国产与进口布洛芬糖衣片生物等效性研究

Studies on Bioequivalence of Domestic and Imported Tablets of Ibuprofen

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。

A simple,sensitive and specific high performance liquid chromatography(HPLC)was used to measure the plasma concentrations of ibuprofen. Six healthy volunteers were orally given domestic and imported tablets of ibuprofen by single dose(400 mg)according to a randomized,crossover design.The bioequivalence was evaluated.Mobile phase was methanol:water(65:35)and Lichrosorb RP-8 was chromatography column. Flubiprofen was used as internal standard.The detector wavelength was 220 nm,The pharmacokinetic parameters were calculated.Statistical analysis showed no significant differences between the parameters of the two formulations,The bioequivalence of two formulations was confirmed.