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Kit for quantitatively detecting psychotropic drugs in biological sample and application thereof

A biological sample, quantitative detection technology, applied in the field of psychiatric drug detection kits, can solve the problems of prolonged detection time, unfavorable operation of clinical detection personnel, and expensive environment of isotope consumables.

Pending Publication Date: 2022-01-11
SHANGHAI MENTAL HEALTH CENT (SHANGHAI PSYCHOLOGICAL COUNSELLING TRAINING CENT)
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  • Abstract
  • Description
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AI Technical Summary

Problems solved by technology

Therefore, during detection, it is necessary to constantly switch equipment or replace the mobile phase. After the replacement, the instrument must be balanced, which not only prolongs the detection time, but also is not conducive to the operation of clinical testing personnel.
[0004] In addition, the high-performance liquid chromatography ultraviolet detection method often cannot completely realize the chromatographic separation of the drug, which is prone to interference and affects the quantitative results; It is a powerful analysis and detection tool with high separation ability, high sensitivity and high selectivity of mass spectrometer. Although mass spectrometry can be used as a detection method, it can be accurately quantified, but on the one hand, the equipment is expensive, and on the other hand, the isotope internal standard consumables are also very expensive. unfriendly environment

Method used

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  • Kit for quantitatively detecting psychotropic drugs in biological sample and application thereof
  • Kit for quantitatively detecting psychotropic drugs in biological sample and application thereof
  • Kit for quantitatively detecting psychotropic drugs in biological sample and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0074] Embodiment 1: the detection method of complete mixed standard

[0075] A method for simultaneously detecting psychotropic drugs or their metabolites in the body, said method adopts ultra-high performance liquid chromatography-ultraviolet detection method, comprising the following steps:

[0076] S1 chromatographic conditions: (1) Chromatographic column: C 18 Column, ACQUITY UPLC BEH C 18 The diameter is 2.1mm*50mm, and the filler particle size is 1.7μm; (2) mobile phase: phase A is 0.05v / v% formic acid-water solution; phase B is 0.05v / v% formic acid-methanol solution; (3) detector It is an ultraviolet (UV) detector, and the detection wavelength of the ultraviolet detector is full-wavelength scanning; (4) the flow rate of the mobile phase is 0.4mL / min; (5) the column temperature is 40 ° C; (6) the injection volume of the working solution Both are 10.0μL;

[0077] The preparation of S2 working solution includes:

[0078] Preparation of S20 needle washing solution: Mea...

Embodiment 2

[0121] Embodiment 2 takes the detection of the patient serum sample of clozapine, quetiapine fumarate medicine

[0122] S1 chromatographic conditions, S22 The preparation method of mixed standard solution is the same as embodiment 1;

[0123] Preparation of S231 serum test solution: 20 μL each of the internal standard 1-metoclopramide working solution and the internal standard 2-carbamazepine working solution prepared by S21 were precisely drawn, blown dry with nitrogen and mixed with 500 μL thawed frozen serum sample to be tested Mix into a 7mL centrifuge tube, vortex for 1min for the first time, add 200μL of 2mol / L aqueous sodium hydroxide solution, and 3mL of methyl tert-butyl ether, and vortex for 3min for the second time, then put the vortexed Centrifuge the centrifuge tube at a speed of 3000 rpm / centrifuge for 5 minutes, take the centrifuged supernatant and dry it with nitrogen, add 150 μL of methanol-water solution containing 0.1v / v% formic acid and a concentration of 1...

Embodiment 3

[0126] The detection of the serum sample of the patient of embodiment 3 taking amisulpride

[0127] S1 chromatographic conditions, S22 The preparation method of mixed standard solution is the same as embodiment 1;

[0128] S231 need testing solution preparation, S3 measuring method are with embodiment 2:

[0129] The result is as Figure 6 As shown, obtain the retention time of the psychotropic drug and its metabolites (t R ), to get final product; The retention time t of amisulpride R The internal standard 1 metoclopramide was 4.361 min and the peak area Area was 25131; the internal standard 2 carbamazepine was 13.218 min and the peak area Area was 39927. Calculate the peak area ratio of the peak area of ​​amisulpride / internal standard 1 metoclopramide to be y, substitute into the linear equation y=0.0026x+0.0023, C=X*1 / 0.5mL, calculate the blood drug of amisulpride Concentration C was 1103.6 ng / mL.

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Abstract

The invention provides a method for simultaneously and quantitatively detecting psychotropic drugs or metabolites thereof in a biological sample by adopting a UPLC-UV detection method. The method comprises the following steps: S1, chromatographic conditions; S2, working solution preparation; and S3, a determination method. The retention time tR and peak area integral of the standard substance and the test substance of the mental drug and the metabolite thereof are respectively obtained, a standard curve is established for the concentration of the mixed standard substance solution and the corresponding peak area / internal standard area ratio, and then the concentration of the test substance solution is obtained according to the peak area integral of the test substance solution and the standard curve. The invention also discloses a detection kit prepared by the method. According to the present invention, the separation of the common psychiatric drugs in the biological sample is achieved by using the UPLC-UV method, and the kit is prepared from the common psychiatric drugs, such that the in-vivo concentration of the common clinical psychiatric drugs can be rapidly, simply, accurately and quantitatively detected, and the good academic and commercial values are provided.

Description

technical field [0001] The invention relates to the technical field of psychiatric drug detection kits, in particular to a kit for quantitatively detecting psychiatric drugs in biological samples and an application thereof. Background technique [0002] Antipsychotic drugs, also known as strong tranquilizers or neuroleptics, are a group of drugs used to treat schizophrenia and other psychotic disorders. The usual therapeutic dose does not affect the patient's intelligence and consciousness, but it can effectively control the patient's psychomotor excitement, hallucinations, delusions, hostility, thinking disorders and abnormal behaviors and other mental symptoms. Patients usually have sleep disorders and often take sedative and tranquilizer drugs at the same time. Therefore, they need to be separated during detection to obtain stable blood concentration detection values ​​of antipsychotic drugs and avoid interference from other clinical drug combinations. Commonly used clin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/14G01N30/30G01N30/32G01N30/34G01N30/74G01N30/8675G01N2030/324
Inventor 孙秀佳张晨李华芳
Owner SHANGHAI MENTAL HEALTH CENT (SHANGHAI PSYCHOLOGICAL COUNSELLING TRAINING CENT)
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