摘要
目的研究2种苯磺酸氨氯地平片的相对生物利用度及其生物等效性。方法采用双周期、随机、交叉试验设计,将20名男性健康受试者随机分成2组,单剂量、交叉口服受试制剂及参比制剂苯磺酸氨氯地平片10 mg,采集不同时间点的静脉血样,用超高效液相色谱—串联质谱法测定给药后不同时间氨氯地平的血药浓度。结果受试试剂及参比试剂的主要药代动力学参数如下:Tmax分别为(6.32±0.85)h和(5.95±1.23)h;Cmax分别为(6.231±1.734)ng·mL-1和(6.138±1.352)ng·mL-1;T1/2分别为(39.89±9.43)h和(40.02±7.49)h;AUC0-144分别为(273.473±97.167)ng·h·mL-1和(278.314±80.340)ng·h·mL-1;AUC0-∞分别为(303.480±106.054)ng·h·mL-1和(306.412±91.351)ng·h·mL-1。受试制剂对参比制剂的相对生物利用度为(99.7±20.2)%。统计分析结果表明2种苯磺酸氨氯地平片在不同制剂间和不同周期间差异无统计学意义(P>0.05)。结论苯磺酸氨氯地平片的受试制剂与参比制剂具有生物等效性。
Objective To evaluate the pharmacokinetics and bioavailability of two formulations of amlodipine tablets in 20 healthy male volunteers. Methods A total of 20 healthy male volunteers were orally given a single dose of l0 nag of two different formulations of amlodipine in an open ran- domized cross-over test. The arnlodipine concentration in plasma was determined by ultrapefformanee liquid chromatography-tandem mass spectrom- etry. Results The main pharmaeokinetie parameters of tested and reference tablets were as follows ： Tmax of arnlodipine were 6.32±0.85 h and 5.95±1.23 h, Cmax were 6.231±1.734 ng· mL-1 and 6.138±1.352 ng· mL-1, T2/1 were 39.89±9.43 h and 40.02±7.49 h and AUCo ~ were 273.473±97.167 ng. h- mL^-1 and 278.314~80.340 ng. h＂ mL^-1, AUCo-∞were 303.480±106.054 ng· h. mL-1and 306.412±91.351 ng. h＂ mL^-1, respectively. The rela- tive bioavailability was 99.7%-＋20.2%. Conclusion The results demonstrate that the tested and reference tablets are bioequivalent.
出处
《中国医科大学学报》
CAS
CSCD
北大核心
2014年第1期22-25,共4页
Journal of China Medical University
基金
国家自然科学基金(81173123)
关键词
氨氯地平片
相对生物利用度
生物等效性
超高效液相色谱一串联质谱法
amlodipine besylate tablets
relative bioavailability
bioequivalence
uhraperformance liquid chromatography-tandemmass spectrometry
