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Method for determining concentration of tegafur, gimeracil and 5-fluorouracil in plasma of tumor patient

A technology of gimeracil and fluorouracil, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of low signal-to-noise ratio, long chromatographic running time, and insufficient sensitivity of 5-fluorouracil to fully describe the pharmacokinetic characteristics, etc., to achieve sensitive High, fast detection speed, good selectivity

Active Publication Date: 2021-05-25
苏州海科医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In 2010, Ke Liu et al. developed a liquid chromatography-tandem mass spectrometry method for the simultaneous determination of tegafur, gimeracil and 5-fluorouracil. The sensitivity of the method to determine 5-fluorouracil is not enough to fully characterize its pharmacokinetics
In addition, the chromatographic running time of this method is as long as 7.5min, which is not conducive to the determination of large quantities of clinical research samples.
Secondly, the quantitative lower limit signal-to-noise ratio of each component to be determined in this method is low. Tegafur, gimeracil and 5-fluorouracil are about 3, 2 and 5, respectively, and there are obvious interference peaks. big deviation

Method used

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  • Method for determining concentration of tegafur, gimeracil and 5-fluorouracil in plasma of tumor patient
  • Method for determining concentration of tegafur, gimeracil and 5-fluorouracil in plasma of tumor patient
  • Method for determining concentration of tegafur, gimeracil and 5-fluorouracil in plasma of tumor patient

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Embodiment

[0037] pre-processing

[0038] The amount of plasma used in the present invention is only 50.0 μL, and the extraction method in the present invention is the protein precipitation method, which has a high recovery rate for polar substances, and has the advantages of simple operation, short extraction time, high-quality and high-quality suitable for clinical research. Quantitative sample pretreatment.

[0039] like Figure 1 to Figure 6 , the specific preprocessing steps are as follows:

[0040] 1. Add 50.0 μL plasma sample to the 96-well plate;

[0041] 2. Add 25.0 μL internal standard solution (FT- 13 C, 15 N 2 , CDHP- 13 C 3 , 5-FU- 13 C, 15 N 2 The concentration is 1500 / 300 / 150ng / mL respectively);

[0042] 3. Add 200 μL of acetonitrile; vortex for 10 minutes, centrifuge (4°C) for 10 minutes (4500 rpm);

[0043] 4. Take 100 μL of the supernatant and dry it in a nitrogen stream to concentrate;

[0044] 5. The residue was dissolved in 120 μL of reconstitution solvent...

Embodiment 1

[0054] Abbreviation

[0055]

[0056] 1 material

[0057] 1.1 Instrument

[0058] Chromatograph: LC-30AD fast liquid chromatography system, Shimadzu Corporation, Japan.

[0059] Mass spectrometer: 6500 + A type triple quadrupole tandem mass spectrometer equipped with an electrospray ionization source (Turbo Ion Spray) from Sciex, Canada.

[0060] Software used for data processing: Analyst (version 1.6.3), Sciex, Canada.

[0061] Centrifuge: HerμLe Z2326K desktop centrifuge, Germany Hermer Company.

[0062] Analytical balance: CPA225D analytical balance, Beijing Sartorius Instrument Co., Ltd.

[0063] 1.2 Reference substances and reagents

[0064] Tegafur (content 99.71%), gimeracil (purity 99.55%), and 5-fluorouracil (purity 99.85%) were purchased from Dalian Meilun Biotechnology Co., Ltd. 13 C 15 N 2 - Tegafur, 13 C 3 - Gimeracil, 13 C 15 N 2 - Fluorouracil was purchased from TRC. Methanol (HPLC grade) and acetonitrile (HPLC grade) were purchased from Sigma,...

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Abstract

The invention relates to a method for determining the concentration of tegafur, gimeracil and 5-fluorouracil in plasma of a tumor patient. The tegafur, gimeracil and 5-fluorouracil in the plasma are analyzed through LC-MS / MS, a protein precipitation pretreatment method is adopted, a corresponding isotope label is used as an internal standard, an EclipseXDB-C18 column is adopted, gradient elution is carried out, and electrospray ionization (ESI) source tandem mass spectrometry detection is carried out. The method is high in specificity and selectivity, high in sensitivity and rapid in detection, and meets the requirement for large-batch sample analysis in clinical research.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a method for measuring the concentrations of tegafur, gimeracil and 5-fluorouracil in plasma of tumor patients. Background technique [0002] Developed by Taiho, Japan, S-1 capsule was first launched in Japan in 1999 and is clinically used to treat gastric cancer, head and neck cancer, colorectal cancer, non-small cell lung cancer, breast cancer and pancreatic cancer. S-1 capsule is the first-line drug for the treatment of advanced gastrointestinal malignancies. S-1 Capsules are composed of three main pharmaceutical ingredients: tegafur, gimeracil and oteracil potassium. Among them, tegafur is converted into the active product 5-fluorouracil in the body to exert its medicinal effect. In order to promote the research and development of generic drugs of S-1 Capsules, it is necessary to monitor the concentration levels of various drug ingredients in the blood to ob...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8822
Inventor 陈涛杨勇钟勘陈鑫周林芳潘婷李航温凤娇占远姜金方周茂金
Owner 苏州海科医药技术有限公司
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