罗红霉素分散片的人体生物等效性研究  

Relative Bioavailability of Roxithromycin Dispersive Tablets in Healthy Volunteers

作　　者：黄婷[1] 李铜铃[1] 杨岚[1] 许小红[1] 郑鹏程[1] 张婷婷[1] 张洁[1] 陈束叶[1] 

机构地区：[1]四川大学华西药学院,成都610041

出　　处：《生物医学工程学杂志》2007年第2期376-378,共3页Journal of Biomedical Engineering

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。The relative bioavailability of roxithromyein 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 S00 mg roxithromyein. The experiment data were obtained using DAS programme. The values of Cmax were 10. 16±1.46 and 10.34± 1.66 μg · 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±22.49 μg · h · ml^-1 respeetively; of AUC0→∞ were 158.63±26.86 and 15S. 77±24.75 μg · h · ml^-1 for test and reference drugs. Relative bioavailability of the tested roxithromyein was 103.63% ± 14.04%. The result showed that the two dispersive tablets are bloequivalent.

关 键 词：罗红霉素 高效液相色谱 生物等效性 

分 类 号：R94[医药卫生—药剂学]