罗红霉素胶囊的药动学与生物等效性

Pharmacokinetics and bioequivalence of roxithromycin capsules in healthy volunteers

目的研究2种罗红霉素胶囊在健康志愿者体内的药动学与相对生物利用度,评价其生物等效性。方法采用双交叉、自身对照的方法,20名健康志愿者分成2组,分别单剂量口服受试胶囊和参比胶囊各300 mg,于规定时间点取血,以HPLC法测定血药浓度。结果受试胶囊和参比胶囊的ρmax分别为:(8.71±3.07)和(8.74±3.66)mg.L-1;tmax为(1.68±0.59)和(1.75±0.34)h;t12为(14.46±3.55)和(14.30±2.82)h;AUC0→t为(101.91±38.34)和(100.52±36.91)mg.h.L-1;AUC0→∞为(111.60±40.16)和(109.79±37.85)mg.h.L-1。结论方差分析及双单侧t检验表明,受试制剂与参比制剂生物等效。

AIM To study the pharmacokinetics and relative bioavailability and evaluate the bioequivalence of two roxithromycin capsules. METHODS A single oral dose of 300 mg roxithromycin of test capsule and reference one was given to 20 healthy volunteers respectively in 2 divided groups in a double cress-over, controlled study. The roxithromycin concentrations in plasma were determined by HPLC method. RESULTS The ρmax, tmax, t1/2, AUC0→t and AUC0→∞ of test roxithromycin capsule and reference one were （8.71 ± 3.07） mg·L^-1 and （8.74± 3.66） mg·L^-1, （1.68±0.59） h and （1.75±0.34） h,（14.46± 3.55）h and （14.30±2.82） h, （101.91±38.34） mg·h·L^-1 and （100.52±36.91） mg·h·L^-1, （111.60±40.16） mg·h·L^-1 and （109.79±37.85） mg·h·L^-1,respectively. CONCLUSION The results of statistical analysis show that two formulations are bioequivalent.