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액체크로마토그래프법에 의한 사람 혈장 중 테라조신의 정량 및 테라토닌? 정의 생물학적 동등성
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  • 액체크로마토그래프법에 의한 사람 혈장 중 테라조신의 정량 및 테라토닌? 정의 생물학적 동등성
저자명
조은숙,강성하,전인구,Cho. Eun-Sook,Kang. Sung-Ha,Chun. In-Koo
간행물명
藥劑學會誌
권/호정보
2002년|32권 2호|pp.119-125 (7 pages)
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한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{sim}60;ng/ml$ were $0.49{sim}2.92;and;0.38{sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{pm}2.0;years;old)$ were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in plasma was determined with a HPLC method using spectrofluorometric detector. 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) was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,;C_{max};and;T_{max}$ between the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{eta});for;AUC_t,;C_{max};and;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({Delta},;%);at;{alpha}=0.1;and;1-{eta}=0.8$ and the 90% confidence intervals were all less than ${pm}20%$ except for $T_{max}.;AUC_t;and;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.