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10名健康者,随机交叉口服单剂量(40mg)尼卡地平普通片和缓释片后,利用HPLC法测定血浆中尼卡地平浓度,分别在1.6±0.3和3.5±0.2h达到峰值109.8±38.7和63.1±14.6μg·L-1,血药浓度曲线下面积分别为350.9±72.3和389.6±80.4μg·h·L-1。10名健康者,随机交叉口服多剂量尼卡地平普通片(每次20mg,8h一次)和尼卡地平缓释片(每次40mg,12h一次)后,测得两种片剂稳态时的Cmax分别为74.2±15.8和85.3±18.9μg·L-1,Cmin分别为9.4±2.4和12.1±2.6μg·L-1。两者的血药浓度波动系数FI分别为1.54±0.12和1.49±0.11。经双单侧T检验法检验,两种片剂血药浓度曲线下面积具有等效性。
Ten healthy subjects were randomized to receive a single dose (40mg) of nicardipine tablets and sustained release tablets. The concentrations of nicardipine in plasma were determined by HPLC. The concentrations of nicardipine in plasma were 1.6 ± 0.3 and 3.5 ± 0 .2h reached the peak 109.8 ± 38.7 and 63.1 ± 14.6μg · L-1, the area under the plasma concentration curve were 350.9 ± 72.3 and 389.6 ± 80.4μg · h · L-1.10 healthy volunteers were randomized to receive oral administration of multiple doses of nicardipine (20 mg once every 8 h) and nicardipine sustained-release tablets (40 mg each time, once every 12 h) Cmax at steady state were 74.2 ± 15.8 and 85.3 ± 18.9 μg · L-1, respectively, and Cmin were 9.4 ± 2.4 and 12.1 ± 2.6 μg · L-1, respectively. The plasma concentration fluctuation coefficients FI of the two groups were 1.54 ± 0.12 and 1.49 ± 0.11, respectively. By double unilateral T-test, the area under the plasma concentration curve of two tablets has the equivalent.