摘要
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 blood concentration of domestic and foreign lacidipine tablets,and compare their pharmacokinetic parameters.METHOD:A randomized crossover study on the pharmacokinetics of lacidipine tablets at a single oral dose of 12 mg was conducted in 8 healthy volunteers.The data of plasma levels determined by HPLC were fitted with MCPKP program on computer.RESULTS:The pharmacokinetics of the two kinds of tablets were all in accord with single compartment model,and Tmax ,Cmax,AUC0~∞,Ka,K,T1/2K,Vd,Cl averaged respectively 1.68± 0. 26 h and 1. 38±0. 33 h,1. 41±0.58 ng/ml and 2. 90±0. 69 ng/ml, 10. 32±1. 33 (μg·h)/L and 12.03±2.29(μg·h)/L,2.01±0.81/hand 2.01±1.19/h,0.19±0.11/h and 0.40±0.10/h,4.39 ±1.84h and1.86±0.51h,7.23±2.85Land2.71±0.65L,1.18±0.13L/hand1.04±0.20L/h.CONCLUSION:Statistical analysis showed significant difference between domestic and foreign tablets for Tmax ,T1/2k,Cmax and Vd(P<0.05),but no significant difference between AUC0~∞and Cl(P>0. 05).
出处
《中国药学杂志》
CAS
CSCD
北大核心
1996年第5期294-296,共3页
Chinese Pharmaceutical Journal