论文部分内容阅读
目的:以美国MarionMerelDow.Inc.的地尔硫卓缓释胶囊(CardizemSR90mg)为对照,考察印度Torrent公司生产的定尔心缓释片(DilzemSR90mg)的相对生物利用度和药代动力学参数。方法:采用自身对照法进行单剂量和多剂量给药,血样经预处理后采用高效液相色谱法测定浓度。结果:用CRF1程序处理,定尔心缓释片的t1/2(Ka)=0.57h,t1/2(Ke)=4.01h,Tmax=2.27h,Cmax=50.61ng/ml,AUC=407.19ng·h/ml,相对生物利用度F=90.2%,多剂量给药达稳态波动系数为0.71。结论:定尔心缓释片的相对生物利用度符合《新药(西药)临床研究指导原则汇编》的要求
Objective: To the United States MarionMerelDow. Inc. Of diltiazem sustained-release capsules (Cardizem SR90mg) as a control to investigate the relative bioavailability and pharmacokinetic parameters of Dilzem SR90mg manufactured by Torrent Corporation in India. Methods: The single-dose and multi-dose administration were carried out by self-control method. The blood samples were pretreated and determined by high performance liquid chromatography. Results: With the CRF1 program, t1 / 2 (Ka) = 0.57h, t1 / 2 (Ke) = 4.01h, Tmax = 2.27h and Cmax = 50.61ng / AUC = 407.19 ng · h / ml, relative bioavailability F = 90.2%, and the multi-dose administration reached a steady-state fluctuation coefficient of 0.71. Conclusion: The relative bioavailability of Ding Er Xin sustained-release tablets conforms to the compilation of Guiding Principles of Clinical Research of New Drugs (Western Medicine)