口服国产阿齐霉素胶囊生物利用度比较研究

COMPARATIVE STUDY ON THE BIOAVAILABILITY OF DOMESTIC AND FOREIGN AZITHROMYCIN CAPSULES IN HEALTHY VOLUNTEERS

健康志愿者１０名单剂空腹ｐｏ国产阿齐霉素胶囊５００ｍｇ后，其血药峰浓度为０．３９±０．２０ｍｇ／Ｌ，消除半衰期为４７．８２±１０．８０ｈ，ＡＵＣ为４．８４±１．１７ｈ·ｍｇ／Ｌ，与进口品相似，两者间差异无统计学意义（Ｐ＞０．０５）。与进口阿齐霉素胶囊相比，国产阿齐霉素胶囊的相对生物利用度为１０９．６％，口服该药后１２０ｈ尿排出率为给药量的１０．２％。

The bioavailability of domestic and foreign azithromycin was studied in 10 healthy male volunteers following a cross over design by using single oral dose.The results showed that the serum and urine level and pharmacokinetic parameters have no significant difference between the two.The C max ,t 1/2 and AUC for domestic product are 0.39±0.20 mg/L,47.82±10.80h,and 4.84±1.17 h·mg/L respectively.The relative bioavailability measured by bioassay and urine cummulative excretion of domestic product are 109.62% and 10.15% respectively.