两种国产尼莫地平片在人体内的药动学和生物利用度

Pharmacokinetics Mechanism and Biology Utilization Rate of Two Kinds of Nimodipine in Human Body

目的 :研究两种国产尼莫地平片在人体内的药动学 ,评价其相对生物利用度和生物等效性 ,为合理用药提供依据。方法 :将 2 0名健康志愿者随机分成两组 ,交叉单剂量口服尼莫地平片A和片B各 1 2 0mg ,采用HPLC法测定血清中尼莫地平的浓度。结果 :口服尼莫地平片后 ,尼莫地平片A和片B的主要药代动力学参数分别为Cmax(96 .4 8± 2 4 .31 )ng/ml、(1 0 3.35± 2 7.5 6 )ng/ml;Tmax分别为 (0 .5 6± 0 .0 5 )h、(0 .6 4± 0 .0 7)h ;T1 / 2 分别为 (1 .80± 0 .1 7)h、(1 .6 3± 0 .1 4 )h ;AUC0 -t分别为 (1 89.5± 2 0 .7)ng .h/ml、(1 75 .6± 2 3.5 )ng .h ./ml。结论 :尼莫地平片A相对于片B的人体生物利用度为(1 0 5 .6± 8.1 ) % 。

Objective: To study on the Pharmacokinetics mechanism of two kinds of Nimodipine in human body, evaluate the biological utilization rate and biological equivalent degree, and provide basis for prescribing drugs reasonably. Methods: Divide 20 cases of health postulant into two groups by random, alternately taking type A and type B of Nimodipine 120mg single dosage orally, determine of Nimodipine in blood by HPLC. Results: The main Pharmacokinetics parameters of A and B kinds of Nimodipine are respectively(96.48±24.31)ng/ml,(103.35±27.56)ng/ml in Cmax;(0.56±0.05)h,(0.64±0.07)h in Tmax;(1.80±0.17)h,( 1.63±0.14)h inT1/( 189.5±20.7)ng.h/ml,(175.6±23.5)ng.h./ml in AUC 0-t . Conclusion: The biological utilization rate of type A relative to type B is (105.6±8.1)%.These two kinds of Nimodipine are biological equivalent. \[