【摘要】 目的研究受试药物盐酸氨溴索口腔崩解片和参比药物沐舒坦的人体生物等效性。方法19名健康男性志愿者口服单剂量受试药物或参比药物90 mg后,采用HPLC紫外法测定血浆中盐酸氨溴索浓度,用BAPP 2.0程序进行数据处理。结果参比药物沐舒坦和受试药物盐酸氨溴索口腔崩解片的ρmax分别为(168.60±46.40)和(168.34±41.16)μg.L-1,tmax分别为(2.2±0.7)和(1.6±0.5)h,t12ke分别为(6.31±1.99)和(6.21±1.75)h,AUC0→24分别为(1 115.81±342.11)和(1 171.65±372.37)μg.h.L-1。盐酸氨溴索口腔崩解片相对生物利用度为(106.2±19.6)%。结论ρmax和AUC0→24经自然对数转换后的方差分析与双单侧t检验表明,盐酸氨溴索口腔崩解片和沐舒坦吸收程度等效。tmax经非参数检验(Wilcoxon符号秩检验)表明,两者tmax有显著性差异,盐酸氨溴索口腔崩解片吸收速度明显快于沐舒坦。更多还原

【Abstract】 AIM To study the bioequivalence between test drug(ambroxol hydrochloride orally disintegrating tablets) and its reference drug(ambroxol).METHODS A single dose of 90 mg test drug and reference drug were given to 19 healthy male volunteers.HPLC method was developed to determine the concentrations of ambroxol in human plasma.The data were analyzed by the BAPP 2.0 program.RESULTS The main pharmacokinetic parameters of test drug and its reference drug were as follows:ρmax were(168.34±41.16)μg·L-1 and(168.60±46.40)μg·L-1;tmax were (1.6±0.5)h and(2.2±0.7)h.t12 were (6.21±1.75)h and(6.31±1.99)h.AUC0→24 were(1 171.65±372.37)μg·h·L-1 and(1 115.81±342.11)μg·h·L-1,respectively.The relative bioavailability of test drug was(106.2±19.6)%.CONCLUSION The results of statistical analysis for the ρmax and AUC0→24 show that the two preparations are bioequivalent.There are singnificant differences in tmax between two preparations and the ambroxol hydrochloride orally disintegrating tablets are absorbed faster.更多还原