磺胺嘧啶速释片的相对生物利用度研究

Study of Relative Bioavailability of Sulfadiazine in Healthy Volunteers

目的 研究磺胺嘧啶速释片在健康人体的相对生物利用度。 方法 8名健康受试者单剂量随机交叉口服磺胺嘧啶速释片标准参比制剂和待测制剂 10 0 0mg ,采用HPLC法测定用药后不同时间的血药浓度。结果 两种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (5 6 9 1± 94 8)mg·h·L-1和 (5 71.8± 79.1)mg·h·L-1,Cmax分别为 (2 8.5± 4 .1)mg·L-1和 (30 .1± 4 .4 )mg·L-1,Tmax分别为 (4 .5 9± 1.2 8)h和 (4 .4 8± 1.4 3)h。待测制剂的相对生物利用度为 (10 1.4± 11.4 ) %。 结论 用NDST软件对两种制剂的AUC、Cmax、Tmax等进行双向单侧t检验 。

Objective To study the relative bioavailability of sulfadiazine in healthy volunteers.Methods The plasma concentrations of sulafdiazine were determined by HPLC in 8 healthy male volunteers after an oral dose of 1000mg standard or tested formulation in crossways.Results The concentration-time curves of the two formulations were fitted to the one-compartment open model.The AUC were(569 1± 94.8) mg·h·L -1 and (571.8±79.1)mg·h·L -1 ,the C max Values were(28.5±4.1)mg·L -1 and (30.1±4.4)mg·L -1 ,the T max values were(4.59±1.28)h and (4.48±1.43)h,respectively.The relative bioavailability of the tested formulation was (101.4±11.4)%;Conclusion It is suggested that the two formulations are bioequivalent.