Method for Determination of Tandospirone Concentration in Human Plasma

A technology for tandospirenone and human plasma, which is applied in the field of medical testing, can solve the problems that the lower limit of detection cannot meet the content determination, low-precision quantitative detection, and the determination cannot be realized, etc., and achieves the effects of high accuracy, simple operation and stable baseline.

Active Publication Date: 2021-08-13
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

[0003] At present, high-performance liquid chromatography is the main method, and the detection limit cannot meet the content determination in the organism when the dosage is small.
CN200810135089.7 discloses a method of detecting different configurations of tandospirone citrate by using high performance liquid chromatography to control the quality of the preparation, but it is impossible to measure the small dosage in vivo; literature (Huang Hongyong, Medicine The Herald, June 2013, Volume 32, Issue 6, 707-710) disclosed the human bioequivalence experiment of two tandospirone citrate preparations, using high performance liquid chromatography to test the tandospirone citrate in human plasma. The content of spirone was detected, and its linearity was good in the range of 10~1000μg / L, and the lowest detection limit was 10μg / L, which could not achieve a lower level of accurate quantitative detection, and there were limitations in the actual application process

Method used

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  • Method for Determination of Tandospirone Concentration in Human Plasma
  • Method for Determination of Tandospirone Concentration in Human Plasma
  • Method for Determination of Tandospirone Concentration in Human Plasma

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Embodiment 1

[0092] 1. Solution preparation

[0093] Mobile phase A (5mM ammonium acetate aqueous solution): Weigh 770.8mg of ammonium acetate and dissolve it in 2L of ultrapure water, ultrasonically degas, and mix well.

[0094] Mobile phase B (acetonitrile): Measure 2L of acetonitrile into a brown solvent bottle.

[0095] Diluted solution (50% acetonitrile in water): transfer 100mL of acetonitrile and 100mL of ultrapure water to an appropriate solvent bottle, and mix well.

[0096] Preparation of needle washing solution (50% methanol aqueous solution): Measure 500mL of methanol and 500mL of ultrapure water, transfer them to an appropriate solvent bottle, and mix well.

[0097] 2. Standard solution preparation:

[0098] Preparation of standard reference substance stock solution

[0099] Weigh a certain amount of tandospirone reference substance, record the weight, put it in a self-made cup-shaped aluminum foil paper, put the aluminum foil paper in a 20mL brown wide-mouth glass bottle, ...

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Abstract

The invention belongs to the technical field of medical detection, and discloses a method for measuring the concentration of tandospirone in human plasma, using high performance liquid phase tandem mass spectrometry technology to detect tandospirone in pretreated human plasma samples, and using high performance liquid chromatography to detect tandospirone Tandospirone is separated from impurities, and then quantified by the isotope internal standard method. The concentration ratio of the standard in the standard solution and the internal standard in the internal standard working solution is the X axis, and the internal standard in the standard solution and the internal standard in the working solution are The peak area ratio of the standard substance is the Y axis, and the standard curve regression equation is established, and the linear least squares method is used to calculate the theoretical concentration ratio of the standard substance and the internal standard substance in the standard curve regression equation based on the peak area ratio of the analyte and the internal standard substance. , the measured concentration of tandospirone in human plasma samples was calculated by the obtained standard curve regression equation. The invention overcomes the defect of precise quantitative detection at a lower concentration level, and can meet the content determination requirement in a living body when a small dosage is administered.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a method for measuring the concentration of tandospirone in human plasma. Background technique [0002] Tandospirone, the main action site is concentrated in the hippocampus, amygdala and other brain limbic systems in the emotional center and the raphe nucleus that projects 5-HT nerves. By stimulating 5-HT1A autoreceptors, it regulates the 5-HTergic nerve projected from the raphe to the hippocampus, inhibits the 5-HT effect of the behavioral inhibition system, and exerts an anxiolytic effect. Since the binding site of tandospirone is relatively concentrated, it can exert a more selective anxiolytic effect. It has a good therapeutic effect on nervous disorders, essential hypertension, peptic ulcer, insomnia and other symptoms such as restlessness and mental depression. In particular, high blood pressure, peptic ulcer, insomnia, etc. are often only treated symptomatical...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675
Inventor 廖志正张洁
Owner HUNAN HUIZE BIO PHARMA CO LTD
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