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인체에서 carvedilol의 심혈관계 작용에 대한 PK/PD modeling
백인환,윤민혁,윤휘열,남진경,권광일 충남대학교 약학대학 의약품개발연구소 2007 藥學論文集 Vol.22 No.-
The objective of the present study was to determine and characterize the relationship between the cardiovascular effect and plasma concentration of carvedilol by PK/PD modeling in human. A group of 32 healthy males received oral doses of 25 mg carvedilol, and blood samples were collected thirteen times for up to 30 hours after the drug administration. The effect of carvedilol on blood pressure was measured during the same period. This experiment was analyzed using the liquid-liquid extractions of carvedilol by HPLC with fluorescence detection. Pharmacokinetics parameters of carvedilol were calculated using the two-compartment model with first-order absorption. The average value of C_(max), T_(max), CL/F (apparent clearance), V/F (apparent volume of distribution) and half-life of carvedilol were 62.74 ± 20.12 ng/ml, 1.26 ± 0.86 hrs, 94.64 ± 46.01 L/hr, 1561.78 ± 941.94 L, 12.47 hr, respectively. To explain the relationship between the cardiovascular effect and plasma concentration of carvedilol, plasma drug concentrations were linked to the observed SBP and DBP via a effect compartment with a sigmoid Emax model. The model parameters were estimated by using ADAPT Ⅱ program. This PK/PD model could describe the relationship between plasma concentrations of carvedilol and cardiovascular effect such as the aspects of decreasing blood pressure and the time delay between plasma concentration and pharmaco-dynamic data.