摘要
目的 :研究尼莫地平片剂在健康人体内的药代动力学及相对生物利用度。方法 :8名健康男性志愿者随机自身交叉单剂量口服尼莫地平和尼莫通120mg后 ,采用高效液相色谱法测定血浆中尼莫地平的浓度。结果 :两药均符合口服一级吸收一房室开放模型 ,尼莫地平和尼莫通主要药动学参数 :Tmax分别为(0.90±0.28)h和(1.07±0.16)h,Cmax分别为(61.5±32.0)ng/ml和(39.7±10.1)ng/ml,AUC分别为(151.7±61.2)ng·h/ml和160.7±59.3ng·h/ml。各参数间均无显著性差异 (P>0.05)。结论 :尼莫地平对尼莫通的相对生物利用度为(93.77 %±11.62) %,经统计学分析后认为两药体内生物等效性相同。
Objective:The pharmacokinetics and relative bioavailability of oral nimodipine tablet were studied in healthy volunteers. Methods: A single 120mg oral dose of nimodipine and nimotop were given to 8 healthy male volunteers in a randomized crossover study ,the drug concentrations in plasma were determined by HPLC.Results: The plasma concentration time curves of nimodipine and nimotop were fitted to the one compartment opened model with first-order absorption. The main pharmacokinetic parameters were:Tmax (0.90±0.28)h and (1.07± 0.16) h, Cmax (61.5±32.0) ng/ml and (39.7±10.1) ng/ml, AUC (151.7±61.2) ng h/ml and(160.7±59.3)ng h/ml for nimodipine and nimotop tablets respectively. The pharmacokinetic parameters obtained from the studies showed no significant difference between the two tablets(P>0.05).Conclusion: The relative bioavailability of nimodipine tablet was (93.77%±11.62%)compared with nimotop tablet, the results of statistical analysis showed that these two drugs were biologically equivalent.
出处
《天津医科大学学报》
2002年第1期42-44,共3页
Journal of Tianjin Medical University
关键词
尼莫地平
高效液相色谱法
生物利用度
片剂
Nimodipine
High performance liquid chromatography
Bioavailability
