Method for deriving exposure characteristics of compounds in plasma from urine excretion curve

A compound and plasma technology, applied in the field of pharmacokinetics research, can solve the problems of large sample size, inability to accurately describe the individual plasma drug-time curve, large variation, etc., and achieve the effect of solving the difficulty of blood collection

Pending Publication Date: 2021-05-25
ACADEMY OF MILITARY MEDICAL SCI
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Problems solved by technology

The advantage of the former is direct data, and the disadvantage is large variation, large sample size, and long data collection
The advantage of the latter is mechanistic modeling, and the disadvantage is the use of indirect data to produce predictive results. Neither of them can accurately describe the drug-time curve of individual plasma. Therefore, we propose a method to deduce the exposure characteristics of compounds in plasma from the urine excretion curve

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  • Method for deriving exposure characteristics of compounds in plasma from urine excretion curve
  • Method for deriving exposure characteristics of compounds in plasma from urine excretion curve
  • Method for deriving exposure characteristics of compounds in plasma from urine excretion curve

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Embodiment Construction

[0029] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention.

[0030] In a single-dose intravenous administration, the in vivo disposition of the test drug conforms to the first-order elimination kinetics, and the total clearance conforms to the linear elimination characteristics within the range of the test dose and in vivo exposure; there is renal excretion elimination and conforms to the linear elimination characteristics; the above assumptions , the in vivo drug dose-time curve of the two-compartment distribution model follows Equation 1

[0031] X=Ae -αt +Be -βt 1

[0032] Urine Drug Excretion Rate Equation 2

[0033]

[0034] Find the realistic solution of Equation 2, and obtain the cumulative excretion time curve o...

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Abstract

The invention discloses a method for deriving exposure characteristics of compounds in plasma from urine excretion data, which comprises the following steps of: under the condition of single-dose or multi-dose intravenous injection (including infusion) or oral administration, fitting a two-atrioventricular distribution model or a three-atrioventricular distribution model aiming at a urine excretion curve by utilizing a semi-logarithmic end linear regression method; and calculating the urine clearance rate CLr by adopting single-point plasma drug concentration data to correct and finally acquire a plasma drug concentration-time curve. According to the method, urine excretion data and single-point plasma drug concentration data are obtained through non-invasive sampling, a plasma exposure curve is fitted and reversely deduced through a mathematical means, and the bottleneck problem that blood sampling is difficult in pharmacokinetic research of special crowds is solved.

Description

technical field [0001] The invention belongs to the technical field of pharmacokinetic research, and in particular relates to a method for deducing the exposure characteristics of compounds in plasma from urine excretion curves. Background technique [0002] Drug exposure in the central compartment is the primary basis for judging the disposition of drugs in vivo, and is the core of pharmacokinetic research. Therefore, the plasma drug concentration-time curve is the "key data" of pharmacokinetic research. In order to obtain this data, subjects usually need to collect blood samples at least 10 time points for quantitative analysis after administration, so as to fully display the plasma drug concentration time curve. However, for special populations, such as children, the elderly, diseases, etc., due to ethical restrictions or their own (other) reasons, intensive blood collection cannot be performed, which greatly hinders the pharmacokinetic research of these populations. [...

Claims

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Application Information

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IPC IPC(8): G16C10/00
CPCG16C10/00
Inventor 张天宏张文鹏庄笑梅
Owner ACADEMY OF MILITARY MEDICAL SCI
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