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Analysis method for evaluating pharmacokinetic matrix effect of Chinese patent medicine

A technology of matrix effect and analysis method, which is applied in the analysis field of evaluating the pharmacokinetic matrix effect of Chinese patent medicine, and can solve the problems that no one has proposed to systematically investigate the matrix effect of Chinese medicine pharmacokinetics

Inactive Publication Date: 2020-02-28
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

So far, no one has proposed a method to systematically investigate the pharmacokinetic matrix effect of traditional Chinese medicine.

Method used

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  • Analysis method for evaluating pharmacokinetic matrix effect of Chinese patent medicine
  • Analysis method for evaluating pharmacokinetic matrix effect of Chinese patent medicine
  • Analysis method for evaluating pharmacokinetic matrix effect of Chinese patent medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099]SD rats were selected as experimental animals, and SD rats were SPF grade, male, weighing 230-270 g.

[0100] Xuebijing is selected as the Chinese patent medicine, which is composed of safflower, red peony root, salvia miltiorrhiza, Chuanxiong and angelica. A large number of clinical and basic studies have proved that Xuebijing is an effective Chinese patent medicine for the treatment of sepsis, and its curative effect mainly depends on the key components that can be effectively used by the body. Safflower is a monarch drug, and its main active ingredients are flavonoids. The content of hydroxy A in flavonoids (0.2–0.5mg / mL) is much higher than other flavonoids, and it is one of the quality control components of Xuebijing. Previous pharmacokinetic studies on Xuebijing showed that after administration of Xuebijing, hydroxy A was significantly exposed in vivo compared with other Xuebijing substances and was mainly eliminated from the body through urinary excretion in the ...

Embodiment 2

[0124] Prepare the standard solution whose concentration range of hydroxysafflower yellow A is 15.6-8000nmol / L, carry out LC / MS / MS detection, take the chromatographic peak area as the ordinate (Y axis), the quality of its corresponding hydroxysafflower yellow A The concentration is the abscissa (X-axis), and the regression analysis is carried out to obtain the regression equation and its correlation coefficient, as shown in Table 1. It can be seen from Table 1 that the linear relationship of the above regression equation is good when the sample is injected within the corresponding concentration range, and the correlation coefficient r>0.99.

[0125] Table 1

[0126]

Embodiment 3

[0128] According to Example 1, the plasma sample a of Xuebijing 10 mL / kg was administered to rats via tail vein injection, and the plasma concentration data of hydroxy A in the body are shown in Table 2. Table 3 shows the plasma concentration of hydroxy A in rats after tail vein injection of 4.2 mg / kg hydroxy A solution in plasma sample b.

[0129] With the blood drug concentration data of hydroxy A in the rat body in table 2 and table 3, draw the hydroxy A mean blood drug concentration-time curve, obtain figure 1 , figure 2 ,in, figure 1 It is the average blood drug concentration-time curve of hydroxy A in rats after administration of Xuebijing; figure 2 It is the average plasma concentration-time curve of hydroxy A in rats after administration of hydroxy A solution.

[0130] The blood concentration data of hydroxy A in rats in Table 2 and Table 3 were calculated using the pharmacokinetic software Kinetica5.0 to obtain plasma pharmacokinetic parameter data Tables 4 and 5...

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PUM

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Abstract

The invention provides an analysis method for evaluating the pharmacokinetic matrix effect of a Chinese patent medicine, and the method comprises the following steps: 1) respectively administrating the Chinese patent medicine and key components in the Chinese patent medicine to laboratory mice, and collecting body fluid; 2) analyzing the body fluid, and determining the concentration of key components in the Chinese patent medicine contained in the body fluid; 3) performing the calculating by adopting a trapezoidal method to obtain AUC0-t; 4) calculating AUC0-infinity; 5) calculating the totalplasma clearance rate; 6) calculating a kidney clearance rate and a bile clearance rate; 7) calculating a steady-state distribution volume; 8) calculating a urine accumulated excretion score and a bile accumulated excretion score; 9) carrying out sample T inspection on the pharmacokinetic parameters to evaluate the significant difference, and determining the pharmacokinetic matrix effect of the key components in the Chinese patent medicine. According to the analysis method for evaluating the pharmacokinetic matrix effect of the Chinese patent medicine, the pharmacokinetic matrix effect of thekey components of the Chinese patent medicine can be quickly and accurately evaluated, and the analysis method has important significance in revealing the compatibility rule of the key component prescription in the Chinese patent medicine based on pharmacokinetics.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine pharmacokinetics, and relates to an analysis method for evaluating the pharmacokinetic matrix effect of Chinese patent medicines. Background technique [0002] Chinese patent medicines are made of traditional Chinese medicinal materials. Under the guidance of the theory of traditional Chinese medicine, in order to prevent and treat diseases, according to the prescribed prescription and preparation process, they are processed into certain dosage forms of traditional Chinese medicine products, which are approved by the State Drug Administration Department. A class of commercialized traditional Chinese medicine preparations. Common dosage forms of Chinese patent medicines include tablets, pills, powders, ointments, injections, etc. Compared with chemical medicines, the chemical composition of Chinese patent medicines is complex, and the process of changes in the body after administration ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/72
CPCG01N30/02G01N30/06G01N30/34G01N30/72
Inventor 李川程晨余玄杜飞飞徐方王凤清董凯张桂萍姚小青
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI