which is applied in the field of preparation of compound amino acid injection, can solve problems such as oxygen isolation and poor solubility, decreased amino acid content, and yellowing of liquid color, and achieves easy operation by production personnel, low preparation temperature, The effect of short preparation time

Active Publication Date: 2012-01-04
HUAREN PHARMACEUTICAL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The invention provides a preparation method of compound amino acid injection, which solves the problems encountered in the preparation process of the above-mentioned compound amino acid injection that need to pay attention to oxygen isolation and poor solubility, etc.
The present invention first adopts the treatment of vacuumizing and filling nitrogen during the preparation process of the injection to drive away the oxygen in the preparation equipment and the dissolved oxygen dissolved in water, and solves the problem of oxygen re-dissolving in the preparation process, and can avoid compounding In the process of long-term storage of amino acid injection, the color of the liquid turns yellow and the amino acid content decreases due to oxidation; at the same time, the preparation method of the present invention uses cystine, the most insoluble amino acid component, alone with low The concentrated lye is dissolved first and then fed, and the rest of the amino acid components are fed at one time, without the need to divide each component into multiple groups or feed at high temperature

Method used

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  • Preparation method of compound amino acid injection
  • Preparation method of compound amino acid injection
  • Preparation method of compound amino acid injection

Examples

Experimental program
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Embodiment 1

[0027] Follow the steps below to prepare compound amino acid injection:

[0028] (1) Weigh the following components according to the formula quantity of each 1000ml compound amino acid injection mentioned above:

[0029]

[0030] (2) Turn on the vacuum pump and vacuumize the production equipment. The production equipment includes a preparation container and a pipeline system, until the vacuum degree reaches below -0.1MPa, fill nitrogen with a purity ≥ 99.9% to a positive pressure, and repeat the operation three times.

[0031] (3) Close the valve between the preparation container and the pipeline system, add 60% of the total amount of 65°C water for injection into the preparation container, and then vacuumize it until the vacuum degree reaches below -0.1MPa, and fill it with a purity ≥ 99.9% nitrogen to positive pressure, repeat the operation three times, under the condition of constantly filling the container with nitrogen to maintain the positive pressure, put into the so...

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Abstract

The invention provides a preparation method of a compound amino acid injection. Due to the adoption of vacuumization and nitrogen injection in an injection preparation process, oxygen in preparation equipment and water-soluble dissolved oxygen are removed, and the problems that amino acid is instable and is vulnerable to oxidizing in a solution so as to enable the color of the liquid medicine to turn yellow and the content of the amino acid to be decreased are solved. The preparation method provided by the invention is characterized in that the most insoluble amino acid composition, i.e. cystine, is dissolved by low-concentration alkali liquor independently and then is subjected to batch feeding, other amino acid components are subjected to batch feeding at a time, and multi-group batch feeding or high-temperature batch feeding of each component is not needed; and the preparation method has the advantages of simple and convenient batch feeding way, low preparation temperature, short preparation time and the like, has lower requirement on production facilities, and can be easily operated by production staff.

Description

technical field [0001] The invention relates to a preparation method of compound amino acid injection containing 18 kinds of amino acids. 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. At present, the clinically used intravenous hypernutrients mainly include hydrolyzed protein and compound amino acid infusion. 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. At present, the preparation process of amino acid injection is relatively complicated...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K31/405A61K31/401A61K31/198A61K9/08A61P3/02
Inventor 孙玮邹姗姗吴强王振恒
Owner HUAREN PHARMACEUTICAL CO LTD
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