盐酸格拉司琼分散片生物等效性评价  

Evaluation of bioequivalence of granisetron HCl dispersible tablet

作　　者：熊玉卿[1] 傅颖君[1] 傅军[1] 姜敏[1] 戴群[1] 

机构地区：[1]江西医学院临床药理研究所,南昌330006

出　　处：《中国新药杂志》2000年第7期468-470,共3页Chinese Journal of New Drugs

摘　　要：目的 :进行盐酸格拉司琼分散片的药代动力学研究 ,并与国产盐酸格拉司琼片进行生物利用度的比较。方法 :12名健康男性志愿者采用交叉给药方案 ,分别单剂量口服 2mg供试品或对照品后 ,用高效液相色谱荧光法测定血浆药物浓度。结果 :健康志愿者单剂量口服盐酸格拉司琼分散片后体内过程符合开放式血管外一室模型 ,其Cmax为 (7.2 4± 0 .86 ) μg/L ,t1/ 2 β为 (5 .6 0± 0 .72 )h ,Tmax为 (1.71± 0 .2 6 )h ,AUC0～ 2 4 为 (5 9.5 6± 9.84) μg·h/L ,与对照品的主要药代动力学参数比较 ,无显著性差异 (P >0 .0 5 )。供试品相对于对照品的生物利用度为 (10 1.6 8±12 .35 ) %。结论 :两制剂体内过程相仿 。Objective: To study the pharmacokinetics and relative bioquivalence of granisetron HCl tablet and dispersible tablet. Methods: 12 healthy volunteers were treated with a single oral dose of domestic granisetron HCl dispersible tablet or tablet (control)in a randomized crossover study, and their plasma drug concentration were determined by HPLC. Results: The plasma concentration time curve was fitted to one compartment model. The pharmacokinetic parameters obtained were: C max =(7.24±0.86)μg/L,t 1/2 β=(5.60±0.72)h,T max =(1.71±0.26)h,AUC 0～24 = (59.56 ±9.84) μg·h/L ,without significant difference between the active and control groups. The relative bioavailability obtained was (101.68±12.35)%. Conclusion:The pharmacokinetic profile for the 2 tablets was sim ilar so it may be concluded that they are bioequivalent.

关 键 词：盐酸格拉司琼 高效液相色谱法 药代动力学 

分 类 号：R969.4[医药卫生—药理学]