泛昔洛韦胶囊人体生物等效性研究

Study on bioequivalence of famciclovir capsules in human

:目的 研究泛昔洛韦胶囊在健康人体内的药代动力学与相对生物利用度 ,以评价其生物等效性。方法 采用高效液相色谱荧光检测法测定 12名健康志愿者随机交叉po单剂量 5 0 0mg泛昔洛韦胶囊与参比片后 ,血浆中代谢物喷昔洛韦药时数据经 3P97程序拟合后 ,计算其药代动力学参数。结果 泛昔洛韦胶囊与参比片的主要药代动力学参数分别为 :tmax(0 .774±0 .190 ) ,(0 .748± 0 .181)h ;cmax(4 .2 0 7± 1.0 79) ,(4 .30 3± 1.2 71)mg·L- 1 ;AUC0～∞(15 .476± 3.6 5 4) ,(14.82 8± 3 .42 0 )mg·h·L- 1 。用梯形法计算所得的AUC0～t分别为 (14.6 2 2± 3 .6 0 5 ) ,(14.0 72± 3.45 9)mg·h·L- 1 。泛昔洛韦胶囊的相对生物利用度为 (10 4.5± 10 .2 ) %。

OBJECTIVE To study the pharmacokinetics and the relative bioavailability of famciclovir capsule.METHODS 12 healthy male volunteers were enrolled.Plasma concentrations of penciclovir were determined by HPLC with fluorescence detection following administration of the oral prodrug,famciclovir.RESULTS The pharmacokinetic parameters of famciclovir capsule and tablet were as follow: t max (0.774±0.190) and (0.748±0.181) h; c max (4.207±1.079) and (4.303±1.271) mg·L -1 ; AUC 0～∞ (15.476±3.654) and (14.828±3.420) mg·h·L -1 ,and AUC 0～t (14.622±3.605) and (14.072±3.459) mg·h·L -1 ,respectively.The relative bioavailability of famciclovir capsule was (104.5±10.2)%.CONCLUSION The test capsule and reference tablet of famciclovir were bioequivalent.