阿昔洛韦分散片的相对生物利用度研究

STUDY ON THE RELATIVE BIOAVAILABILITY OF ACYCLOVIR DISPERSIBLE TABLETS

目的：研究阿昔洛韦新制剂分散片与国产阿昔洛韦片的相对生物利用度。方法：１０名健康志愿者５对交叉，单剂量口服阿昔洛韦片（Ｒ）和阿昔洛韦分散片（Ｔ）２００ｍｇ，用ＨＰＬＣ法测定血清中阿昔洛韦含量，经３Ｐ８７软件处理数据。结果：Ｒ和Ｔ的Ｔｍａｘ分别为（２．１±０．８）ｈ和（１．７±０．７）ｈ；Ｃｍａｘ分别为（６４４±２１６）ｍｇ／Ｌ和（７４７±２４４）ｍｇ／Ｌ；ｔ１／２Ｋｅ分别为（２．５７±０．９５）ｈ和（２．６９±１．１５）ｈ。Ｔ较Ｒ吸收更快，差异具有统计学意义（Ｐ＜０．０５）；Ｔ的吸收滞后时间也较Ｒ明显缩短（Ｐ＜０．０５）。服用Ｒ和Ｔ后，ＡＵＣ０～１２分别为２８１７（ｍｇ·ｈ）／Ｌ和２８９４（ｍｇ·ｈ）／Ｌ。Ｔ相对于Ｒ的Ｆ为１．０３，９５％的可信限为０．９４～１．１３。结论：两制剂具有等效性。

OBJECTIVE :To study the relative bioavailability of acyclovir dispersible tablets and domestic ordinary tablets. METHODS: The crossover study was conducted in 10 healthy volunteers.Blood samples were taken after a single dose of domestic ordinary tablet or acyclovir dispersible tablet was taken and blood drug concentrations were measured by HPLC.The parameters were calculated by program 3P87. RESULTS :The major parameters Tmax ,Cmax,t1/2,and AUC012 for ordinary tablets are(2.10.8)h,(644216)mg/L,(2.570.95)h,and 2187(mgh)/L and the Tmax,Cmax,t1/2, and AUC012 for dispersible tablets are(1.70.7)h,(747244)mg/L,(2.691.15)h and 2894(mgh)/L respectively. CONCLUSIONS :The ordinary tablet and dispersible tablet are bioequivalent.