罗红霉素分散片人体相对生物利用度研究

A Study on Bioavilability of Roxithromycin Tablets and Roxithromycin Dispersive Tablets in Healthy Volunteers

１０名健康男性受试者，分别单次空腹口服国产罗红霉素分散片和国产片剂３００ｍｇ后，用不同时间血中罗红霉素的浓度绘制了血药浓度时间曲线．结果表明：两种制剂中罗红霉素的药物动力学过程均符合二室模型，Ｃｍａｘ（７０２±１７３）μｇ／ｍＬ和（６４７±１２）μｇ／ｍＬ，Ｔｍａｘ为（１０５±０３４）ｈ和（１５０±０４１）ｈ，ｔ１／２（ｋｅ）为（１５８５±２１２）ｈ和（１４０７±２０７）ｈ，ＡＵＣ０→∞为（６８７±１４３）μｇ／ｍＬ·ｈ和（６５６±１４８）μｇ／ｍＬ·ｈ．比较两种制剂动力学参数，两种制剂间罗红霉素的Ｃｍａｘ和ＡＵＣ０→∞均无显著差异，Ｐ＞００５．罗红霉素分散片的平均相对生物利用率为（１０５７±１２０３）％，根据双单侧检验可以认为两种制剂在人体内具有生物等效性．

To study the pharmacokinetics and relative bioavailability of roxithromycin tablets and roxithromycin dispersive tablets,the bioavailabilities of tablets were studied in 10 normal male volunteers.A 300 mg of roxithromycin dispersive tablet was given according to a crossover design.The concentrations in plasma were determined by microbilogical analysis.The concentrationtime curves of roxithromycin tablets and roxithromycin dispersive tablets fitted to a two compartment open model.Tmax were(105034)and(150041)h;Cmax were(702173)and(647120)g/mL;The AUC were(687143) and (656148)g/mLh respectively.The pharmacokinetics parameters obtained from our study showed no significant difference between the two products(P>005).The relative bioavailability of roxithromycin tablets to roxithromycin dispersive tablets were(10571203)%.According to the two one sided test,the two formulations were bioequivalent.