|摘要: ||本研究旨在比較國產sulpiride錠劑與市面標準對照品Dog-matyl®在國人受試者體內動態學上之異同。共有六位成年健康男性(年齡27.6±4.7歲；體重：74.6±7.7公斤)參與本研究，採用重複數量(repeated measure )的設計，每位受試者均於停食一晚後先口服單劑量400mg之Dogmatyl®錠劑，經隔兩週後再口服同劑量之國產錠劑，並於0，0.5，1，1.5，2，4，6，12及24小時抽血，血清中藥品濃度以HPLC方法定量，所得數據以Keitb K.H Chan及Kenneth Wnuck之方法結合本研究室開發之KMCP軟體，以單室模室求出藥物動態學之各項參數。結果顯示Dogmatyl®及國產sulpiride之Cmax分別為1.468±0.631及1.472±0.608 mcg/ml ; Tmax分別為1.50±0.63及1.25±0.61小時; Ke1-24hr：分別為0.087±0.021及0.093±0.024 hr-1 ; Ka0-1 hr分別為3.685±3.000及4.552±2.582hr-1 ；T1/2分別為8.396±1.953及8.013±2.602小時；AUC0-24hr，分別11.03±6.78及8.27±2.99 mcghr/ml及AUC0-∞分別為13.56±9.09及10.11±4.61mcgxhr/ ml，兩者以pairedt- test檢定均不呈有意義差(p>0.05 ).綜合試驗結果，本研究所試驗之國產sulpiride錠劑與Dogmatyl®在國人之體內動態約相似。此外，本研究所採用的劑量為其他研究者未能實施的較高劑量，因更接近臨床上投于精神病之基本劑量，故結果更值得提供此類病人投藥之參考。|
Six healthy male volunteers (age : 276±4.7; weight: 74.6 t7.7) participated in a “ repeated measure" design for comparing the bioavaiability and pharmacokinetic behaviours of the brand-name drug of Dogmatyl® and a generic sulpiride formulation. Each subject recieved a single 400-mg dose of Dogmatyl® in tablet form during the first dosing period. After two weeks of wash-out period, the same dose of a generic out period, the same dose of a generic preparation was then administered. Blood samples were obtained at 0, 0.5, 1, 1.5,2,4, 6, 12 and 24 hours after initial dosing. The concentration of sulpiride was measured by a high pressure liquid chromatographic method using a UV detector. All the data were processed by Keith K.H. Chan and Kenneth Wnuck's method which ultilizes KMCP computer software. Pharmacokinetic parameters were calculated, based on one compartment model. The results revealed that the maximal concentration (Cmax) of Dogmatyl and the generic preparation was 1.468±0.631 and 1.472±0.608 mcg/ml, the time to reach maximal concentration (Tmax) was l.5 t 0.63 and I.25f 0.61 hours, the half life (T1/2) was 8.369±1.95 3 and 8.013t 2.602 hours, the area under curve (from 0 to 24 hours) (AUCO-24h.(from 0 to 24 hours) (AUC0-24hr) was 11.03±6.78 and 8.27±2.99 mcghr/ml, and the area under curve (from 0 hour to infinity)(AUC0-hr) was 13.56±9.09 and 10.11±4.61mcghr/ml, respectively. Based on the data, between the two groups after statistical analysis with paired t-test (p> O.05). There-fore, the similarity of these two formulations is then suggested by the authors. Because a higher single dose of 400mg of sulpiride was administered in the study which was close to achieving the clinical state, therefore, the results may be useful in encouraging the administration of sulpiride to patients with schizophrenic disorders.