盐酸地尔硫(上)艹（下）卓缓释片的相对生物利用度研究

 目的：研究盐酸地尔硫(上)艹（下）卓缓释片在正常人体内的药代动力学和相对生物利用度。方法：采用HPLC测定盐酸地尔硫(上)艹（下）卓在血策中的浓度，研究8名健康志愿受试者单剂量 po 90mg被试制剂(A)和标准参比制剂(B)的体内药代动力学和相对生物 利用度，并进行统计学分析。结果：A和B的AUC_o～∞分别为(1059.6士113.5)和(1014.2士119.5)μg·h·L^-1，t_max分别为(2.7士0.4)和((2.710.1)h，c_max分别为( 102.1士13.7)和((96.3土18.6)μg·L^-1，两者的AUC_o～∞，t_max均无显著差异(P>0.05)。采用梯形法计算两者的AUC_o～∞：分别为(1025.0士74.4)和(1020.4士146.2)μg·h·L^-1，A的相对生物利用度为(101.82111.91)%。结论：两种制剂为生物等效。

Relative bioavailability of diltiazem hydrochloride sustained-release tablet

OBJECTIVE:To study the pharmacokinetics and the relative bioavailability of diltiazem hydrochloride sustained-release tablet. METHODS:The diltiazem concentrations in serum were determined by HPLC method following a single oral dose Two different brand diltiazem hydrochloride sustained-release tablets were given to 8 volunteers in a cross-over way. RESULTSThe pharmacokinetic parameters of the test tablet (TT) and the reference tablet (RT) in serum were listed as following:AUC_0～∞(1059.6±113.5) and (1014.2±119.5)μg·h·L^-1,t_max(2.7±0.4) and (2.7±0.1)h,c_max(102.1±13.7) and (96.3±18.6)μg·L^-1.There was no significant difference between the two formulations in the AUC_0～∞,t_max and c_max(P＞0.05).The relative bioavailability of TT was (101.82±11.91)%. CONCLUSION:The result of statistical analysis showed that the two sustained-release tablets are bioequivalent.