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Pharmacokinetic analysis method for monitoring therapeutic drugs

A technology of pharmacokinetics and therapeutic drugs, which is applied in the directions of drug reference, informatics, computational theoretical chemistry, etc., can solve problems such as monitoring of genetic polymorphism information in patients, reduce the risk of adverse reactions, improve curative effect, well-designed effects

Pending Publication Date: 2022-03-08
SUZHOU LEO BIOTECH
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Problems solved by technology

[0004] The Chinese patent application number is CN201510132249.2, which discloses a curve simulation and prediction method of pharmacokinetics of traditional Chinese medicine. The purpose is to obtain the blood drug concentration-time curve of one or a few compounds in the body for the compound preparation of traditional Chinese medicine. In order to predict the blood drug concentration-time curve of other compounds in the body, obtain relevant pharmacokinetic parameters, and provide new ideas for the pharmacokinetics of traditional Chinese medicine compounds, without monitoring based on patient genetic polymorphism information

Method used

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Embodiment

[0020] A pharmacokinetic analysis method for therapeutic drug monitoring, comprising the steps of:

[0021] (1) Establish a blood drug concentration measurement method: use UPLC-MS / MS to establish a blood drug concentration measurement method that can simultaneously monitor the therapeutic drug and its main metabolites in the patient's plasma sample, and perform a test on the established blood drug concentration measurement method Methodology verification, verification content includes stability, matrix effect and recovery rate, linear density and accuracy, linearity and lower limit of quantification, specificity, when stability, matrix effect and recovery rate, linear density and accuracy, linearity and lower limit of quantitation All 6 items of specificity and specificity are met, which means that the established blood drug concentration determination method has been verified;

[0022] (2) Establish a pharmacokinetic model: use GastroPlusTM software, based on the physical an...

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Abstract

A pharmacokinetic analysis method for monitoring therapeutic drugs comprises the following steps: (1) establishing a plasma concentration determination method: establishing the plasma concentration determination method capable of simultaneously monitoring the therapeutic drugs and main metabolites thereof in a plasma sample of a patient by adopting UPLC-MS / MS, and performing methodological verification on the established plasma concentration determination method; (2) establishing a pharmacokinetic model; and (3) monitoring treatment drugs. The pharmacokinetic analysis method for monitoring the therapeutic drug is reasonable in design, provides a basis for individualization of clinical medication of the therapeutic drug by taking the therapeutic drug as a monitoring target, taking blood concentration monitoring as a core and combining pharmacokinetic research data, and provides a basis for clinical medication individualization of the therapeutic drug by monitoring the therapeutic drug for a patient. The curative effect of the treatment medicine can be obviously improved, the occurrence risk of adverse reaction of the treatment medicine is reduced, and the application prospect is wide.

Description

technical field [0001] The invention belongs to the technical field of pharmacokinetics, and in particular relates to a pharmacokinetic analysis method for therapeutic drug monitoring. Background technique [0002] Pharmacokinetics is a subject that quantitatively studies the absorption, distribution, metabolism and excretion of drugs in organisms, and uses mathematical principles and methods to explain the changes in blood concentration over time. With the development of medicinal chemistry and the continuous improvement of human health, the requirements for the pharmacokinetic properties of drugs are getting higher and higher: judging the application prospects of a drug, especially the market prospect, is not only strong in curative effect, but less toxic and side effects; It should also have good pharmacokinetic properties. [0003] With the development of precision medicine, clinical departments of various hospitals, in addition to adjusting the dose and type of drugs f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H70/40G16C10/00
CPCG16H70/40G16C10/00
Inventor 张卫军
Owner SUZHOU LEO BIOTECH
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