摘要
目的：研究盐酸伐昔洛韦（万乃洛韦）片在正常人体内的药动学与生物利用度。方法：采用梯度洗脱反相高效液相色谱法测定１０名健康志愿受试者ｐｏ盐酸伐昔洛韦片和阿昔洛韦片后血中阿昔洛韦浓度；以３Ｐ８７药动学计算程序处理测定结果，计算药动学参数；用双单侧ｔ检验和配对ｔ检验法对主要药动学参数进行统计分析，评价二者的生物等效性。结果：二者的药时曲线可用一室模型拟合，二者的药时曲线下面积分别为２０．６９μｇ·ｍｉｎ·ｍｌ－１与８．２２μｇ·ｍｉｎ·ｍｌ－１；达峰时间分别是２．１０ｈ与２．５７ｈ；峰浓度分别是２．８８６μｇ·ｍｌ－１与１．０８６μｇ·ｍｌ－１。结论：统计分析结果表明二者为生物不等效制剂，以阿昔洛韦片为参比制剂计算出盐酸伐昔洛韦片的相对生物利用度为３６４．０４％。
OBJECTIVE:To study the pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablet.METHODS:The acyclovir concentration in plasma was assayed by HPLC method following a single oral dose of valaciclovir hydrochloride tablet and acyclovir tablet respectively given to 10 volunteers in a open randomized cross over test.RESULTS:After a single oral dose 600 mg of valaciclovir hydrochloride tablet,the c max and t max was 2.886 μg·ml -1 and 2.10 h respectively,the AUC 0→∞ was 20.69 μg·min·ml -1 .The concentration time courves after medication conformed to a one compartment open model with a first order absorption.CONCLUSION:There were significant differences between valaciclovir hydrochloride tablet and acyclovir tablet in the AUC 0→∞ ,c max and t max .The bioavailability of valaciclovir hydrochloride tablet was 364.04%.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1997年第2期100-103,共4页
Chinese Pharmaceutical Journal
关键词
盐酸伐昔洛韦片
药动力学
生物利用度
抗病毒药
valaciclovir hydrochloride tablet,acyclovir,pharmacokinetics,bioavailability
