进食对健康受试者口服百可利咀嚼片药动学的影响

发布时间：2018-06-04 03:21

  本文选题：黄芩素 + 黄芩苷　； 参考：《中国药学杂志》2015年02期

【摘要】：目的研究在进食和空腹状态下中国健康受试者口服百可利咀嚼片400 mg药动学的差异。方法采用随机、双周期、自身交叉、安慰剂对照设计,12例健康受试者空腹或餐后口服百可利咀嚼片400 mg或安慰剂,HPLC-MS/MS测定血浆中百可利及其主要代谢物黄芩苷的浓度,计算其主要药动学参数并进行安全性评价。结果受试者空腹和餐后口服单剂量百可利后,血浆中百可利的ρmax分别为(15.752±9.328),(19.572±9.439)ng·m L-1;AUC0-t分别为(89.468±48.631),(122.073±28.285)ng·h·m L-1;AUC0-∞分别为(93.356±50.110),(126.212±28.270)ng·h·m L-1。黄芩苷的ρmax分别为(182.472±99.555),(154.782±100.834)ng·m L-1;AUC0-t分别为(1 193.230±693.408),(933.921±282.318)ng·h·m L-1;AUC(0-∞)分别为(1 266.425±866.664),(940.882±286.192)ng·h·m L-1。空腹与餐后各发生4起不良事件,程度均为轻度。结论与空腹服用400 mg百可利咀嚼片相比,进食后百可利的吸收程度增加,而黄芩苷的吸收降低。400 mg耐受性良好,空腹或进食下发生的不良事件相当。吸收程度的改变未影响药物的耐受性。
[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 卤9.328m ~ (-1) AUC _ (0-t), 89.468 卤48.631C ~ (0-t), 122.073 卤28.285)ng / mL ~ (-1) AUC0- 鈭，

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