摘要
目的 研究五酯胶囊对拉米夫定片的人体药动学是否具有影响,为临床合理用药提供参考。方法 12名健康受试者,男女各半,按男女分层后随机分为2组,按双周期交叉口服五酯胶囊和空白胶囊,剂量(2粒·次^-1,3次·d^-1),共服7d,并于第7d同时服拉米夫定片(100mg),洗脱期为15d。采用HPLC法测定血药浓度,计算药动学参数并进行方差分析,比较两周期的药动学参数差异。结果 健康受试者拉米夫定单次给药药动学参数:‰为(0.83±0.36)h,Cmax为(1458.2±350.4)ng·mL^-1,AUC0~16为(4310.2±911.7)ng·h·mL^-1,t1/2为(2.59±0.54)h,CL/F为(23.7±4.8)L·h^-1。合用五酯胶囊后拉米夫定的药动学参数:tmax为(0.6±0.2)h,Cmax为(1508.3±449.1)ng·mL^-1,AUC0~16为(3941.5±811.0)ng·h·mL^-1,t1/2为(2.4±0.5)h,CL/F为(25.4±5.0)L·h^-1,tmax具有显著性差异。结论 五酯胶囊能加快拉米夫定的吸收。
Objective To determine the pharrnacokinetic effect of Wuzhi capsules on lamivudine tablets, and to offer information for rational use of medicine Methods A randomized, crossover, double period study and a washout period of 15 days were carried out. The 12 volunteers each took Wuzhi capsules (2 pills) or blank capsules (2 pills) for 7 days, while on the 7th day they took lamivudine tablets (100 nag) . Plasma concentration of lamivudine was determined by HPLC-UV to calculate and compare the pharrnacokinetic parameters. Results Pharmacokinetic parameters of lamivudine were: tmax (0. 83 ± 0. 36) h, Cmax (1 458. 2±350. 4) ng . mL^-1, AUC0-16 (4 310. 2±911.7) ng . h . mL^ -1, t1/2 (2. 59±0. 54) h , and CL/F (23. 7±4. 8) L . h^-1. Pharmacokinetic parameters of lamivudine after taking Wuzhi capsules were: tmax (0. 6±0. 2) h, Cmax (1508.3±449.1) ng.mL^-1, AUC0-16 (3 941.5±811.0) ng. h. mL^-1, t1/2 (2.4±0.5) h, and CL/F (25. 4±5.0) L . h^-1. Conclusion Wuzhi capsules could speed up the absorption process of lamivudine.
出处
《中南药学》
CAS
2007年第5期461-463,共3页
Central South Pharmacy
关键词
五酯胶囊
拉米夫定
药动学
相互作用
Wuzhi capsules
lamivudine
pharmacokinelic
reaprocal effect