扎来普隆片的人体药动学研究

Pharmacokinetics of Zaleplon Tablets in Chinese Healthy Volunteers

目的 :研究国产扎来普隆片在中国人体内的药动学特征。方法 :20名健康志愿者单剂量口服15mg 扎来普隆片后 ,采用高效液相色谱法测定其血浆中扎来普隆浓度。结果与结论 :扎来普隆供试片药 -时曲线符合一房室模型 ,其Cmax 为 (55 90±16 20)ng/ml ,Tmax 为 (1 05±0 32)h ,Ke为 (0 74±0 18)h -1,T1/2ke 为 (1 00±0 29)h ,AUC0～8 为 (123 70±25 64) (ng·h)/ml,AUC0～∞为 (125 20±25 80) (ng·h)/ml ,与国外文献报道基本一致。

OBJECTIVE:To study the pharmacokinetics of domestic zaleplon tablets in Chinese healthy volunˉteers.METHODS:20male healthy subjects received a single oral dose of15mg zaleplon tablets.The plasma concentrations of zaleplon were determined by an improved HPLC method.RESULTS&CONCLUSION:The main pharmacokinetic parameters of zaleplon were as follow:C max was55.90±16.20ng/ml,T max was1.05±0.32h,Ke was0.74±0.18h -1 ,T 1/2Ke was1.00±0.29h,AUC 0～8 was123.70±25.64ng·h/ml,AUC 0～∞ was125.20±25.80ng·h/ml.The results are comparaˉble to those reported in foreign literature.