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Analytical method for pharmacokinetics of multicomponent traditional Chinese medicine

An analysis method and multi-component technology, applied in the direction of analysis of materials, scientific instruments, material separation, etc., can solve the problems of complex components of traditional Chinese medicine, difficulty in purchasing, and inability to reveal the law of metabolic kinetics, etc., to reduce test costs, test The results are accurate and reliable, and the effect of shortening the test cycle

Inactive Publication Date: 2011-09-07
JILIN UNIV
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Problems solved by technology

Due to the large number of chemical components in traditional Chinese medicine, it is difficult to purchase all standard products
The pharmacokinetic evaluation of traditional Chinese medicine is currently based on the chemical drug research method to determine one or several of the various components, which obviously cannot reveal the pharmacokinetic laws of multi-component traditional Chinese medicine
Due to the complex composition of traditional Chinese medicine, even a single traditional Chinese medicine contains dozens of types and hundreds of chemical components. Therefore, it is not appropriate to use the pharmacokinetic research results of a few components to represent the pharmacokinetic characteristics of a certain traditional Chinese medicine or a certain compound drug. precise

Method used

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  • Analytical method for pharmacokinetics of multicomponent traditional Chinese medicine
  • Analytical method for pharmacokinetics of multicomponent traditional Chinese medicine
  • Analytical method for pharmacokinetics of multicomponent traditional Chinese medicine

Examples

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Embodiment 1

[0029] Example 1 Pharmacokinetic study of Cimicifuga saponins

[0030] 1. Preparation of drug solution

[0031] Cimicifuga raw material is the "standard product", and standard series solutions are prepared: accurately weigh 10.0 mg of Cimicifuga raw material, dilute to 10 mL with methanol, and use methanol-water (80:20, v / v) solution to gradually Diluted to 0.5, 2.0, 10, 50, 200, 800μg / mL, as a standard series solution.

[0032] 2. Establishment of LC-MS / MS multi-component determination method for Cimicifuga saponins

[0033] Taking Cimicifuga raw material as the standard substance of the substance group, dilute it to an appropriate multiple with methanol-water (80:20, v / v):

[0034] (1) Injecting samples with a syringe pump (FIA), the Q1 of the mass spectrometry adopts a full-scan mode to obtain the m / z data of the Cimicifuga subgroup with higher response;

[0035] (2) These data are respectively used as the ions monitored by the SIM of LC-MS / MS, and input into the mass sp...

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Abstract

The invention provides an analytical method for pharmacokinetics of a multicomponent traditional Chinese medicine, and belongs to the technical field of medicine component analysis. Quantitative reactive ions of various components in bulk pharmaceutical chemicals are built in a multiple reaction monitor scanning manner of liquid chromatogram-tandem mass spectrometry and taking the bulk pharmaceutical chemicals as 'standard substances', and the concentrations of various traditional Chinese medicine components in a biological sample are relatively quantified. The method comprises the following specific steps: preparing a bulk pharmaceutical chemical solution; building a liquid chromatogram-mass spectrometry analysis condition; testing in vivo; measuring the biological sample; and processing the data. The method provided by the invention ensures that the quantitative analysis on multicomponent traditional Chinese medicine in the biological sample is realized without the standard substance. By utilizing the method, the pharmacokinetic analysis is performed on the known or unknown components in a traditional Chinese preparation. The result shows that the precision and accuracy obtained by the method conform to the requirements of relevant specifications of SFDA (the State Food and Drug Administration).

Description

Technical field: [0001] The invention belongs to the technical field of drug component analysis, in particular to an analysis method for evaluating multi-component pharmacokinetics of traditional Chinese medicines. More specifically, it is a liquid chromatography-mass spectrometry LC / MS / MS analysis method for determining the content of various components of traditional Chinese medicine in biological samples. Background technique: [0002] Pharmacokinetics is a discipline that quantitatively studies the absorption, distribution, metabolism and excretion of drugs in organisms: based on the measured drug concentrations in biological samples, mathematical principles and methods are used to explain the changes in blood drug concentrations over time. [0003] Traditional Chinese medicine compound has the characteristics of multi-taste, multi-component, and multi-dosage forms, and there are multi-factor interactions in complex environments and disease model conditions. Due to the ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/72
Inventor 顾景凯盖芸芸刘万卉杨艳张超张继稳李海燕
Owner JILIN UNIV
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