盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度

盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度 盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度 盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度 盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度-医学论 文 作者:胡晓，张红，夏春华，陈月江【关键词】 盐酸伐昔洛韦片; 阿昔洛韦;色谱法,高压液相;药代动力学;生物利用度 Pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablets in Chinese healthy volunteers 【Abstract】 AIM: To study the pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablets and evaluate its bioequivalence. METHODS: A single oral dose 600 mg of 2 valaciclovir hydrochloride tablets was given to 18 healthy volunteers in an open randomized crossover study. The concentration of acyclovir in plasma was determined by HPLC at different time points within 14 h following administration. The pharmacokinetic parameters were calculated by BAPP 2.0 software and the bioequivalence was evaluated by two onesided t test and 90%confidence intervals. RESULTS: The calibration curve of acyclovir was linear in the range of 0.1~4.0 μg/mL and h; Cmax were and μg/mL; t1/2 were and h; AUC0-14 were 9.07?2.43 and 9.71?2.70 μg h/mL. The relative bioavailability of the test preparations compared with the reference preparations was were bioequivalent. 【Keywords】 valaciclovir hydrochloride tablet; acyclovir; chromatography, high pressure liquid; pharmacokinetics; biological availability 【摘要】 目的: 研究盐酸伐昔洛韦片在健康人体的药代动力学和相 对生物利用度，为临床合理用药提供依据. : 采用双周期、单 中心、开放、自身交叉对照的研究方法，18例健康志愿者随机分为 两组，单次,交叉口服盐酸伐昔洛韦片600 mg后，以HPLC法测定血 浆中阿昔洛韦的浓度，采用BAPP2.0软件进行数据处理，计算药代动 力学参数. 结果: HPLC法测定阿昔洛韦的线性范围为0.1~4.0 μg/mLh; Cmax分别为μg/mL. t1/2分别为h;AUC0-14分别为μg h/mL. 两种盐酸伐昔洛韦片主要药动学参数间均无显著性差异. 供试制剂对参比制剂的相对生物利用度为 %. 结论: 供试制剂和参比制剂具有生物等效性.