【摘要】 目的评价国产和进口吲达帕胺缓释片(抗高血压药)在健康人体内的药代动力学与生物等效性。方法按自身对照随机交叉双周期试验设计, 20名健康志愿者单剂口服进口与国产吲达帕胺缓释片1．5 mg,用高效液相色谱-电化学检测法测定血浆中药物浓度。结果药代动力学参数如下。单剂量:Cmax分别为(19．2±6．3)和(18．1±5．6)ng·mL-1;tmax分别为 (12．3±2．1)和(12．7±1．9)h;AUC0→72分别为(528．2±264．0)和(514．5 ±210．2)ng·h·mL-1;F为(100．7±16．3)％。多剂量:Cmax分别为(34．5 ±10．7)和(36．0±11．9)ng·mL-1;Cmin分别为(16．0±5．8)和(17．2± 6．0)ng·mL-1;tmax分别为(10．7±1．8)和(10．8±2．3)h;AUCss分别为 (568．8±198．2)和(584．7±195．5)ng·h·mL-1;F为(104．2±12．5)％。结论 2种吲达帕胺缓释片具有生物等效性。更多还原

【Abstract】 Objective To evaluate the bioequivalence of domestic tablet and imported of indapamide sustained release tablet. Methods A single oral dose and multi - doses of indapamide sustained release tablet were given to 20 healthy male Chinese volunteers. The concentrations of indapamide were determined by HPLC - electrochemistry( EC) method. Results The main pharmacokinetic parameters of single dose of the two products were as follows:Cmax were (19.2 ±6. 3) and (18. 1 ±5. 6) ng · mL-1,tmax were (12. 3 ±2. 1) and (12. 7 ± 1.9) h, AUC0-72 were (528.2 ±264.0) and (514.5 ±210.2) ng · h · mL-1 for reference and test respectively. The relative bioavailablity was (100. 7 ± 16. 3)%. And the parameters of multi - doses were as follows; tmax were (10. 7 ± 1.8) and (10.8±2.3) h, Cmax were (34. 5 ±10. 7) and (36.0 ±11. 9) ng · mL-1,Cmax were (16.0±5.8) and (17.2±6.0) ng · mL-1, AUCSS were (568. 8 ± 198. 2) and (584. 7 ± 195. 5) ng · h · mL-1 ,F was (104. 2 ±12. 5)% . Conclusion The indapamide sustained release tablet of domestic and imported were bioequivalent .更多还原