http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
약물-고분자물질 결합체 합성연구 : 5-Fluorouracil과 사람의 혈청 Albumin 및 Poly-L-lysine 결합체 합성
이희주,신혜순,이명걸,박만기,김종국,Lee, Hee-Joo,Shin, Hae-Soon,Lee, Myung-Gull,Park, Man-Ki,Kim, Chong-Kook 대한약학회 1989 약학회지 Vol.33 No.5
The durg-macromolecule conjugates i.e. 5-fluorouracil-1-acetyl-human serum albumin(FU-AA-HSA, 8) and 5-fluorouracil-1-acetyl-poly-L-lysine(FU-AA-polylys, 9) have been synthesized and purified by sephadex G-25 gel filtration with 0.05M phosphate buffer(pH 7.5). The analyses of conjugates gave the molar ratio of FU-AA : HSA of 70-100:1 and FU-AA: poly-L-lysine of 109:1. The weight percent of FU-AA(as $FU-CH_2CO-$) in FU-AA-HSA conjugate was 16-22% and the one in FU-AA-polylys was 22.4%.
이영주(Young Joo Lee),김윤균(Yoon Goon Kim),이명걸(Myung Gull Lee),정석재(Suk Jae Chung),이민화(Min Hwa Lee),심창구(Chang Koo Shim) 대한약학회 2000 약학회지 Vol.44 No.4
Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).
Haloperidol의 약물속도론적 연구 (III) -정신분열증 환자에 있어서 Haloperidol의 일회 주사 및 경구투여시의 Pharmacokinetics-
박경호(Kyoung Ho Park),이민화(Min Hwa Lee),이명걸(Myung Gull Lee),권준수(Jun Soo Kwon),박원명(Won Myung Park),박진생(Jin Seng Park) 대한약학회 1990 약학회지 Vol.34 No.6
The pharmacokinetics of haloperidol were determined after single oral and intravenous doses in 13 male schizophrenic patients. Plasma concentrations of haloperidol(HP) and reduced haloperidol were measured by high performance liquid chromatography. Plasma concentration data obtained were analyzed by obth model dependent (one-or two exponential decay models using nonlinear regression) and model independent (AUC and first moment curve) approaches. The two methods were found to be in close results. After intravenous injections of HP in 8 patients (10 mg/man), the mean central and peripheral volume of distribution were 2.85+/-1.7O and 8.09+/-2.10 l/kg, respectively, and mean steady, state volume of distribution was 11.87+/-3.21 l/kg. Mean clearance, MRT and elimination half life were 12.39+/-3.25 ml/min/kg, 925.1O+/-166.79 min and 676.35+/-126.45 min,respectively. After oral administrations of HP in 5 patients, mean peak time and peak concentration were 2l7.63+/-61.60min and 9.77+/-2.92ng/ml, respectively. Mean MRT and elimination half life were 1112.23+/-131.73 min and 724.02+/-120.03 min, respectively, and these parameters were not significantly different from those of intravenous injection of HP. Absolute bioavailability of HP oral product was found to be about 44%. The profiles of plasma RH concentration-time curves after oral or intravenous doses of HP were similar. Also it was found that the elimination rate of RH was slower than that of HP by comparing the slopes of plasma concentration-time curves of HP and RH.
정상 성인에 있어서 미배아 발효액 (Glumate)이 에탄올의 혈중농도에 미치는 영향
김영철(Young Chul Kim),박성호(Seong Ho Park),이명걸(Myung Gull Lee) 대한약학회 1993 약학회지 Vol.37 No.5
The extracts fermented of rice germ are called GMT (Glumate) which is a main ingredient of Condition(R) . It has been reported that GMT reduced the blood concentrations of alcohol in heathy adults. The purpose of the study is to examine the effect of GMT on blood concentrations of ethanol and on heart rate increase induced by ethanol. GMT was administered orally to 15 healthy adults before (10 min) and after (1 h) ethanol ingestion. The oral administration of GMT before (10 min) and after (1 h) ethanol ingestion reduced the area under the blood concentration of ethanol-time curve (p<0.12) and tended to inhibit the ethanol-induced heart rate increase.
피하주사 및 국소도포시 [14C]DA-5018 의 약동력학
김원배(Won Bae Kim),양중익(Junn Ick Yang),이상득(Sang Deuk Lee),이응두(Eung Doo Lee),심현주(Hyun Joo Shim),이종진(Jong Jin Lee),이명걸(Myung Gull Lee) 한국응용약물학회 1997 Biomolecules & Therapeutics(구 응용약물학회지) Vol.5 No.1
Pharmacokinetics of a new capsaicin analog, DA-5018 were evaluated after a subcutaneous injection or topical application of ^(14)C-labelled or unlabelled DA-5018 to rats and rabbits. After subcutaneous injection of ^(14)C-labelled or unlabelled DA-5018, 0.5 mg/kg (equivalent to DA-5018) to rats, the plasma total activity peaked at 2 hr with the terminal half life of 5.34 hr, however, unlabelled-DA-5018 peaked at 1 hr with the terminal half life of 1.26 hr. Moreover, the AUC (0.726 versus 0.233 ㎍ hr/ml) and MRT (7.82 versus 3.55 hr) increased significantly based on total radioactivity compared with intact DA-5018. Above data indicated that DA-5018 is extensively metabolized in rats and the terminal half- life of the metabolites) had a longer half-life than that of DA-5018. The cumulative percentages of biliary excretion of dose after subcutaneous injection of [^(14)C]DA-5018 was 40.2%, however, the value was only 2.14% when unlabelled DA-5018 was injected. After topical application of 0.1% or 0.3% ^(14)C-labelled or unlabelled DA-5018 cream, 500 mg/kg to rats, the plasma and tissue concentrations except applied skin were under the detection limit. After consecutive 7 days topical application of unlabelled DA-5018, 0.1% and 0.3% cream to rats, the plasma concentrations were also under the detection limit. But the urinary excretion of DA-5018 was significantly increased by repeated topical administration. After topical application of unlabelled DA-5018, 0.1% and 0.3% cream to rabbits, the plasma and urine concentrations were under the detection limit. Above data indicated that the skin permeation of DA5018 was lower and the metabolism of DA-5018 was higher in rabbits than that in rats.
이민화,이영주,심창구,정석재,이명걸 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.1
A 3×3 Latin square crossover study for the bioequivalence of three ondansetron formulations was conducted. Test products were Vominon^ⓡ 8 ㎎ and Vominon^ⓡ ㎎ tablets and reference product was Zofran^ⓡ tablet. Twenty one healthy Korean male subjects received each formulation at the ondansetron dose of 8 ㎎ and plasma concentrations of ondansetron were monitored by HPLC for over a period of 12 hr after the oral administration. Statistical procedure for bioequivalence evaluation of AUC {e.g., analysis of variance (ANOVA), multiple comparison and confidence intervals} was carried out. There were no significant differences in AUC among the formulations. The confidence intervals for the AUC of Vominon^ⓡ 8 ㎎ and Vominon^ⓡ 4 ㎎ were between -0.24 and 15.54% and between -2.41 and 13.36% respectively, within a range that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence. These statistical procedure could be standardized and generally applicable for the assessment of bioequivalence for multiple (more than two) formulations.
이민화,박경호,심창구,이명걸,박종세 한국약제학회 1992 Journal of Pharmaceutical Investigation Vol.22 No.3
A gas chromatographic method using nitrogen phosphorous selective detection was developed for simultaneous determination of haloperidol and its metabolite, reduced haloperidol, in human plasma. Combelen was used as internal standard. The method involved extraction and trimethylsilylation followed by the injection of 2-4 ㎕ of benzene layer, which was used to dissolve the trimethylsilylated derivatives of haloperidol and reduced haloperidol, onto SE-54 column [5% phenyl methyl silica fused capillary column, 16m×0.22 mm (I.D.)×0.33 μm (coated thickness)]. The temperature of column oven was programmed from 200℃ to 300℃ at the increase rate of 10℃/min, and also the temperatures of injector and detector were set at 300℃. Helium was used as carrier gas and its flow rate was maintained at 30 ml/min. The detection was conducted with nitrogen phosphorous selective detector. The retention times for combelen, reduced haloperidol and haloperidol were found to be 9.14, 9.75 and 9.99 min, respectively. The detection limits for haloperidol and reduced haloperidol in human plasma were both 0.2 ng/㎖. The coefficients of variation of the intra-assay were generally low (below 9.8%). The mean absolute recoveries of added haloperidol and reduced haloperidol from plasma were 72% and 84%, respectively. No interferences from endogenous substances were found.