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Detection method of relevant substance in compound amino acid injection

A compound amino acid and injection technology, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot meet the requirements of substance detection, and the detection method of compound amino acid injection has not been recorded, so as to achieve the sensitivity of the method and improve the detection Good sensitivity and reproducibility

Active Publication Date: 2018-10-16
MEDICINE & BIOENG INST OF CHINESE ACAD OF MEDICAL SCI
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Problems solved by technology

However, the pharmacopoeias of various countries have not included the detection methods of related substances in compound amino acid injection
Although there are pharmacopoeias that record the detection methods of related substances in amino acid raw materials, these related substances are process impurities remaining in the amino acid production process, and most of them are endogenous amino acids, which are covered by other amino acid raw materials in the formula of compound preparations, so they cannot meet the requirements. Requirements for the detection of related substances in compound amino acid injection

Method used

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  • Detection method of relevant substance in compound amino acid injection
  • Detection method of relevant substance in compound amino acid injection
  • Detection method of relevant substance in compound amino acid injection

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Effect test

Embodiment 1

[0031] The detection of related substances in the compound amino acid injection of embodiment 1

[0032] 1. Instrument

[0033]Thermo dionex UltiMate 3000 high performance liquid chromatography (online degasser, double ternary gradient pump, DIONEX UltiMate 3000Diode Array Detector, DIONEX UltiMate 3000Autosampler, DIONEX UltiMate 3000Column Compartment, Chromeleon 7.2 chromatography workstation) (ThermoFisher, USA); XP205, METTLER TOLEDO company, Switzerland); Milli-Q ultrapure water device (Integral 10, Merck Millipore company, Germany); aqueous needle filter (polyethersulfone, batch number: 9G020320, Shanghai Anpu Scientific Instrument Co., Ltd., China).

[0034] 2. Reagents

[0035] Acetonitrile (Merck Chemical Technology (Shanghai) Co., Ltd., HPLC purity 99.9%, batch number: 1312001YT); trifluoroacetic acid (Beijing Bailingwei Technology Co., Ltd., 99%, batch number: L490O140); heptafluorobutyric acid (Beijing Dima Technology Co., Ltd. Co., Ltd., 99.5%, batch number: 7...

Embodiment 2

[0050] Embodiment 2 methodological verification

[0051] With reference to the four appendices of "Chinese Pharmacopoeia" 2015 edition, methodological research is carried out on the detection method of the present invention. Among them, the compound amino acid (15) dipeptide (2) injection (lot number: 14121601, 14121701, 14121801, from Shuanghe Pharmaceutical) used

[0052] 1. Specificity test

[0053] Take blank solvent (0.1mol / L hydrochloric acid aqueous solution), 5-hydroxytryptophan reference substance solution (concentration is 40.72 μg / ml), L-kynurenine reference substance solution (concentration is 60.80 μg / ml), and supply Test solution, test solution: 5-hydroxytryptophan localization solution (concentration is 400 μg / ml): L-kynurenine localization solution (concentration is 400 μg / ml) is 1:1:1 mixed solution injection Liquid chromatograph, chromatographic condition is the same as embodiment 1, records the chromatogram under 280nm wavelength, finds that other amino ac...

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Abstract

The invention provides a detection method of a relevant substance in a compound amino acid injection. According to the method, 5-hydroxyl tryptophan and L-kynurenine are taken as pointer impurities; separation and baseline stability of various amino acids and the relevant substance contained in the amino acid injection are optimized by a trifluoroacetic acid-heptafluorobutyric acid ion pair chromatographic method; and the detection method is high in detection sensitivity, accuracy and repeatability and can meet requirements on control of the relevant substance in the compound amino acid injection.

Description

technical field [0001] The invention relates to a method for detecting related substances in injections, in particular to a method for detecting related substances in compound amino acid injections. Background technique [0002] Amino acids are the basic units that make up human proteins, and are also the raw materials for the body to synthesize antibodies, hormones, enzymes and other tissues. Compound amino acid injection is generally used for patients with insufficient protein intake, malabsorption and other amino acids that cannot meet the metabolic needs of the body, and is also used to improve the nutritional status of patients after surgery. However, the pharmacopoeias of various countries have not included the detection methods of related substances in compound amino acid injection. Although there are pharmacopoeias that record the detection methods of related substances in amino acid raw materials, these related substances are process impurities remaining in the ami...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/042
Inventor 山广志左利民徐士婕李盼盼宗艳平朱志玲赵婷朱明慧孙伟
Owner MEDICINE & BIOENG INST OF CHINESE ACAD OF MEDICAL SCI
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