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 |
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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 、 Sulpiride 、 Normal phase column 、 Bioequivalence 、 HPLC 、 MEDLINE 、 Scopus 、 SCIE |
出刊日期 | 200203 |
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.