【摘要】 目的评价拉米夫定片在健康人体的生物等效性。方法健康志愿者22例,随机2×2交叉,单剂量口服受试和参比制剂拉米夫定片100 mg,洗脱期为1周。采用LC-MS/MS法测定血药浓度,并用DAS药动学软件进行参数计算及评价2种制剂的生物等效性。结果单剂量口服受试和参比制剂后,血浆中拉米夫定的主要药动学参数:ρ_max分别为（881.4±236.8）和（985.0±292.4）μg·L^-1,t_max分别为（0.989±0.323）和（1.034±0.651）h,t_1/2分别为（2.889±0.622）和（2.820±0.368）h,AUC_0→t分别为（3 435±627.7）和（3 504±506.7）μg·h·L^-1,AUC_0→∞分别为（3 529±630.9）和（3 592±519.4）μg·h·L^-1,受试制剂与参比制剂的人体相对生物利用度（F）是（98.45±13.50）%。结论拉米夫定片受试制剂与参比制剂具有生物等效性。更多还原

【Abstract】 AM To evaluate the bioequivalence of lamivudine tablets in healthy male volunteers.METHODS Twenty-two healthy volunteers in randomized 2×2 crossover study were given a single oral 100 mg dose of test or reference lamivudine tablets.The plasma concentrations were determined by LC-MS/MS,and the pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program.RESULTS The main pharmacokinetic parameters for test and reference formulations were as follows:ρ_max were（881.4 ± 236.8） and（985.0 ± 292.4）μg·L^-1,t_maxwere（0.989±0.323）and（l.034 ±0.651）h,t_1/2were（2.889 ±0.622）and（2.820 ±0.368）h,AUC_0→t.were（3 435±627.7）and（3 504 ± 506.7）μg·h·L^-1,AUC_0→∞ were（3 529 ± 630.9） and（3 592±519.4） μg·h·L^-1,respectively.The relative bioavailability of lamivudine was（98.45 ± 13.50）%.CONCLUSION The results show that the two lamivudine tablets made by two different corporations are bioequivalent.更多还原