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음이온계 약물의 간수송과정에 있어서 대향수송의 약물동력학적 모델링 및 시뮬레이션
송석길(Sukgil Song),이준섭(Jun Seup Lee),정연복(Youn Bok Chung) 대한약학회 2005 약학회지 Vol.49 No.4
The purpose of the present study was to kinetically investigate the carrier-mediated uptake in the hepatic transport of organic anions, and to simulate the "in vivo counter-transport" phenomena, using kinetic model which was developed in this study. The condition that the mobility of carrier-ligand complex is greater than that of free carrier is not essential for the occurrence of "counter-transport" phenomenon. To examine the inhibitory effects on the initial uptake of organic anions by the liver, it is necessary to judge whether the true counter-transport mechanism (trans-stimulation) is working or not. Effects of bromophenol blue (BPB) or bromosulfophthalein (BSP) on the plasma disappearance curves of a 1-anilino-8-naphthalene sulfonate (ANS) were then kinetically analyzed based on a flow model, in which the ligand is eliminated only from the peripheral compartment (liver compartment). Moreover "in vivo counter-transport" phenomena were simulated based on the perfusion model which incorporated the carrier-mediated transport and the saturable intracellular binding. The "in vivo counter-transport" phenomena in the hepatic transport of a organic anions were well demonstrated by incorporating the carrier-mediated process. However, the "in vivo counter-transport" phenomena may be also explained by the enhancement of back diffusion due to the displacement of intracellular binding. In conclusion, one should be more cautious in interpreting data obtained from so-called "in vivo counter-transport" experiments.
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타라신 근주(케토롤락트로메타민 30 mg)에 대한 케로라 근주의 생물학적 동등성
한건,정연복,이준섭 한국약제학회 1999 Journal of Pharmaceutical Investigation Vol.29 No.1
A bioequivalence study of the Kerola^ⓡ intramuscular injections (Dongkwang Pharmaceutical Co., Korea) to the Tarasyn^ⓡ intramuscular injections (Roche Co., Korea), formulations of ketorolac tromethamine (KTR), was conducted. Sixteen healthy Korean male subjects were received each formulation at the dose of 30 ㎎ as KTR in a 2×2 crossover study. There was an one-week washout period between the doses. Plasma concentrations of KTR were monitored by a HPLC method. AUC was calculated by the linear trapezoidal method. C_(max) and T_(max) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, C_(max) and T_(max) between the formulations. The differences between the formulations in these parameters were all far less than 20% (i.e., 3.65, 2.59 and 4.35% for AUC, C_(max) and T_(max), respectively). Minimum detectable differences (%) at α=0.1 and 1-β=0.8 were 12.87, 13.44, 20.62%, for AUC, C_(max) and T_(max), respectively. The 90% confidence intervals for these parameters were also within 20%. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the two formulations of KTR are bioequivalent.
ScienceON
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