论文部分内容阅读
采用随机交叉试验法,6名健康自愿受试者分别口服单次剂量的国产和进口布洛芬糖衣片0.4g。于高效液相色谱(HPLC)上测试血药浓度,微机处理数据,计算药代动力学参数,评价两制剂的生物等效性。以甲醇:水(65:35)为流动相,LichrosorbRP-8为固定相,氟吡洛芬为内标,在紫外线220nm处检测。该法快速灵敏,重现性好。结果表明,各项药代动力学参数统计学检验均无显著性差异,证实国产与进口布洛芬片剂具有生物等效性。
Using randomized crossover test, six healthy volunteers were orally given a single dose of 0.4g of homemade and imported ibuprofen sugar-coated tablets respectively. Plasma concentrations were tested on high performance liquid chromatography (HPLC), data were processed by computer, pharmacokinetic parameters were calculated, and bioequivalence of both formulations was evaluated. Methanol: water (65:35) as the mobile phase, LichrosorbRP-8 as the stationary phase, flurbiprofen internal standard, detected at UV 220nm. The method is fast and sensitive and reproducible. The results showed that the pharmacokinetic parameters of the statistical tests showed no significant difference, confirmed that domestic and imported tablets of ibuprofen bioequivalence.