摘要
目的:研究国产盐酸噻氯匹定(A)和进口片(B)的药物动力学和相对生物利用度.方法:采用HPLC法测定10名健康志愿者po 500mg A和B后,盐酸噻氯匹定在血浆中的浓度,计算两者的药物动力学参数和相对生物利用度,并进行统计学分析.结果:A和B的AUC分别为(14.29±0.66)和(15.08±0.64)mg·h/L,t_(max)分别为(1.72±0.09)和(1.54±0.09)h,c_(max)分别为(1.817±0.247)和(1.998±0.199)mg/L,两者的AUC,t_(max)、C_(max)均无显著性差异(P>0.05).采用梯形法计算两者的AUC_(0-t)分别为(13.61±0.65)和(14.14±0.70)mg·h/L,A的相对生物利用度为(96.62±6.47)%.结论:国产胶囊与进口片剂具有生物等效性.
AIM: To study the pharmacokintics and relative bioavailability of domestic ticlopidine capsule. METHODS: Ten healthy volunters were given orally 500mg domestic capsule and imported tablet in randomized crossover study. The ticlopidine concentrations in serum were determined by HPLC method. RESULTS: The pharmacokinetic parameters of domestic capsule and imported tablet in serum were as follow: AUC (14. 29 ± 0. 66) and (15. 08±0. 64)mg ·h/L, t_(max) (1. 72±0.09)and (1. 54 ± 0. 09h,c_(max)(1. 817 ± 0. 247)and (1. 998±0. 199)mg/L. There were no singinfincant differences between the two preparations (P>0. 05). The realative bioavailability of domestic capsule to imported tablet was (96. 62± 6.47)%.CONCLUSTON:The result of statistical analysis shows that both preparations are bioequivalence.
出处
《中国临床药学杂志》
CAS
1998年第5期215-218,共4页
Chinese Journal of Clinical Pharmacy
