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인체 혈장에서 염산시프로플록사신(시프로플록사신으로서 250㎎) 정량을 위한 HPLC 분석법의 유효성검토
하용화,조성희,천성국,서성훈,류재환,최영욱,이경태 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.4
A simple HPLC method with ultraviolet detection of ciprofloxacin in human plasma was developed and validated. After protein precipitation with trichloroacetic acid, chromatographic separation of ciprofloxacin in plasma was achieved at 50℃ with a C_18 column and methanol-phosphate mixture (pH 2.5), as mobile phase. Quantitative determination was performed by ultraviolet detection at 278 nm. The method was specific and validated with a limit of quantification of 100 ng/ml. The infra- and inter-day coefficients of variation were between 1.67% and 10.55% and accuracy between 92.01% and 106.09%. The method has been successfully applied in a bioavailability study of 250 ㎎ ciprofloxacin hydrochloride tablet.
레니텍<sup>®</sup> 정(말레인산 에날라프릴, 10 mg)에 대한 에나레이스 정의 생물학적 동등성
조성희,하용화,홍성제,서성훈,류재환,김동현,이경태,Cho, Sung-Hee,Ha, Yong-Hwa,Hong, Sung-Je,Seo, Seong-Hoon,Rew, Jae-Hwan,Kim, Dong-Hyun,Lee, Kyung-Tae 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
The purpose of the present study was to evaluate the bioequivalence of two enalapril maleate tablets, $Renitec^{TM}$ (MSD Korea Ltd.) and $Enalace^{TM}$ (Welfide Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $22.33{\pm}2.55$ year in age and $66.54{\pm}8.30$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg of enalapril maleate per tablet were orally administered, blood was taken at predetermined time intervals and concentrations of enalapril in plasma were determined using LC-MS-MS. Pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;and\;C_{max}$ untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25$(e.g.,\;log1.02{\sim}log1.14\;and\;log1.03{\sim}log1.19\;for\;AUC_t\;and\;C_{max},\;respectively)$. The major parameters, $AUC_t,\;and\;C_{max}$, met the criteria of KDFA for bioequivalence indicating that $Enalace^{TM}$ tablet is bioequivalent to $Renitec^{TM}$ tablet.
레니텍^(�) 정(말레인산 에날라프릴, 10mg)에 대한 에나레이스 정의 생물학적 동등성
조성희,하용화,홍성제,서성훈,류재환,김동현,이경태 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
The purpose of present study was to evaluate the bioequivalence of two enalapril maleate tablets, Renitec^(™) (MSD Korea Ltd.) and Enalace ^(™) (Welfide Korea Ltd.), according to the guidelines of Korea Food Drug Administration (KFDA). Twenty-four normal male volunteers, 22.33±2.55 year in age and 66.54±8.30 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containint 10 ㎎ of enal-april maleate per tablet wre orally administered, blood was taken at predetermined time intervals and concentrations of enalapril in plasma were determined using LC-MS-MS. Pharmacokinetic parameters such as AUC_(t), C_(max) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t) and C_(max) untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transfored data were acceptance range of log0.8 to log1.25(e.g., log1.02∼log1.14 and log1.03∼log1.19 for AUC_(t) and C_(max), respectively). The major parameters, AUC_(t) and C_(max), met the criteria of KDFA for bioequivalence indicating that Enalace^(™) tablet is bioequivalent to Renitec^(™) tablet.