盐酸地尔硫缓释片的相对生物利用度研究

Relative bioavailability of diltiazem hydrochloride sustained release tablet

目的:研究盐酸地尔硫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在血浆中的浓度,研究8名健康志愿受试者单剂量po90mg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AUC0～∞分别为(1059.6±113.5)和(1014.2±119.5)μg·h·L-1,tmax分别为(2.7±0.4)和(2.7±0.1)h,cmax分别为(102.1±13.7)和(96.3±18.6)μg·L-1,两者的AUC0～∞,tmax,cmax均无显著差异(P>0.05)。采用梯形法计算两者的AUC0～t分别为(1025.0±74.4)和(1020.4±146.2)μg·h·L-1,A的相对生物利用度为(101.82±11.91)%。结论:两种制剂为生物等效。

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.RESULTS:The 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.