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目的:测定国产与进口拉西地平片剂的血药浓度,进行药动学参数比较。方法:8名健康志愿者,随机交叉,单剂量口服国产和进口拉西地平片12mg,用HPLC测定不同时间的血药浓度,用MCPKP软件进行拟合处理,并计算药动学参数。结果:国产和进口片均符合开放一室模型,T_(max),C_(max),AUC_(0~-∞),Ka,K,T_(1/2K),Vd,Cl分别为1.68±0.26h和1.38±0.33h,1.41±0.58ng/ml和2.90±0.69ng/ml,10.32±1.33(μg·h)/L和12.03±2.29(μg·h)/L,2.01±0.81/h和2.06±1.19/h,0.19±0.11/h和0.40±0.10h,4.39±1.84h和1.86±0.51h,7.23±2.85L和2.71±0.65L,1.18±0.13L/h和1.04±0.20L/h.结论:药动学参数经统计学分析,两者之间的T(1/2K)、T_(max)、C_(max)、Vd有显著性差异(P<0.05),而AUC_(0~∞)和Cl无显著差异(P>0.05)。
OBJECTIVE: To determine the plasma concentration of lacridipine tablets between domestic and imported, and to compare pharmacokinetic parameters. Methods: Eight healthy volunteers were randomized crossover and single dose oral administration of lacidipine tablets 12mg. The blood plasma concentrations at different time were determined by HPLC. The pharmacokinetic parameters were calculated by MCPKP software. Results: Domestic and imported tablets were in accordance with the open one-compartment model. The values of T max, C max, AUC 0 ~ -∞, Ka, K, T 1 / 2K, Vd and Cl were 1.68 ± 0.26h and 1.38 ± 0.33h, 1.41 ± 0.58ng / ml and 2.90 ± 0.69ng / ml, 10.32 ± 1.33 (μg · h) / L and 12 respectively. 03 ± 2.29 (μg · h) /L, 2.01 ± 0.81/h and 2.06 ± 1.19 / h, 0.19 ± 0.11 / h and 0.40 ± 0.10 h , 4.39 ± 1.84h and 1.86 ± 0.51h, 7.23 ± 2.85L and 2.71 ± 0.65L, 1.18 ± 0.13L / h and 1.04 ± 0.20L / H. Conclusion: The pharmacokinetic parameters were statistically analyzed. There was a significant difference (P <0.05) between T (1 / 2K), T max, C max and Vd. ~ ∞) and Cl no significant difference (P> 0.05).