【摘要】 目的 :研究氢溴酸右美沙芬片在健康人体的药动学及相对生物利用度。方法 :8名健康受试者单剂量随机交叉口服氢溴酸右美沙芬片参比制剂和被试制剂 6 0mg ,采用HPLC法测定用药后不同时间的血药浓度。结果 :2种制剂的体内过程均符合一房室开放模型 ,参比制剂和被试制剂的tmax分别为 (2 72± 0 2 1)h和 (2 74± 0 19)h ,cmax分别为 (5 5 1± 0 4 4) μg·L-1和(5 5 8± 0 2 7) μg·L-1,AUC分别为 (4 5 3± 2 9) μg·h·L-1和 (4 5 7± 3 0 ) μg·h·L-1,被试制剂的相对生物利用度为 (10 1±5 9) %。结论 :2种制剂具有生物等效性。更多还原

【Abstract】 AIM: To study the pharmacokinetics and relative bioavailability of dextromethorphan hydrobromide tablet in healthy volunteers. METHODS: The plasma concentrations of dextromethorphan hydrobromide were determined by high performance liquid chromatography (HPLC) in 8 healthy male volunteers after an oral dose of 60 mg standard or tested formulations in random corssways. RESULTS: The concentration-time curves of the 2 formulations were all fitted to the one-compartment open model. The t max values were (2.72±0.21) h and (2.74±0.19) h, The c max values were (5.51±0.44) μg·L -1 and (5.58±0.27) μg·L -1, the AUC were (45.3±2.9) μg·h·L -1 and (45.7±3.0) μg·h·L -1, respectively. The relative bioavailability of the tested formulation was (101±5.9)%. CONCLUSION: The 2 formulations are bioequivalent.更多还原