Compound amino acid injecta, and preparation method and detection method thereof

Abstract

The invention discloses compound amino acid injecta, which contains arginine hydrochloride, histidine monohydrochloride, leucine, isoleucine, lysine hydrochloride and the like; meanwhile, the invention further discloses a preparation method of the compound amino acid injecta (18AA); in the event of ensuring the product quality, the compound amino acid injecta has the characteristics of saving energy and enhancing efficacy; by means of repetitive verification on precision, detection limit, quantitation limit, linear range and the like, a simple, convenient, rapid and reliable method with cleaning verification is ensured; furthermore, the residual quantity of antioxygen, namely sodium hydrogensulfite, in the compound amino acid injecta and sulphate ion generated by degrading sodium hydrogensulfite are detected according to an ion chromatography principle, thus, the amount of the antioxygen charged in the raw material proportioning can be accurately measured, and the stability of the raw material proportioning process is judged according to the measurement result; and a detection method of the compound amino acid injecta provided by the invention is an online derivative amino acid content measuring method, the speed is rapid, and the method is applied to large-scale detection.

Description

technical field [0001] The invention relates to an injection and a preparation method and a detection method thereof, in particular to a compound amino acid injection and a preparation method and a detection method thereof. Background technique [0002] Compound Amino Acid Injection (18AA) is an amino acid infusion. Under the condition of sufficient energy supply, it participates in the synthesis and metabolism of protein, obtains positive nitrogen balance, and generates enzymes, hormones, antibodies and structural proteins, promotes tissue healing and restores normal physiological functions It is mainly suitable for patients with protein deficiency of total parenteral nutrition and severe protein loss caused by various reasons such as surgery and burns. [0003] At present, the production process of compound amino acid injection (18AA) is mostly based on the solubility, and the intolerant amino acid is injected first, and then the soluble amino acid is injected after it dis...

AI Technical Summary

Problems solved by technology

PITC method and AQC method require manual derivation, complicated operation, poor durability of chromatographic conditions, mobile phase adjustment almost every time, and some amino acids are poorly separated; OPA / FMOC method can be automatically derivatized, but mobile phase preparation is complicated, and some The separation of amino acids is not good, especially histidine and glycine. After several samples of the chromatographic column, the resolution is less than 1.0, and the life of the chromatographic column is very short. It will be damaged after continuous use for less than one month; Dinitrofluorobenzene is an explosive and highly toxic substance with strong carcinogenicity, and this method has high requirements on the chromatographic column and is easy to damage the chromatographic column. Determination; the ninhydrin method is less and less used due to the complex structure of the instrument, high price, poor sensitivity, long analysis time, proline cannot be detected, etc.

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