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Acarbose 제제의 약력학적 평가 및 생물학적동등성 시험법에 대한 연구
배정우,장춘곤,이석용,Bae, Jung-Woo,Jang, Choon-Gon,Lee, Seok-Yong 대한약학회 2007 약학회지 Vol.51 No.6
Arcabose is a competitive inhibitor of the intestinal ${\alpha}$-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over ($3{\times}3$) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug ($Glucoby^{(R)}$ 100 mg, Lot # D043) or test drug ($Glucoby^{(R)}$ 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. $C_{max},\;AUC_{0-2},\;AUC_{0-4},\;{\Delta}C_{max},\;{\Delta}AUC_{0-2}\;and\;{\Delta}AUC_{0-4}$ of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.
와파린의 HPLC 분석법 및 한국인에서의 약동학적 특징
배정우,김현경,양상인,김지홍,김경혜,장춘곤,박영서,손의동,이석용,Bae, Jung-Woo,Kim, Hyun-Kyung,Yang, Sang-In,Kim, Ji-Hong,Kim, Kyung-Hye,Jang, Choon-Gon,Park, Young-Seo,Sohn, Uy-Dong 대한약학회 2005 약학회지 Vol.49 No.2
Warfarin is a widely used oral anticoagulant agent used to treat thromboembolic disease. The purpose of this study was to develop the efficient assay method of warfarin sodium i n human plasma and to assess the pharmacokinetic profile of the warfarin in healthy Korean volunteers. The pharmacokinetics of warfarin administered orally was evaluated after a dose of 10 mg. Warfarin in plasma was assayed using a specific HPLC method with UV absorbance at 304 nm. AUC was 46.33${\pm}9.95{\mu}g/ml.hr$, $C_{max}$ $1.22{\pm}0.22{\mu}g/ml, $T_{max}$$2.50{\pm}1.41$ hr and half-life $43.49{\pm}4.33$ hr. $T_{max}$ was slightly shorter than that in Caucasian (3~9 hr), whereas the half-life was longer than that in Caucasian (10~45 hr, mean: 36 hr). These results suggest that warfarin may have a longer duration in Korean than in Caucasian.
에토석시미드의 HPLC 분석법 및 한국인에서의 약동학적 특징
배정우(Jung-Woo Bae),김지홍(Ji-Hong Kim),양상인(Sang-In Yang),김현경(Hyun-Kyung Kim),장춘곤(Choon-Gon Jang),한혜원(Hye-Won Han),박영서(Young-Seo Park),손의동(Uy-Dong Sohn),이석용(Seok-Yong Lee) 대한약학회 2003 약학회지 Vol.47 No.6
Ethosuximide is an oral anticonvulsantic agent used in the first choice anti-absence seizure drug. The purpose of this study was to assess the pharmacokinetic profile of the ethosuximide in healthy Korean volunteers and to develop the efficient assay method of ethosuximide in human plasma. The pharmacokinetics of ethosuximide administered orally was evaluated after a dose of 500 mg. Ethosuximide was assayed from plasma by a specific HPLC method reading absorbance at 195 nm. AUC was 1222±160 μg/ml·hr, Cmax 14.21±1.74 μg/ml, Tmax 1.06±0.62 hr and half-life 77.83±12.46 hr. The half-life in Korean was longer than, in Caucasian (53~56 hr).
Urinary Trypsin Inhibitor ( UTI ) 의 일반약리작용
성연희(Yeon Hee Seong),조순옥(Sun Ok Jo),이선애(Seon Ae Lee),임화경(Hwa Kyung Lim),장춘곤(Choon Gon Jang),김학성(Hack Seang Kim),강종구(Jong Koo Kang) 한국응용약물학회 1996 Biomolecules & Therapeutics(구 응용약물학회지) Vol.4 No.4
General pharmacological properties of urinary trypsin inhibitor (UTI) following intravenous administration of 1,000,000 units/㎏ were examined in terms of effects on central nervous system, cardiovascular system, respiratory system, gastrointestinal system in mice, rats and rabbits. Administration of UTI (1,000,000 units/㎏, iv) had no effect on central nervous system; no influences on pentobarbital sleeping time, spontaneous activity, normal body temperature, chemoshock produced by pentylenetetrazole solution, writhing syndromes induced by 0.6% acetic acid solution, and motor coordination of mice. The administration of UTI (1,000,000 units/㎏, iv) in rats had no effect on systolic blood pressure and pulse rate. UTI (500,000 units/㎏, iv) given to anesthetized rabbits showed no effect on respiratory rate. However, it showed significant elevation of respiratory rate at the concentration of 1,000,000 units/㎏. Gastric secretion of rat and intestinal motility of mice were not influenced by the dose of 1,000,000 units/㎏. In terms of autonomic nervous system, the material did not show direct effect and inhibitory or augmentative action of histamine- or acetylcholine-induced contraction at the concentration of 2,000 units/ml in the isolated ileum of guinea pig.
박창선(Chang Sun Park),배성미(Seong Mee Bae),양성희(Seong Hee Yang),황보신이(Shinn Hwangbo),홍경자(Kyung Ja Hong),장춘곤(Choon Gon Jang),이석용(Seok Yong Lee) 대한약학회 2002 약학회지 Vol.46 No.1
The elderly patients are the most frequent users of digoxin because of increased prevalence of the two primary indications for digoxin therapy; atrial fibrillation (AF) and congestive heart failure (CHF). This study was Performed to observe a variation in digoxin pharmacokinetic parameters in advancing age and changing kidney function, and to compare the measured clearance with the calculated clearance. The 123 drug monitoring records of inpatients who had achieved steady state concentration of digoxin at a tertiary hospital from April 1999 to October 2001 were reviewed. In advancing age, measured digoxin clearance, volume of distribution and creatinine clearance were reduced. Compared with the calculated digoxin clearance, the measured digoxin clearance was more reduced in patients without CHF Especial1y: in elderly patents without CHF the measured digoxin clearance was lower than the calculated digoxin clearance. In contrast to non-CHF patients the measured value was greater than the calculated value in all CHF patients. Findings from this study indicate that the calculated digoxin clearance in elderly patients without CHF substantially overestimated the true clearance. Thus, it appears that the use of calculated digoxin clearance to estimate serum digoxin concentration may result in underestimation of the true serum concentration in a number of elderly patients without CHF.
프로카인아미드의 HPLC 분석법 및 한국인에서의 약동학적 특징
배정우(Jung-woo Bae),김현경(Hyun-Kyung Kim),양상인(Sang-In Yang),김지홍(Ji-Hong Kim),김경혜(Kyung-Hye Kim),장춘곤(Choon-Gon Jang),박영서(Young-Seo Park),손의동(Uy-Dong Sohn),이석용(Seok-Yong Lee) 大韓藥學會 2005 약학회지 Vol.49 No.3
Procainamide is the drug of second choice (after lidocaine) in most coronary care units for the treatment of sustained ventricular arrhythmias associated with acute myocardial infarction. The purpose of this study was to develop the efficient assay method of procainamide in human plasma and to assess the pharmacokinetic profile of procainamide in healthy Korean volunteers. The pharmacokinetics of procainamide administered orally was evaluated after a dose of 250 mg. Procainamide in plasma was assayed using a specific HPLC method with UV absorbance at 275nm. AUC was 4.58±0.90 μg/ml.hr, Cmax 1.34±0.39 μg/ml, Tmax 1.06±0.34 hr and half-life 3.07±0.34 hr. Tmax was slightly shorter than that in Caucasian (1~2hr), whereas the half-life was similar to that in Caucasian (2.5~4.1 hr).
Jang, Choon-Gon,Kang, Moonkyu,Cho, Jae-Han,Lee, Sun-Bok,Kim, Hyuntaek,Park, Soonkwon,Lee, Jinwoo,Park, Seong-Kyu,Hong, Moochang,Shin, Min Kyu,Shim, In-Sup,Bae, Hyunsu WHO COLLABORATING CENTRE FOR TRADITIONAL MEDICINE 2004 東西醫學硏究所 論文集 Vol.2004 No.-
Depression is associated with a dysfunctional serotonin (5-hydroxytryptamine; 5-HT) system. More recently, several lines of evidence suggest that an important factor in the development of depression may be a deficit in the function and expression of 5-HT_(1A) receptors. The present study assessed if Nelumbinis Semen (N. s.) had an anti-depression effect through reversing a decrease in 5-HT_(1A) receptor binding in rats with depression-like symptoms induced by chronic mild stress. Using a 5-HT_(1A) receptor binding assay, with a specific 5-HT_(1A) receptor agonist, 8-OH-DPAT (8-hydroxy-2-(di-n-propylamino) tetralin), the mechanism of the anti-depression effect of N. s. on rats was investigated, and the effects compared with two well-known antidepressants, Hyperium Perforatum (St. Johns Wort) and fluoxetine (Prozac). Animals were divided into live groups: the normal (N) group without chronic mild stress (CMS), the control (C) group under CMS for 8 weeks, the Nelumbinis Semen (N. s.) treatment group under CMS for 8 weeks, the Hyperium Perforatum (H. p.) treatment group under CMS for 8 weeks and finally, the fluoxetine (F) treatment group under CMS for 8 weeks. Each treatment was administered to rats during the last 4 weeks of the 8-week CMS. A sucrose intake test was performed to test the anti-depression effect of N. s. The N. s. treatment significantly reversed the decreased sucrose intake under CMS (P<0.05 compared to control group under CMS). In the CA2 and CA3 regions of the hippocampus, both N. s. and H. p. reversed the CMS-induced decrease in 5-HT_(1A) receptor binding. In the Ⅰ to II regions of the frontal cortex, N. s. and H. p. also reversed the CMS-induced decrease in 5-HT_(1A) receptor binding, and even showed a significant increase in 5-HT_(1A) receptor binding compared to the F treatment group (N. s. vs. P₁ p<0.05, H. p. vs. P₁ p<0.05). However, in the hypothalamus, all treatments reversed the CMS-induced decrease in 5-HT_(1A) receptor binding. This reversal effect of N. s. on the decrease in 5-HT_(1A) receptor binding in the frontal cortex, hippocampus and hypothalamus of rat brains was very similar to that of H. p, but different from that of F. It is concluded that N. s. presents an anti-depression effect through enhancing 5-HT_(1A) receptor binding.