Method for determining concentration of tandospirone in human plasma

A technology of tandospirone 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 measurement cannot be realized, and achieves high accuracy, easy operation, and stable baseline.

Active Publication Date: 2021-06-18
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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 determining concentration of tandospirone in human plasma
  • Method for determining concentration of tandospirone in human plasma
  • Method for determining concentration of tandospirone 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 medicine detection, and discloses a method for determining the concentration of tandospirone in human plasma, which comprises the following steps: detecting tandospirone in a pretreated human plasma sample by adopting a high performance liquid chromatography-mass spectrometry technology, separating tandospirone from impurities by utilizing high performance liquid chromatography, quantifying by utilizing an isotope internal standard method, establishing a standard curve regression equation by taking the concentration ratio of the standard substance in the standard solution to the internal standard substance in the internal standard working solution as an X axis and the peak area ratio of the standard substance in the standard solution to the internal standard substance in the internal standard working solution as a Y axis, and performing linear least square regression calculation on the theoretical concentration ratio of the standard substance to the internal standard substance in the standard curve regression equation according to the peak area ratio of the substance to be detected to the internal standard substance, and calculating the actually measured concentration of tandospirone in the human plasma sample according to the obtained standard curve regression equation. According to the invention, the defect of accurate quantitative detection at a relatively low concentration level is overcome, and the requirement of measuring the content in a living body when the dosage is relatively small can be met.

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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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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