【摘要】 目的研究2种盐酸伐昔洛韦片的生物等效性。方法18名健康受试者单剂量交叉口服500和600 mg 2种规格的盐酸伐昔洛韦片,采用HPLC-UV检测法测定血药浓度。数据经DAS软件处理。结果盐酸伐昔洛韦供试制剂600 mg片与参比制剂500 mg片的主要药动学参数如下:AUC0→Tn分别是(11.15±2.05)、(9.82±2.09)mg.h.L-1;AUC0→∞分别为(11.80±2.24)、(10.51±2.20)mg.h.L-1;ρmax分别是(2.85±0.62)、(2.40±0.51)mg.L-1;tmax分别是(2.19±0.30)、(2.19±0.25)h;t21分别是(2.51±0.45)、(2.80±0.35)h。将两制剂主要药动学参数AUC0→Tn、AUC0→∞、ρmax经剂量校正后对数转化,作生物等效性分析,按AUC0→Tn计算,受试片的相对生物利用度为(94.30±8.62)%。tmax经非参数秩和检验,两制剂差异无统计学意义。结论2种规格的盐酸伐昔洛韦生物等效。更多还原

【Abstract】 AIM To research the pharmacokinetics,relative bioavailability and bioequivalence of two different valaciclovir hydrochloride tablets in human beings.METHODS A single oral dose of 600 mg of tested valaciclovir hydrochloride tablet and 500 mg of reference valaciclovir hydrochloride tablets were given repectively to 18 healthy male volunteers according to an open randomized crossover design.The acyclovir concentration in plasma was determined by a efficient HPLC-UV method.The data were analysed by DAS program.RESULTS AUC0→Tn of tested tablet and reference one were(11.15±2.05) mg·h·L-1 and(9.82±2.09) mg·h·L-1;AUC0→∞ were(11.80±2.24)mg·h·L-1 and(10.51±2.20)mg·h·L-1;ρmax were(2.85±0.62) mg·L-1 and(2.40±0.51) mg·L-1;tmax were(2.19±0.30) h and(2.19±0.25) h;t12 were(2.51±0.45)h and(2.80±0.35) h,respectively.After dosage adjustment,the main pharmacokinetic parameters of two products showed no statistically significant difference according to DAS results.CONCLUSION Both preparations are bioequivalent.更多还原