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藥物食品分析 MEDLINESCIEScopus

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篇名 應用正相矽膠管柱的高效液相層析法於二種Sulpiride錠片處方的藥物動力學比較
卷期 10:1
並列篇名 Application of HPLC Method Using Normal Phase Column in a Comparative Pharmacokinetic Study of Two Sulpiride Tablet Formulations
作者 黃明權何秀娥葉健全柯文庭林麗卿許德滿許明照
頁次 1-6
關鍵字 正相矽膠管柱生體相等性高效液相層析法SulpirideNormal phase columnBioequivalenceHPLCMEDLINEScopusSCIE
出刊日期 200203

中文摘要

英文摘要

An HPLC method using normal phase column eluted with an aqueous solvent and detected by fluorescence was applied to analyze sulpiride concentrations in plasma samples obtained from a comparative pharmacokinetic study. This comparative study was conducted to determine the bioequivalence of two tablet products (Dogmatyl and Sulpin) containing sulpiride on 12 normal healthy Chinese male volunteers
in a single-dose, two-period, two-sequence, two-treatment crossover design. The pharmacokinetic parameters, AUC0-last, AUC0-inf, and Cmax, were calculated from plasma data and compared using the SAS General Linear Model computer program. A two onesided t distribution test was also performed, as well as the 90% confidence interval method, to determine the mean difference of these three pharmacokinetic parameters. The results suggest that these two sulpiride tablet products are bioequivalent when orally administered in a 400 mg single dose of two tablets.

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