Liquid chromatogram analysis method for detecting drug content of phenytoin sodium in blood

A liquid chromatographic analysis and phenytoin sodium technology is applied in the field of detecting the drug concentration of phenytoin sodium in blood, which can solve the problems of poor quantitative reproducibility, narrow safety range, toxic and side effects of external standard method, and achieves simple and rapid detection process and experimental cost. The effect of reducing and eliminating systematic errors

Inactive Publication Date: 2018-05-15
BEIJING HARMONY HEALTH MEDICAL DIAGNOSTICS CO LTD
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Problems solved by technology

Phenytoin, as the drug of choice for adults with epilepsy, has a low therapeutic index, narrow safety range, and large individual differences. If the dosage and usage are not appropriate in clinical practice, it may lead to poor curative effect or serious side effects. Therefore, the blood concentration of phenytoin should be monitored and individual medication is necessary
[0003] The detection methods that have been reported to determine the plasma concentration of phenytoin sodium mainly include fluorescence polarization immunoassay, enzyme-linked immunosorbent assay, ultraviolet spectrophotometry, liquid chromatography-mass spectrometry, high-performance liquid chromatography, etc. Among them, the imported Reagents are expensive, and the specificity of the kit used is slightly poor; the pretreatment operation of ultraviolet spectrophotometry is complicated, time-consuming and labor-intensive, and it is difficult to analyze a large number of samples; the analysis cost of liquid chromatography-mass spectrometry is relatively high, requiring personnel and space High performance liquid chromatography is not suitable for widespread use in small and medium-sized hospitals; high performance liquid chromatography has the advantages of accuracy, sensitivity, strong specificity, good reproducibility, and low cost, and has become the main method for determining the blood concentration of phenytoin sodium
However, the pretreatment of the HPLC method currently used is relatively complicated, and the quantitative reproducibility of the external standard method is poor. In addition, there are problems such as a long analysis time and a large consumption of organic solvents.

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  • Liquid chromatogram analysis method for detecting drug content of phenytoin sodium in blood

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Embodiment Construction

[0037] The present invention detects the liquid chromatographic analysis method of phenytoin sodium drug content in blood, comprises the steps:

[0038] (1) Calibration of standard solution

[0039] Firstly, 10 μL of standard working solutions of seven different concentrations were mixed with 10 μL of internal standard working solution and 80 ul of methanol to make seven standard solutions. The above standard solutions were vortexed and mixed for 1 min at a speed of 1500 rpm, and then analyzed by liquid chromatography. Instrument and ultraviolet detector detect above-mentioned standard solution, draw the phenytoin sodium of above-mentioned seven kinds of standard solutions and internal standard chromatogram, as figure 2It is one of them. The peak area of ​​the standard target and the peak area of ​​the internal standard are respectively obtained in the chromatograms of the above-mentioned phenytoin sodium and the internal standard, and the ratio of the peak area of ​​the abov...

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Abstract

The invention discloses a liquid chromatogram analysis method for detecting the drug content of phenytoin sodium in blood. The liquid chromatogram analysis method comprises the following steps: usinga liquid chromatogram analysis instrument and an ultraviolet detector to calibrate a standard solution, fitting to obtain a standard curve equation that y equals to the sum of a*x and b, taking a blood sample to be detected, after the blood to be detected is treated, using the liquid chromatogram analysis instrument and the ultraviolet detector to detect the sample to be detected as well to obtainy value of the blood to be detected, substituting the y of the blood to be detected into the standard curve equation, and carrying out calculation to obtain the relative concentration x of a target objective in the blood sample to be detected, wherein the concentration of the working solution of an internal standard substance is known, and the drug concentration of phenytoin sodium in the blood to be detected is calculated and obtained. According to the method, the accuracy of a quantitative result is improved, the analysis time is greatly shortened, the detection process is simple and quick,the blood concentration of phenytoin sodium inside the body of a patient during clinic treatment can be monitored better, and experimental foundation is provided for individual dosing of antiepileptic drug phenytoin sodium and the occurrence of reducing toxic and / or side effects.

Description

technical field [0001] The invention relates to the technical field of clinical blood drug concentration monitoring of psychotropic drugs, in particular to a method for detecting the drug concentration of phenytoin sodium in blood. Background technique [0002] Phenytoin Sodium (Phenytoin Sodium) is one of the effective antiepileptic drugs commonly used in the first line of clinical practice. It is suitable for the treatment of epileptic generalized tonic-clonic seizures, simple and complex partial seizures, secondary generalized seizures and status epilepticus. The molecular formula is C 15 h 11 N 2 NaO 2 , the specific structural formula is as figure 1 shown. Phenytoin, as the drug of choice for adults with epilepsy, has a low therapeutic index, narrow safety range, and large individual differences. If the dosage and usage are not appropriate in clinical practice, it may lead to poor curative effect or serious side effects. Therefore, the blood concentration of phenyto...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 张国成许丽贾永娟倪君君
Owner BEIJING HARMONY HEALTH MEDICAL DIAGNOSTICS CO LTD
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