Compound 18-amino acid injection containing little amount of antioxidant and preparation method thereof

Abstract

The invention relates to a compound 18-amino acid injection containing a little amount of antioxidant and a preparation method thereof. The injection contains 0.0005w / v% to 0.005w / v% of sodium hydrogen sulfite or sodium metabisulfite or mixture which is compounded with 18 kinds of amino acids and water for injection, wherein the content of dissolved oxygen in the injection is not greater than 0.1ppm (parts per million). The preparation method comprises the following steps of: 1) preparing: putting 18 kinds of compound amino acids, the sodium hydrogen sulfite or the sodium metabisulfiteor or the mixture into a tank by filling nitrogen ceaselessly under the conditions that content of oxygen in the tank is lower than 0.1% and the content of the dissolved oxygen contained in the injection is not greater than 0.1ppm; 2) filling and sealing; and 3) sterilizing. By optimizing a production process, the oxygen content of a medicine liquid and the oxygen content of a headspace are reduced fundamentally, so that the content of the sodium bisulfite / the sodium metabisulfite which is added for ensuring that the medicine liquid is not oxidized is reduced. Thus, the compound amino acid injection which can be well tolerated by a patient is produced, namely, the safety of the injection is improved. Therefore, the phenomenon that a sufficient dose of the injection cannot be accepted by the patient because the patient is worry about toxic and side effects is avoided. As a result, the injection provided by the invention has the great significance for guaranteeing the living and the life quality of the patient.

Description

Technical field [0001] The invention relates to an eighteenth compound amino acid injection, in particular to an eighteenth compound amino acid injection containing a small amount of antioxidants. Background technique [0002] 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 the needs of life activities. When the gastrointestinal tract is not enough for some reason, it must be supplemented by intravenous infusion of amino acid solution. Compound amino acid injection (18AA) is Very important amino acid supplements and therapeutic agents play 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 put into production in the 1960s, in order to ensure product stability, sulfite compounds with unique antioxidant properties, such as sodium bisulfite ...

AI Technical Summary

Problems solved by technology

Therefore, patients and doctors are faced with a dilemma. If the dosage of amino acid injection is reduced in order to reduce the occurrence of toxic and side effects, the desired curative effect cannot be achieved.

[0006] For now, the antioxidant capacity of sulfite is irreplaceable in the compound amino acid injection (18AA); as far as the current technical conditions are concerned, it is still impossible to produce a compound that does not contain or contains very little sulfite Amino Acid Injection (18AA)

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