摘要
目的观察两种阿昔洛韦片剂的人体相对生物利用度。方法9名健康志愿者随机交叉口服单剂量400mg 仙居产或丽珠产阿昔洛韦片后 ,采用HPLC法测定不同时间血药浓度 ,并计算生物利用度参数。结果仙居与丽珠产阿昔洛韦片主要生物利用度参数均值分别为 :Tp为1.6和1.7h,AUC为3.496和3.693μg/ml·h,Cmax 为1.011和0.997μg/ml,MRT为3.27和3.53h。结论经双向单侧检验法分析表明仙居与丽珠产阿昔洛韦片剂生物等效。
Aim To evaluate the relative bioavailability of two kinds of acyclovir tablets manufactured by Xian Ju or Li Zhu pharmaceutical company. Methods Nine normal volunteers were included in a two-way cross-over study design. Blood samples were taken after a single oral dose administration of acyclovir tablets of 400mg and serum acyclovir concentration was determined by HPLC. Results The mean values of bioavailability parameters for Xian Ju product were:T=1.6h, AUC=3.496 μg/ml·h, Cmax=1.011 μg/ml, MRT=3.27 h, respectively. For Li Zhu products, the parameters were:T=1.7h, AUC=3.693μg/ml·h, Cmax=0.997 μg/ml, MRT=3.53h. Conclusion The two one-sided tests showed that two kinds of acyclovir tablets were bioequivalent.
