国产与进口盐酸氨溴索片的人体生物等效性研究

Bioequivalence of Domestic and Imported Ambroxol Hydrochloride Tablets in Health Volunteers

目的评价国产与进口盐酸氨溴索片的生物等效性。 方法 9名健康男性志愿者随机交叉 ,自身对照口服单剂量国产与进口盐酸氨溴索片各 90mg后 ,进行生物等效性研究。服药间隔为 1周。采用反相高效液相色谱法测定血药浓度并用 3p87程序对试验数据进行处理。 结果国产与进口盐酸氨溴索片的AUC分别为 2 34 0 .42± 44 8.0 4和 2 36 3.5 5± 44 8.86ng·h/ml;Cmax分别为 2 11.76± 70 .71ng/ml和 2 2 6 .5 3± 34 .5 9ng/ml;tmax分别为 2 .2 2± 1.6 5和 1.82± 0 .8h ;t1/ 2ke分别为 6 .0 8± 1.0 2h和 6 .2 7± 0 .6 6h。方差分析表明两种片剂各参数之间无显著性差异 (P >0 .0 5 ) ,双单侧t检验表明二者具有生物等效性。国产片的相对生物利用度为 (99.5 6± 10 .6 5 ) % (以AUC0 -2 4 计算 )。 结论国产与进口盐酸氨溴索片具有生物等效性。

Objective To study the bioequivalence of ambroxol hydrochloride tablets. Methods A single oral administration of 90mg domestic and imported ambroxol hydrochloride tablets was given to 9 healthy male volunteers in the randomized crossover study. A high performance liquid chromatographic method was developed to determine the concentration of ambroxol hydrochloride in human plasma. The data were analyzed by the 3p87 program. Results The pharmacokinetic parameters after a single oral administration of 90mg domestic and imported tablets were as follows: AUC were 2340.42±448.04 and 2363.55±448.86ng·h/ml; C max were 211.76±70.71 and 226.53±34.59ng/ml; t max were 2.22±1.65 and 1.82±0.80h; t 1/2ke were 6.08±1.02 and 6.27±0.66h, respectively. The above parameters obtained from two formulations were compared by the analysis of variance and no significant difference was found( P >0.05). The bioequivalence of two formulations was assessed by a two one-sided test. Compared with the reference formulation, relative bioavailability of the test formulation was (99.65± 10.65)%. Conclusion The test formulation is bioequivalent with the reference.