国产与进口拉西地平片剂在健康人体内的生物利用度比较

Bioavailability Comparison between Domestic Lacidipine and Imported One in Healthy Volunteers

建立了测定人血浆中拉西地平含量的反相ＨＰＬＣ方法，采用乙醚提取，ＵＶ３００ｎｍ测定。８名健康受试者单剂量交叉口服１２ｍｇ国产拉西地平片剂及进口片剂，采用上述ＨＰＬＣ法测定血浆药物浓度。结果表明，服用国产及进口片剂的血药浓度分别于（１．６８±０．２６）ｈ和（１．３８±０．３０）ｈ达到峰值（１．４１±０．５０）ｎｇ／ｍｌ和（２．９０±０．６９）ｎｇ／ｍｌ，药时曲线下面积分别为（１０．３２±１．３３）μｇ·ｈ／Ｌ和（１２．０３±２．２９）μｇ·ｈ／Ｌ国产拉西地平片剂的相对人体生物利用度Ｆ为８５．７８％。

Eight healthy volunteers crossly took orally 12mg domestic and imported lacidipine tablets with single dose and HPLC was adopted to measure drug concentration from plasma,The results showed that drug concentration from blood attained to(1.41±0.50)ng/ml and(2.90±0.69) ng/ml in peak value at(1.68±0.26)h and(1.38±0.30) h respectively.The AUC was(10.32±1.33)μg.h/L and (12.03±2.29 )μg .h/L respectively.Domestic lacidipine tablets has a relative bioavailabilitv of 85.78%.