论文部分内容阅读
目的:评价羟苯磺酸钙分散片与羟苯磺酸钙片的生物等效性。方法:两制剂两周期随机交叉设计,19名男性健康志愿者单剂量口服试验分散片和参比片,利用HPLC-荧光法测定血浆中羟苯磺酸钙药物浓度。结果:试验分散片和参比片的AUC0→t分别为(87.5±15.6)mg·h·L-1和(82.9±13.9)mg·h·L-1;AUC0→∞分别为(91.4±17.6)mg·h·L-1和(86.5±15.4)mg·h·L-1;Cmax(实测)分别为(10.9±3.1)mg·L-1和(10.3±2.3)mg·L-1;tmax分别为(4.0±1.1)h和(4.4±1.4)h;t1/2分别为(4.3±1.6)h和(4.7±1.4)h。羟苯磺酸钙分散片的相对生物利用度为(106.8±17.5)%。结论:统计学检验表明,试验羟苯磺酸钙分散片与参比羟苯磺酸钙片具生物等效性。
OBJECTIVE: To evaluate the bioequivalence of calcium dobesilate dispersible tablets and calcium dobesilate tablets. Methods: A randomized crossover design was conducted between the two preparations. A total of 19 male volunteers were given a single oral dose of dispersible tablets and reference tablets. The plasma concentration of calcium dobesilate was determined by HPLC-fluorescence. Results: The AUC0 → t of experimental dispersible tablet and reference tablet were (87.5 ± 15.6) mg · h · L-1 and (82.9 ± 13.9) mg · h · L-1, respectively; AUC0 → ∞ were (91.4 ± 17.6 (10.9 ± 3.1) mg · L-1 and (± 10.3 ± 2.3) mg · L-1, respectively; mg · h · L-1 and (86.5 ± 15.4) mg · h · L- tmax were (4.0 ± 1.1) h and (4.4 ± 1.4) h, respectively; t1 / 2 were (4.3 ± 1.6) h and (4.7 ± 1.4) h, respectively. The relative bioavailability of calcium dobesilate dispersible tablets was (106.8 ± 17.5)%. CONCLUSIONS: Statistical tests showed bioequivalence of calcium dobesilate dispersions with reference calcium dobesilate.