中国临床药学杂志

目的研究氨氯地平片在健康志愿者体内的药动学及其生物等效性。方法采用随机双交叉试验设计,18名健康受试者口服受试制剂和参比制剂5 mg,用HPLC-MS法测定血浆中氨氯地平浓度。结果受试制剂和参比制剂的主要药动学参数:AUC0→t分别为(152.73±44.50)和(147.02±40.65)μg.h.L-1;AUC0→∞分别为(167.92±50.71)和(161.56±46.56)μg.h.L-1;ρmax分别为(3.93±0.75)和(3.87±0.91)μg.L-1;tmax分别为(6.6±2.3)和(6.0±1.4)h;t12分别为(34.34±6.43)和(34.11±4.62)h。受试制剂的相对生物利用度为(104.0±11.3)%。结论氨氯地平片的受试制剂和参比制剂具有生物等效性。

AIM To study the pharmacokinetics and relative bioavailability of amlodipine tablets in Chinese healthy volunteers.METHODS Eighteen male healthy volunteers received 5 mg amlodipine tablets orally in a random crossover design.Drug concentrations in plasma were determined by HPLC-MS.RESULTS The main pharmacokinetic parameters of tested tablet and reference tablet were as follows: AUC0→t:(152.73±44.50) vs(147.02±40.65)μg·h·L-1,AUC0→∞:(167.92±50.71) vs(161.56±46.56)μg·h·L-1,ρmax:(3.93±0.75) vs(3.87±0.91)μg·L-1,tmax:(6.6±2.3) vs(6.0±1.4)h,t12:(34.34±6.43) vs(34.11±4.62)h,respectively.The relative bioavailability of the test tablet was(104.0±11.3)%.CONCLUSION The results demonstrate that the tested tablet and reference tablet are bioequivalent.