盐酸曲马朵片的生物等效性研究

 目的对国产两种盐酸曲马朵片制剂进行生物等效性评价。方法24名健康成年男性受试者采用随机分组自身对照2×2交叉试验设计法，禁食12 h后空腹-po100 mg受试制剂或参比制剂，并采集36 h内动态血标本；用反相高效液相色谱法测定血清中药物浓度并计算相关药动学参数,判定两制剂是否生物等效。结果参比制剂和受试制剂的各主要药动学参数：t_max分别为(2.542±0.932)和(2.479±1.005) h，c_max分别为(373.595±103.258)和(384.603±110.916) μg·L^-1，AUC_0～t分别为(4766.980±1 888.807)和(4 707.511±1 749.567) μg·h·L^-1，t_1/2(ke)分别为(8.891±1.571)和(8.768±1.554) h，Ke分别为(0.081±0.017)和(0.082±0.016) h_0～t。两种制剂的主要药动学参数c_max，AUC_0～t经对数转换后进行方差分析及双单侧检验，并计算90%置信区间，表明两种制剂生物等效，相对生物利用度为(100.6±13.7)%。结论两种制剂生物等效。

Study on bioequivalence of tramadol chloride tablets

OBJECTIVE To study the bioequivalence of tramadol chloride tablets in healthy volunteers.METHODS 100 mg reference or test tramadol chloride tablets were given to 24 male healthy volunteers in a randomized two way crossover design.The drug levels in serum were assayed by RP-HPLC. RESULTS The t_max,c_max,AUC_0～t,t_1/2(ke) and Ke of the reference and test tablets were (2.542±0.932) and (2.479±1.005) h，(373.595±103.258) and (384.603±110.916) μg·L^-1，(4 766.980±1 888.807) and (4 707.511±1 749.567) μg·L^-1·h，(8.891±1.571) and (8.768±1.554) h，(0.081±0.017) and (0.082±0.016) h^-1,respectively.The mean relative bioavailability of test product vs. reference was (100.61±3.7)%.Analysis of variance and two one sided t test showed that there was no significant difference between the two formulations. CONCLUSION The two formulations were bioequivalent.