2种洛伐他汀片人体药动学及生物等效性研究  

Studies on pharmacokinetics and relative bioavailability of two kinds of lovastain tablets

作　　者：宋欣鑫[1] 邹继红[1] 谷艳[1] 白璐[1] 赵春杰[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《药物分析杂志》2007年第10期1530-1532,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:比较2种洛伐他汀片在健康人体内的药代动力学和生物利用度,评价2种制剂的生物等效性。方法:18名男性健康志愿者随机交叉分别单剂量口服山东罗欣药业股份有限公司研制的洛伐他汀片5片(20 mg·片^(-1))或北京万生药业有限责任公司生产的洛伐他汀片5片(20 mg·片^(-1)),采用 HPLC 测定血浆中药物浓度,通过方差分析和双向单侧 t 检验比较2种制剂的 AUC_(0→24)、C_(max)、T_(max)。结果:2种制剂的 T_(max)(h)分别为2.11±0.21和2.11±0.21,C_(max)(ng·mL^(-1))为93.73±17.42和92.67±13.98,t_(1/2)(h)分别为6.75±1.33和6.50±1.09,AUC_(0→24)(ng·mL^(-1)·h^(-1))分别为480.56±55.75和478.24±69.26,AUC_(0→∞)(ng·mL^(-1)·h^(-1))分别为555.33±69.98和543.04±76.25。结论:2种洛伐他汀片生物等效,受试制剂与参比制剂的相对生物利用度为(102.67±6.98)%。Objective：To evaluate the bioequivalence of two kinds of lovastain tablets. Methods：The randomized, crossed -over study was conducted in 18 healthy volunteers. After a single dose （containing 100 mg lovastain） ,the plasma drug levels were determined by HPLC. The concentration - time curve, Cmax, Tmax, were compared by statisti- cal analysis. Results：The main pharmacokinetic parameters of test and reference preparation were as followed：tmax （h） were 2. 11 ± 0. 21 and 2. 11 ± 0. 21, Cmax （ng · mL^-1 ） were 93.73 ± 17.42 and 92. 67 ± 13.98, t1/2 （h） were 6. 75 ± 1.33and 6. 50 ± 1.09, AUC0_24 （ ng · mL^-1 . h^-1 ） were 480. 56 ± 55.75 and 478.24 ± 69. 26. AUC0→∞ （ng · mL^-1 · h^-1） were 555.33 ± 69. 98 and 543.04 ± 76. 25. Conclusion：The results show that the two formula- tions were bioequivalent. The relative bioavailability of lovastain tablets was （ 102. 67 ± 6. 98 ） %.

关 键 词：洛伐他汀 生物利用度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]