【摘要】 目的　研究头孢克肟片与世福素胶囊的人体生物等效性。方法　采用高效液相色谱法 ,测定 2 0名健康男性单次交叉口服参比制剂及受试制剂 2 0 0mg后血清中不同时间点的药物浓度 ,计算其药物动力学参数和相对生物利用度 ,评价两制剂的生物等效性。结果　头孢克肟片和参比胶囊的AUC( 0 -t) 分别为 35 .4 6 8± 12 .86 3、33.0 98± 11.6 99mg·h·L-1,Cmax分别为 3 .6 82±1 .35 5、3. 36 4± 1.2 0 6mg·L-1,Tmax分别为 4 .5 5± 0 .83、4 .6 0± 0 .94h。结论　供试制剂相对于参比制剂的人体生物利用度为10 7.98%± 15 .76 % ,AUC( 0 t) 、Cmax对数转换后 ,经双单侧t检验并计算AUC( 0 t) 、Cmax的 90 %可信区间 ,结果表明 :两制剂具有生物等效性。更多还原

【Abstract】 OBJECTIVE To study the bioequivalence of Cefixime tablets in healthy volunteers.METHODS Cefixime concentrations in serum were determined by HPLC after single oral dose of 200 mg of Cefixime tablets or reference Cefixime tablets which were given to 20 healthy male volunteers in a randomized cross-over design.The pharmacokinetic parameters and relative bioavailability were calculated by NDST-21 program to evaluate the bioequivalence of two preparations.RESULTS AUC (0 t) of the reference and the test drug were 35.468±12.863 mg·h·L -1and 33.098±11.699 mg·h·L -1,respectively.C max of each group were 3.682±1.355 mg·L -1 and 3.364±1.206 mg·L -1,respectively. T max were 4.55±0.83 h and 4.60±0.94 h,respectively.CONCLUSION The two preparations are bioequivalent.The relative bioavailabity of the test drug was 107.98%±15.76%.更多还原