西洛他唑片人体生物等效性研究  

Study on bioequivalence of cilostazol table in healthy volunteers

作　　者：黄明珠[1] 申屠建中[1] 卢晓阳[1] 周惠丽[1] 陈志根[1] 史美甫[1] 

机构地区：[1]浙江大学医学院附属第一医院临床药理研究室,浙江杭州310003

出　　处：《中国药学杂志》2005年第12期926-928,共3页Chinese Pharmaceutical Journal

摘　　要：目的对国产和进口西洛他唑进行生物等效性研究。方法20例健康志愿者按标准的2×2交叉试验方案设计,分别口服参比制剂或受试制剂各200mg,并采集60h内动态血标本;采用高效液相色谱法测定血清中药物浓度,计算药动学参数,并判定两制剂是否生物等效。结果参比制剂及受试制剂中西洛他唑的主要药动学数据tmax分别为(3.350±1.137)和(3.350±1.089)h,cmax分别为(745.2±208.7)和(732.6±212.9)ng·mL-1,AUC0-1分别为(8777±2158)和(8813±2526)ng·h·mL-1,AUc0-∞分别为(9366±2038)和(9259±2595)ng·h·mL-1,t1/2(ke)分别为(14.251±6.174)和(11.864±3.447)h,Ke分别为(0.05908±0.02871)和(0.06261±0.01566)h-1;两种制剂的主要药动学参数cmax,AUC0-t经对数转换后进行方差分析及双单侧检验,并计算90%置信区间,表明两种制剂生物等效,受试制剂西洛他唑片的人体相对生物利用度为(100.52±15.52)%。结论两种制剂生物等效。OBJECTIVE: To study the bioequivalence of cilostazol tables in healthy volunteers. METHODS: 200 mg Test preparation and reference preparation were given to 20 healthy male volunteers in randomized two-way crossover design for the pharmacokinetic and relative bioavailability study. Serum concentrations of cilostazol were determined by RP-HPLC. RESULTS: The main pharmacokinetic parameters of the two preparation were: tmax(3.350 ± 1.137) and (3.350 ± 1.089)h, Cmax(745.2 ± 208.7) and (732.6 ± 212.9) ng&middotL-1, AUG0-1 (8 777 ± 2 158) and (8 813 ± 2 526)ng&middoth&middotmL-1, AUC 0-∞,(9 366 ± 2 038)and(9 259 ± 2 595)ng&middoth&middotmL-1, t1/2(Ke)(14.251 ± 6.174) and (11.864 ± 3.447)h, Ke(0.059 08 ± 0.028 71) and (0.062 61 ± 0.015 66)h-1, respectively. The mean relative bioavailability of test preparation vs reference preparation were (100.52 ± 15.52)%. CONCLUSION: The statistical analysis shows that the two preparations are bioequivlent.

关 键 词：西洛他唑 生物等效性 高效液相色谱 

分 类 号：R969[医药卫生—药理学]