【摘要】 目的评价苯磺酸左旋氨氯地平片(分散片)在健康人体内的药物动力学与生物等效性。方法18名健康志愿者随机交叉单剂量口服左旋氨氯地平后,取血,采用LC-MS-MS法测定血浆中药物浓度。结果单次口服左旋氨氯地平片(参比、受试)和左旋氨氯地平分散片(受试)5 mg后的Cmax分别为(2.106±0.433)、(2.062±0.447)和(2.148±0.419)ng.mL-1;tmax分别为(5.2±1.1)、(5.1±0.7)和(4.9±0.8)h;AUC0→120分别为(72.962±18.884)、(70.986±16.237)和(68.955±19.200)ng.h.mL-1。受试制剂相对于参比制剂的生物利用度F分别为(98.7%±11.7%)和(95.2%±12.3%)。结论受试制剂苯磺酸左旋氨氯地平片(片及分散片)与参比制剂苯磺酸左旋氨氯地平片(施慧达)具有生物等效性。更多还原

【Abstract】 Objective To evaluate the bioequivalence of Levamlodipine Besylate tablets.Methods According to the cross-over design,each volunteer was given a single oral dose of levamlodipine besylate tablets and then the plasma was obtained and determined by LC-MS-MS method.Results The main pharmacokinetic parameters of single dose of the three products were as follows: Cmax was(2.106±0.433),(2.062±0.447)and(2.148±0.419)ng·mL-1,tmax was(5.2±1.1),(5.1±0.7)and(4.9±0.8)h,AUC0→120 was(72.962±18.884),(70.986±16.237)and(68.955±19.200)ng h·mL-1 for reference and test respectively.The relative bioavailability was(98.7%±11.7%)and(95.2%±12.3%),respectively.Conclusion The levamlodipine besylate tablets were bioequivalent.更多还原