国产与进口吗氯贝胺片剂的生物等效性

Bioequivalence of moclobemide domestic and imported in human

目的:评价国产与进口吗氯贝胺的生物等效性。方法:20名健康受试者顿服300mg吗氯贝胺,采用自身交叉试验方法,以测定受试制剂的相对生物利用度,采用HPLC方法进行人血清药物浓度测定。结果:受试制剂和参比制剂的主要药动学参数t_(max)分别为(1.3±0.6),(1.3±0.7)h;c_(max)为(4096.2±1283.7),(3776.6±1241.3)mg·mL^(-1);AUC_(0→t)为(20313.3±10587.5),(1968.4±10178.6)ng·h·mL^(-1);T_(1/2)为(3.8±1.9),(3.7±1.8)h。2制剂间各参数差异均无统计学意义(P>0.05)。受试制剂相对于参比制剂的相对生物利用度为(103.8±8.8)％。结论:受试制剂与参比制剂为生物等效制剂。

ADM: To evaluate the bioequi valence of domestic and imported moclobemide tablets. METHODS: A single oral dose of 300 mg moclobemide tablet was given respectively to 20 healthy volunteers in an open randomized cross-over test for comparison of relative bioavailabiliry in human. Moclobemide plasma concentration was determined by HPLC. RESULTS: The main pharmacokinetic parameters were as follows:tmax of test preparation and reference preparation were(1.3+ 0.6)h and (1.3 + 0.7)h, Cmax were (4096.2+ 1 283.7)ng mL-1 and (3 776.6+ 1 241.3) ng mL-1, AUC0-t,were (20 313.3+10 587.5)ng h mL-1 and (19689.4+ 10 178.6) ng h mL-1, T1/2 were (3.8+ 1.9) h and (3.7+ 1.8) h, respectively. There were no statistical differences of all parameters between 2 preparations ( P > 0.05). The mean relative bioavailability of test preparation versus reference drug was (103.8 + 8.8) % . The test preparation was bioquivalent to reference preparation. CONCLUSION: The results suggest that these 2 preparations are bioequivalerit.