国产和进口齐多夫定胶囊人体生物等效性评价

 目的评价国产和进口齐多夫定胶囊的人体生物等效性。方法20名健康男性志愿者随机交叉po试验制剂国产齐多夫定胶囊和参比制剂进口齐多夫定胶囊300mg,采用反相高效液相色谱法测定血浆中药物浓度。结果试验制剂和参比制剂的t_max分别为(0.62±0.08)和(0.63±0.07)h;ρ_max分别为(5.2±2.1)和(4.9±1.8)mg·L^-1;t_1/2分别为(1.75±0.19)和(1.68±0.22)h;AUC_0-8分别为(6.1±2.0)和(6.0±1.8)mg·h·L^-1;AUC_0-∞分别为(6.2±2.0)和(6.1±1.8)mg·h·L^-1。国产齐多夫定胶囊的相对生物利用度为(102±11)%。结论经统计学分析,国产齐多夫定胶囊与进口胶囊具有生物等效性。

Studies on bioequivalence of zidovudine capsule in healthy volunteers

OBJECTIVE To study the bioavailability of domestic zidovudine eapsule and imported zidovudine capsule in healthy volunteers . METHODS A single oral dose of 300 mg domestic or imported zidovudine capsule was given to 20 healthy male volunteers in a randomized crossover study. The plasma concentrations of zidovudine were determined by reversed HPLC method. RESULTS The main pharma-cokinetie parameters of the two products were as follows: t_max(0.62±0.08) and (0.63±0.07) h,ρ_max(5.2±2.1) and (4.9±1.8) mg·L_-1,t_1/2(1.75±0.19)and(1.68±0.22) h ;AUC_0-8(6.1±2.0) and (6.0±1.8)mg·h·L^-1, respectively. The relative bioavailability of domestic to imported capsule was (102±11)%. CONCLUSION Statistic analysis showed that the domestic zidovudine capsule and imported zidovudine capsule were bioequivalent.