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   全文下載

Application of HPLC Method Using Normal Phase Column in a Comparative Pharmacokinetic Study of Two Sulpiride Tablet Formulations

應用一種配合水性溶媒移動相之正相矽膠管柱以螢光偵測的改良式高效液相層析法於比較兩種市售Sulpiride 錠片處方（Dogmatyl 和Sulpin）的口服藥物動力學。利用十二位健康華人男性自願者，以單劑量，二週期，二個次序、二種交叉試驗設計比較二個產品的相等性試驗。Sulpiride的血漿濃度分析也經簡化為以液相萃取鹼化的血漿樣品，再以此經確效的高效液相層析法檢測。由血漿數據計算的主要藥動學參數包括AUC0-last、AUC0-inf、與Cmax，並利用SAS電腦軟體進行統計分析比較。Two one-sided t distribution和90%可信賴度區間用來比較三個主要參數的平均差異性。結果顯示當口服使用二種單劑量400 毫克的二顆錠片產品具有生體相等性。

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. 應用一種配合水性溶媒移動相之正相矽膠管柱以螢光偵測的改良式高效液相層析法於比較兩種市售Sulpiride 錠片處方（Dogmatyl 和Sulpin）的口服藥物動力學。利用十二位健康華人男性自願者，以單劑量，二週期，二個次序、二種交叉試驗設計比較二個產品的相等性試驗。Sulpiride的血漿濃度分析也經簡化為以液相萃取鹼化的血漿樣品，再以此經確效的高效液相層析法檢測。由血漿數據計算的主要藥動學參數包括AUC0-last、AUC0-inf、與Cmax，並利用SAS電腦軟體進行統計分析比較。Two one-sided t distribution和90%可信賴度區間用來比較三個主要參數的平均差異性。結果顯示當口服使用二種單劑量400 毫克的二顆錠片產品具有生體相等性。