摘要
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.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2000年第2期117-120,共4页
Chinese Pharmaceutical Journal
关键词
地尔硫Zhou
相对生物利用度
缓释片
diltiazem,high performance liquid chromatography,relative bioavailability