罗红霉素片剂与胶囊剂人体生物利用度的比较

Study on Bioavailability of Roxithromycin Tablets and Roxithromycin Capsules in Healthy Volunteers

８名健康男性志愿者，随机交叉口服单剂量（３００ｍｇ）罗红霉素片剂与胶囊剂．用微生物检定法测定血药浓度．两种制剂的药－时曲线均符合二室模型．达峰时间Ｔｐｅａｋ分别为（１．５４±０．４１）与（１．９４±０．４４）ｈ；达峰浓度Ｃｍａｘ分别为（６．５０±０．３０）与（６．５０±０．２６）ｕ／ｍＬ；曲线下面积ＡＵＣ分别为（１２１．１４±１５．９１）与（１１４．６２±１４．０７）（ｕ／ｍＬ）·ｈ．两种制剂的药代动力学参数均无显著性差异（Ｐ＞０．０５）．罗红霉素片的相对生物利用度为：（１０５．８１±７．０６）％．

To study the pharmacokinetics and relative bioavailability of roxithromycin tablets and roxithromycin capsules the bioavailabilities of roxithromycin tablets and capsules were studied in 10 normal male volunteers.A 300 mg dosage of roxithromycin capsule was given according to a crossover design.The concentrations in plasma were determined by micro biological analysis.The concentrationtime curves of roxithromycin tablets and roxithromycin capsules fitted to a two compartment open model.Tpeak were (154±041) and (194±044) h;Cmax were (650±030) and (650±026) u/mL;The AUC were (12114±1591) and (11462±1407) u/mL·h respectively.The pharmacokinetics parameters obtained from our study showed no significant difference between the two products(P>005).The relative bioavailability of roxithromycin tablets to roxithromycin capsules were (10581±706)%.The two formulations were bioequivalent.