Kit and detection method for accurately determining blood concentration of multiple antiepileptic drugs in human serum

A technology of antiepileptic drugs and blood drug concentration, which is applied in the field of medical testing, can solve the problems of complex processing operations, long analysis time, and many organic solvents, and achieve the effects of less analysis time, high sensitivity, and less reagent consumption

Inactive Publication Date: 2020-10-16
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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Problems solved by technology

[0005] At present, liquid-phase clinical testing methods are all self-established by the laboratory. There are problems such as complicated pre-treatment operations, long analysis time, many organic solvents required, and low sensitivity. Most of the reagents used are non-kit products. Therefore, there is an urgent need for commercial liquid-phase detection kits

Method used

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  • Kit and detection method for accurately determining blood concentration of multiple antiepileptic drugs in human serum
  • Kit and detection method for accurately determining blood concentration of multiple antiepileptic drugs in human serum
  • Kit and detection method for accurately determining blood concentration of multiple antiepileptic drugs in human serum

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] 1. Calibration product mother solution: use methanol as the diluent to prepare a calibration product mother solution including 6 concentration points, and the 6 concentration points of the calibration product mother solution are as follows:

[0071] Lamotrigine: 10.00μg / mL, 20.00μg / mL, 50.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL;

[0072] Phenobarbital: 20.00μg / mL, 40.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL, 800.00μg / mL;

[0073] Oxcarbazepine: 15.00μg / mL, 30.00μg / mL, 75.00μg / mL, 150.00μg / mL, 300.00μg / mL, 600.00μg / mL;

[0074] Carbamazepine: 15.00μg / mL, 30.00μg / mL, 75.00μg / mL, 150.00μg / mL, 300.00μg / mL, 600.00μg / mL;

[0075] Phenytoin: 20.00μg / mL, 40.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL, 800.00μg / mL;

[0076] The mother liquor of the above-mentioned calibrator is a mixed solution of lamotrigine, phenobarbital, oxcarbazepine, carbamazepine and phenytoin; the concentration of the six points is the concentration of each component in the total mixed ...

Embodiment 2

[0105] 1. Calibration product mother solution: use methanol as the diluent to prepare a calibration product mother solution including 6 concentration points, and the 6 concentration points of the calibration product mother solution are as follows:

[0106] Lamotrigine: 10.00μg / mL, 20.00μg / mL, 50.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL;

[0107] Phenobarbital: 20.00μg / mL, 40.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL, 800.00μg / mL;

[0108] Oxcarbazepine: 15.00μg / mL, 30.00μg / mL, 75.00μg / mL, 150.00μg / mL, 300.00μg / mL, 600.00μg / mL;

[0109] Carbamazepine: 15.00μg / mL, 30.00μg / mL, 75.00μg / mL, 150.00μg / mL, 300.00μg / mL, 600.00μg / mL;

[0110] Phenytoin: 20.00μg / mL, 40.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL, 800.00μg / mL;

[0111] The mother solution of the above-mentioned calibrator is a mixed solution of lamotrigine, phenobarbital, oxcarbazepine, carbamazepine and phenytoin; the concentration of the six points is the concentration of each component in the total mixe...

Embodiment 3

[0123] 1. Calibration product mother solution: use methanol as the diluent to prepare a calibration product mother solution including 6 concentration points, and the 6 concentration points of the calibration product mother solution are as follows:

[0124] Lamotrigine: 10.00μg / mL, 20.00μg / mL, 50.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL;

[0125] Phenobarbital: 20.00μg / mL, 40.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL, 800.00μg / mL;

[0126] Oxcarbazepine: 15.00μg / mL, 30.00μg / mL, 75.00μg / mL, 150.00μg / mL, 300.00μg / mL, 600.00μg / mL;

[0127] Carbamazepine: 15.00μg / mL, 30.00μg / mL, 75.00μg / mL, 150.00μg / mL, 300.00μg / mL, 600.00μg / mL;

[0128] Phenytoin: 20.00μg / mL, 40.00μg / mL, 100.00μg / mL, 200.00μg / mL, 400.00μg / mL, 800.00μg / mL;

[0129] The mother solution of the above-mentioned calibrator is a mixed solution of lamotrigine, phenobarbital, oxcarbazepine, carbamazepine and phenytoin; the concentration of the six points is the concentration of each component in the total mixe...

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Abstract

The invention discloses a kit and a detection method for accurately determining the blood concentration of multiple antiepileptic drugs in human serum. The kit mainly comprises a calibration product mother liquor, methanol or acetonitrile is used as a diluent to prepare the calibration product mother liquor comprising six concentration points, the calibration product mother liquor includes lamotrigine, phenobarbital, oxcarbazepine, carbamazepine and phenytoin in order; the kit also comprises an internal standard, a quality control material, a matrix correction solution and an extract, whereinthe extract is a tert-butyl methyl ether solution, a reconstitution solution and a mobile phase. Complex purification steps are not needed, and the required analysis time is short; and the detection speed is increased.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to a kit and a detection method for accurately measuring blood concentrations of various antiepileptic drugs in human serum. Background technique [0002] Phenobarbital (PB), phenytoin (PHT), carbamazepine (CBZ), oxcarbazepine (OXC) and lamotrigine (LTG) They are all control drugs. The vast majority of epilepsy patients need long-term medication and have great individual differences in drug response. PB, PHT, and CBZ are the first-line antiepileptic drugs commonly used in clinical practice, while OXC and LTG are the second-generation antiepileptic drugs that have been on the market in the past decade. Due to the different pharmacological characteristics and clinical indications of each drug, they are often used in combination in clinical practice. [0003] However, its therapeutic concentration range is very narrow, the individual differences in metabolism are large, the po...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/14G01N30/86G01N30/34
CPCG01N30/06G01N30/14G01N30/8665G01N30/8679G01N30/34G01N2030/045G01N2030/062
Inventor 邹继华沈敏潘清清杨晓东屠敏敏邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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