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本文对8名健康志愿者自身交叉单次服硝苯啶控释片(20mg)及普通片(20mg)进行药代动力学测定。按Tmax分别为4h及1.5h左右为峰值。另6名健康志愿者连续交叉服硝苯啶控释片20mg Bid×6天及硝苯啶普通片15mg-10mg-15mg×6天,分别在连服第1、4、5、6天早上服药前及4h及1.5h测定血药浓度,结果提示两种不同的剂型具有生物等效度。此外,对6例高血压患者多次服硝苯啶控释片(20mg Bid×6天),分别在第1、4、5、6天测早上服药前及4h时血药浓度及血压,发现虽然硝苯啶降压治疗血浓度个体差别很大,但高血压病患者服药后血药浓度上升与血压下降的变化是一致的,提示临床降压治疗中监测血压的改变可替代药代动力学测定。
In this study, 8 healthy volunteers were randomized crossover single oral administration of nifedipine (20mg) and ordinary tablets (20mg) for pharmacokinetic determination. Press Tmax respectively 4h and 1.5h for the peak. Another six healthy volunteers continuous crossover with nifedipine controlled release tablets 20mg Bid × 6 days and nifedipine ordinary tablets 15mg-10mg-15mg × 6 days, respectively, in the first service on the first day, 1,4,5,6 morning medication Before and 4h and 1.5h determination of plasma concentrations, the results suggest that two different formulations have bioequivalence. In addition, nifedipine controlled release tablets (20 mg Bid × 6 days) were administered to 6 patients with hypertension for several times. Blood concentrations and blood pressure were measured before the morning and at 4 h on days 1, 4, 5 and 6 respectively. Although nifedipine antihypertensive treatment of blood concentration varies widely among individuals, but hypertensive patients after taking medicine blood concentration and blood pressure changes are consistent, suggesting that the clinical antihypertensive treatment of blood pressure monitoring can replace the pharmacokinetics Determination.