米诺环素片生物等效性研究

Pharmacokinetics and relative bioavailability of minocycline hydrochloride tablets

目的：研究米诺环素片的药代动力学和相对生物利用度.方法：采用HPLC法测定20名健康男性志愿受试者随机自身交叉单剂量口服米诺环素片和米诺环素胶囊200 mg后的血药浓度,得出相应的药时曲线,计算各药代参数和相对生物利用度.结果：半衰期T1/2分别为（19.53±2.67）和（19.52±2.32）h,达峰时间Tmax分别为（1.72±0.41）和（1.72±0.70）h,峰值血浆浓度Cmax分别为（3.404±1.050）和（3.284±0.472）mg/L,药时曲线下面积AUC（0~60 h）分别为（62.50±11.77）和（56.93±7.33）（mg.h）/L.两种制剂的药动学参数差异无统计学意义（P〉0.05）,受试制剂的相对生物利用度（F）为111.5%.结论：两种制剂具有生物等效性.

AIM： To study the phamacokinetics and relative bioavailability of minocycline hydrochloride tablets. METHODS： A single oral administration （200 mg） of minocycline hydrochloride tablets was given in 20 healthy male volunteers who were divided into 2 groups according to randomized crossover design. Minocycline hydrochloride concentrations in plasma were determined by high-performance liquid chromatography （HPLC）. The pharmacokinetic parameters and relative bioavailability of tested tablets were calculated and compared with that of reference tablets. RESUILTS： After a single oral administration （200 mg） of minocycline hydrochloride and reference tablets, the obtained pharmacokinetic parameters were as follows ： T1/2 were （ 19.53 ± 2. 67 ） and （19.52±2.32） h;Tmax were（1.72 ±0.41） and （1.72 ± 0.70）h; Cmax：（3.404 ±1.050） and （3.284±0.472）mg/L; AUC（0-60h） were（62.50 ±11.77） and （56.93 ±7.33） （mg · h）/L, respectively. The relative bioavailability of tested tablets was 111.5%. No significant differences were found in the main pharmacokinetic parameters between the two kinds of tablets （P 〉 0.05 ）. CONCLUSION： The two preparations present bioequivalence.