進(jìn)食對健康受試者口服百可利咀嚼片藥動學(xué)的影響
發(fā)布時間:2018-06-04 03:21
本文選題:黃芩素 + 黃芩苷; 參考:《中國藥學(xué)雜志》2015年02期
【摘要】:目的研究在進(jìn)食和空腹?fàn)顟B(tài)下中國健康受試者口服百可利咀嚼片400 mg藥動學(xué)的差異。方法采用隨機(jī)、雙周期、自身交叉、安慰劑對照設(shè)計,12例健康受試者空腹或餐后口服百可利咀嚼片400 mg或安慰劑,HPLC-MS/MS測定血漿中百可利及其主要代謝物黃芩苷的濃度,計算其主要藥動學(xué)參數(shù)并進(jìn)行安全性評價。結(jié)果受試者空腹和餐后口服單劑量百可利后,血漿中百可利的ρmax分別為(15.752±9.328),(19.572±9.439)ng·m L-1;AUC0-t分別為(89.468±48.631),(122.073±28.285)ng·h·m L-1;AUC0-∞分別為(93.356±50.110),(126.212±28.270)ng·h·m L-1。黃芩苷的ρmax分別為(182.472±99.555),(154.782±100.834)ng·m L-1;AUC0-t分別為(1 193.230±693.408),(933.921±282.318)ng·h·m L-1;AUC(0-∞)分別為(1 266.425±866.664),(940.882±286.192)ng·h·m L-1?崭古c餐后各發(fā)生4起不良事件,程度均為輕度。結(jié)論與空腹服用400 mg百可利咀嚼片相比,進(jìn)食后百可利的吸收程度增加,而黃芩苷的吸收降低。400 mg耐受性良好,空腹或進(jìn)食下發(fā)生的不良事件相當(dāng)。吸收程度的改變未影響藥物的耐受性。
[Abstract]:Objective to study the pharmacokinetic differences between Chinese healthy volunteers and healthy Chinese volunteers in taking buccal chewable tablets (400 mg). Methods A randomized, double-cycle, self-crossover, placebo-controlled study was conducted in 12 healthy volunteers to determine the concentration of buconil and its main metabolite baicalin in plasma of 12 healthy subjects by oral administration of BAC 400 mg or placebo HPLC-MS / MS on an empty stomach or postprandial basis. The main pharmacokinetic parameters were calculated and safety evaluation was carried out. Results the 蟻 max of paracorb in plasma was 15.752 鹵9.328m ~ (-1) AUC _ (0-t), 89.468 鹵48.631C ~ (0-t), 122.073 鹵28.285)ng / mL ~ (-1) AUC0- 鈭,
本文編號:1975633
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