【摘要】 目的 :比较2种万乃洛韦片剂 (A片和B片 )在20名男性健康志愿者中的药代动力学及生物等效性。方法 :根据交叉试验方案口服单剂量 (600mg)2种万乃洛韦片 ,采用反相高效液相色谱法测定血浆中阿昔洛韦的浓度。结果 :A、B片Tmax 分别为 (1 77±0 09)h和 (1 30±0 12)h ;Cmax 分别为 (2 55±0 16) μg/ml和 (2 96±0 21) μg/ml;AUC0～t 分别为 (9 22±0 72) μg/(h·ml)和(9 58±1 17) μg/(h·ml)。A片相对于B片的生物利用度为 (97 46±8 44) %。经配对检验与双单侧t检验 ,结果表明 ,两种片剂主要药代动力学参数Cmax、AUC0～t 的差异无显著性意义 (P>0 05)。结论 :2种万乃洛韦片为生物等效制剂更多还原

【Abstract】 OBJECTIVE:To compare the pharmacokinetics and relative bioequivalence between two products of valaciclovir tablet(tablet A,B) METHODS:Twenty healthy volunteers were orally given 600mg of either valaciclovir tablet in an open ran_domized cross-over test The valaciclovir concentration in plasma was determined by RP-HPLC method RESULTS:The peak time(Tmax) of tablets A and B were (1 77±0 09)h and (1 30±0 12)h,the peak plasmal levels(Cmax) were (2 55±0 16)μg/ml and (2 96±0 21)μg/ml,and AUCo～t were (9 22±0 72)μg/(h·ml) and (9 58±1 17)μg/(h·ml) respectively The relative bioavailability of tablet A to tablet B was (97 46±8 44)% There were no significant differences in parameters Cmax,AUCo～t between 2 products(P>0 05) CONCLUSION:The two products of valaciclovir tablet are bioequivalent更多还原