国产硝苯地平速释胶囊在健康人体内的药代动力学

Pharmacokinetics of domestic nifedipine immediate release capsules in healthy volunteers

目的:测定国产硝苯地平速释胶囊在人体内的药代动力学。方法:10名男性健康志愿者单剂量日服5mg国产硝苯地平速释胶囊,采用高效液相色谱（HPLC）新方法测定血浆样品药物浓度,采用3P87程序统计矩方法求算药代动力学参数。结果:国产硝苯地平速释胶囊的cmax为（52.57±10.29）ng/ml,tmax为（0.6±0.2）h,t1/2β为（2.00±0.27）h,MRT为（2.91±0.43）h,AUC0～∞为（126.81±34.03）ng·h/ml。结论:国产硝苯地平速释胶囊达峰速度快,但峰浓度高,个体差异大。

Aim:To study the pharmacokinetics of domestic nifedipine immediate release capsules (NIRC) in healthy volunteers. Methods: Ten healthy volunteers were given orally with a single dose of 5 mg NIRC. The plasma concentrations of nifedipine were determined by a new HPLC method and the data were handled with 3P87 program and the theory of statistical moment. Results:The maximum plasma concentration(cmax) of nifedipine was(52. 57±10. 29) ng/ml,the time to reach cmax (tmax) was (0. 6±0. 2) h, the elimination half-life period (t1/2b) was (2. 00±0. 27) h, the mean residence time (MRT) was (2. 91±0. 43) h, the area under time-curve (AUC) was (126. 81±34. 03) ng·h/ml, respectively. Conclusion: The tmax is quick and the cmax is relatively higher for domestic NIRC in healthy volunteers. The inter-person variation in pharmacokinetics of domestic NIRC is substantial.