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Method for building population pharmacokinetics model of multiple components of compound salvia miltiorrhiza drop pills in rats

A technology of pharmacokinetics and construction methods, applied in the field of construction of multi-component compound pharmacokinetic models of compound Danshen dripping pills in vivo in rats

Active Publication Date: 2020-11-24
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently there is no consensus on the validation method most suitable for a population pharmacokinetic model, and often the choice of validation method depends on the goals of the analysis

Method used

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  • Method for building population pharmacokinetics model of multiple components of compound salvia miltiorrhiza drop pills in rats
  • Method for building population pharmacokinetics model of multiple components of compound salvia miltiorrhiza drop pills in rats
  • Method for building population pharmacokinetics model of multiple components of compound salvia miltiorrhiza drop pills in rats

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Example 1: Method for constructing the population pharmacokinetic model of compound Danshen dripping pills multi-components in rats

[0118] 1. Proposed sampling point time: Proposed sampling point time: Considering the long half-life of ginsenoside Rb1, the designed sampling points are: 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h. Divide the sampling points into 4 groups, (Group A: 5min, 1.5h, 6h) (Group B: 15min, 2h, 8h, 24h) (Group C: 30min, 3h, 10h, 48h) (Group D: 1h, 4h, 12h, 72h).

[0119] 2. Determine the influencing factors to be investigated (influencing factors are referred to as covariates hereinafter): the physiological and pathological information of the rats are used as the covariates to be investigated, and the influence of these factors on drug metabolism is investigated, and finally the sex, age, and body weight of the rats are determined. as a covariate to be investigated.

[0120] 3. A certain number of test samples we...

Embodiment 2

[0168] Example 2. Analytical method of danshensu, ginsenoside Rb1, Rg1 in rat plasma

[0169] 1. Chromatography and mass spectrometry conditions Liquid phase method: Shimadzu UFLC liquid phase system, using ACQUITY from Waters HSS T3column (1.8μm, 2.1mm×100mm) chromatographic column, equipped with pre-column VanGuard TM HSS T3pre-column (1.8μm, 2.1mm×5mm), flow rate 0.4mL / min, column temperature 40°C, mobile phase: A: 0.1% formic acid-water, B: acetonitrile. Gradient elution is used, taking the change of phase B as a reference, and the elution program is: 0→0.8min, 5%; 0.8→3.1min, 5%→90%; 3.1→3.3min, 90%→5%, 3.3→4.5 min, 5%.

[0170] Mass spectrometry conditions: Mass spectrometry detection is carried out synchronously according to the positive and negative ion modes.

[0171] Positive ion mode: curtain gas pressure (Curtain gas, abbreviated as GUR): 20psi, ion source voltage: 5500V, ion source temperature: 550°C, ion source gas 1: 55psi, ion source gas 2: 55psi; internal...

Embodiment 3

[0181] Embodiment 3: rat experiment

[0182] 1. Dosing and sampling plan

[0183] Compound Danshen dripping pills were given by intragastric administration, and the administration time was arranged at 8:00-9:00 am on the day of the experiment. The dosage of compound Danshen dripping pills was 1.5g / kg. The dissolution rate is 0.3g / mL, the administration volume is 1mL / 200g, and the specific drug volume is adjusted according to the body weight of the rat. Rats were fasted for 12 hours before administration, had free access to water, and ate uniformly 3 hours after administration.

[0184] Considering the long half-life of ginsenoside Rb1, the design sampling points are: 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h. Divide the sampling points into 4 groups, (Group A: 5min, 1.5h, 6h) (Group B: 15min, 2h, 8h, 24h) (Group C: 30min, 3h, 10h, 48h) (Group D: 1h, 4h, 12h, 72h), and then randomly divide rats of different sexes and ages into each group, coll...

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Abstract

The invention relates to a method for building a population pharmacokinetics model of multiple components of compound salvia miltiorrhiza drop pills in rats. The method comprises the following steps of: (1) determining sampling point time: grouping sampling points at random on the basis of holographic sampling, with 3-4 sampling points in each group; (2) determining to-be-investigated covariates (the covariates are influence factors): taking physiological and pathological information of rats as the to-be-investigated covariates and investigating the influences of these factors on drug metabolism; (3) incorporating a certain number of tested samples: incorporating the tested samples for the covariates, and confirming that the incorporated samples are uniformly distributed for the covariatesand the test range is relatively wide and meets the later prediction range; (4) carrying out administration, sample acquisition, information collection and sample determination: determining an administration scheme of a compound salvia miltiorrhiza drop pill solution, acquiring blood samples within a predetermined sampling time range, recording corresponding acquisition time, recording individualrelated information for the predetermined covariates and completing sample determination work by using a detection method; and (5) building a model.

Description

technical field [0001] The invention belongs to the field of pharmacokinetics, and in particular relates to a method for constructing a group pharmacokinetic model of compound Danshen dripping pills in rats. Background technique [0002] Compound Danshen Dripping Pill is a medicine that promotes blood circulation and removes blood stasis, regulates qi and relieves pain. It is used for chest obstruction caused by qi stagnation and blood stasis, symptoms include chest tightness and tingling pain in the precordial area; coronary heart disease angina pectoris. It is prepared from Danshen, Sanqi and Borneol. The preparation method can refer to the pharmacopoeia method. The pharmacokinetic research reports of Compound Danshen Dripping Pills mainly focus on the determination of the pharmacokinetic parameters of effective components such as Danshensu, ginsenoside Rb1, and ginsenoside Rg1 in humans or animals. Kinetic model, determine the relevant pharmacokinetic parameters, and the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01K67/027G16B5/10
CPCA01K67/027G16B5/10A01K2227/105A01K2267/0375
Inventor 孙鹤褚扬柳祖辉马晓慧周水平
Owner TIANJIN TASLY PHARMA CO LTD
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