【摘要】 目的:研究盐酸伐昔洛韦片的人体相对生物利用度和生物等效性。方法:采用高效液相色谱法测定健康志愿者随机双交叉单剂量口服2种制剂的盐酸伐昔洛韦片后血浆中阿昔洛韦浓度。血浆经高氯酸沉淀蛋白,用 Zorbax SB-C₁₈（4.6 mm×150 mm,5 μm）为色谱柱,以乙腈-水-2%冰醋酸（4:86:10）为流动相,流速为1.0 mL·min^-1,检测波长为274 nm。结果:单剂量口服盐酸伐昔洛韦试验制剂和参比制剂后血浆阿昔洛韦的 C_max分别为（3.04±0.51）μg·mL^-1和（3.15±0.62）μg·mL^-1;T_max分别为（1.20±0.25）h 和（1.15±0.33）h;AUC_0～14分别为（10.71±1.94）μg·h·mL^-1和（10.36±2.37）μg·h·mL^-1;AUC_0～∞分别为（11.12±1.94）μg·h·mL^-1和（10.76±2.42）μg·h·mL^-1。试验制剂与参比制剂的人体相对生物利用度为（105.48±15.42）%。结论:2种制剂具有生物等效性。更多还原

【Abstract】 Objective:To study the relative bioavailability and bioequivalence of valacyclovir hydrochloride tablets in healthy volunteers.Metbods:A sensitive and rapid HPLC method was developed to determine the aciclovir plas- ma concentration.A single oral dose of two formulations of valacyclovir hydrochloride were given to healthy volun- teers in randomized crossover design.The plasma were precipitated by perchloric acid.The analytical column was packed with Zorbax SB-C₁₈（4.6 mm×150 mm,5 μm）.The mobile phase consisted of acetonitrile-water-2% glacial acetic acid（4:86:10）with flow rate of 1.0 mL·min^-1.The UV detection wavelength was 274 nm.Re- sults:After a single dose of valacyclovir hydrochloride of test and reference formulations,the pharmacokinetics pa- rameters for aciclovir were as follows,respectively:C_maxwere（3.04 ±0.51）μg·mL^-1and（3.15 ±0.62）μg· mL^-1;T_maxwere（1.20±0.25）h and（1.15±0.33）h;AUC_0-14were（10.71±1.94）μg·h·mL^-1and （10.36±2.37）μg·h·mL^-1;AUC_0-∞were（11.12±1.94）μg·h·mL^-1and（10.76±2.42）μg·h· mL^-1for test and reference formulations,respectively.The relative bioavailability of test formulation to reference for- mulation was（105.48±15.42）%.Conclusion:The two formulations were bioequivalence.更多还原