【摘要】 研究两种罗红霉素分散片的人体生物等效性。采用高效液相色谱(HPLC)电化学检测法测定20名健康男性受试者单剂量口服罗红霉素分散片受试制剂和参比制剂后,体内罗红霉素的血药浓度,用DAS药动学程序处理试验数据,并对试验结果进行统计分析。罗红霉素受试制剂和参比制剂的峰浓度(Cmax)分别是10．16±1．46、10．34±1．66μg·ml-1;达峰时间(tmax)分别是2．33±0．61、2．28±0．62 h;药时曲线下面积(AUC0→Tn)分别为143．32±25．80、138．93±22．49μg·h·ml-1,AUC0→∞分别为158．63±26．86、153．77±24．75μg·h·ml-1;半衰期(t1／2)分别是:9．00±1．58、8．68±1．66 h。按罗红霉素血药浓度计算,相对生物利用度为103．63％±14．04％,经统计分析两制剂药动学参数均无显著性差异,表明受试制剂和参比制剂生物等效。更多还原

【Abstract】 The relative bioavailability of roxithromycin dispersive tablet in healthy volunteers was evaluated in this study. Its concentration in plasma was detected by high performance liquid chromatography (HPLC) after twenty healthy male volunteers were given each a single dose of 300 mg roxithromycin. The experiment data were obtained using DAS programme. The values of Cmax were 10. 16±1. 46 and 10. 34±1. 66μg·ml-1 at 2. 33±0. 61 and 2. 28±0. 62 h respectively; of t1/2 were 9. 00±1. 58 and 8.68±1. 66 h respectively; of AUC0→Tn were 143. 32±25. 80 and 138. 93±22. 49μg·h·ml-1 respectively;of AUC0→∞were 158. 63±26. 86 and 153. 77±24. 75μg·h·ml-1 for test and reference drugs. Relative bioavailability of the tested roxithromycin was 103. 63%±14. 04%. The result showed that the two dispersive tablets are bioequivalent.更多还原