2种西洛他唑制剂人体药动学比较研究  

Pharmacokinetics of 2 Preparations of Cilostazol in Human Body

作　　者：刘书铭[1] 周远大[2] 

机构地区：[1]四川乐山职业技术学院,乐山市614000 [2]重庆医科大学附属第一医院临床药理研究室,重庆市400016

出　　处：《中国药房》2006年第11期837-839,共3页China Pharmacy

摘　　要：目的：比较2种西洛他唑制剂在正常人体内药动学情况.方法：22名健康志愿受试者单剂量随机交叉口服西洛他唑胶囊或片剂100mg,采用高效液相色谱法测定血药浓度,3p97程序计算药动学参数与相对生物利用度.结果：胶囊和片剂在体内药-时曲线均符合二室模型,tmax分别为（3.10±1.09）h、（3.43±1.25）h,Cmax分别为（0.77±0.27）、（0.82±0.42）μg/ml,AUC0～t分别为（9.94±2.66）、（10.62±3.21）（μg·h）/ml.经配对t检验,2种制剂药动学参数无显著性差异（P＞0.05）,胶囊的相对生物利用度为（95.43±15.47）%.结论：2种制剂具有生物等效性.OBJECTIVE： To compare the pharmacokinetics of 2 preparations of cilostazol in healthy human body. METHODS： 22 healthy volunteers were administered with single dose of cilostazol 100mg either in capsules or tablets by randomized crossover way, the blood concentration was determined by HPLC, and the pharmacokinetics parameters and the relative bioavailability were computed by 3p97. RESULTS： The concentration- time curves of cilostazol capsules and cilostazol tablets fitted to two - compartment model. The pharmacokinetics parameters of the capsules vs. the tablets were the following ： tmax： （3.10±1.09）h vs. （3.43±1.25）h,Cmax： （0.77±0.27）vs. （0.82±0.42）μg/ml, AUCo-t： （9.94±2.66）vs. （10.62±3.21） （μg . h）/ml, no significant difference was noted between 2 preparations from the paired t test （P 〉 0.05）, the relative bioavailability of the capsules was （95.43 ± 15.47） %. CONCLUSION ： 2 preparations were bioequivalent.

关 键 词：西洛他唑 胶囊 片剂 生物利用度 药动学参数 高效液相色谱 

分 类 号：R969.1[医药卫生—药理学]