盐酸氨溴索缓释片人体生物等效性研究

Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers

目的:研究盐酸氨溴索缓释片与对照制剂的人体生物等效性。方法:20名健康受试者采用双周期2制剂自身交叉单剂量口服盐酸氨溴索缓释片和对照制剂;用高效液相色谱法测定血药浓度,3P97软件计算药动学参数和等效性分析。结果:盐酸氨溴索缓释片与对照制剂的Cmax分别为78.19±11.60和77.26±18.50 ng/ml,Tmax分别为5.00±1.16和5.00±1.16 h,AUC(0～36h)分别为1234.70±58.50和1150.10±265.48(ng/ml).h,AUC(0-inf)分别为1505.74±208.10和1381.25±364.37(ng/ml).h。Cmax,AUC(0～36h),AUC(0-in)f的90%可信区间分别为76.8%～125.6%,87.5%～109.1%,101.4%～120.3%。结论:试验制剂与对照制剂的人体相对生物利用度为(113.4±35.3)%,试验制剂与对照制剂具有生物等效性。

Objective： To study the bioequivalence of ambroxol hydrochloride sustained-release tablets to the reference. Methods ： A single oral dose （75 mg tested and reference formulation） was given to 20 healthy volunteers in a randomised crossover study.The concentrations of ambroxol hydrochloride sustained-release tablets in plasma were determined by HPLC. Results：After a single dose,the pharmaco kinetic parameters for ambroxol hydrochloride sustained-release tablets as compared with those of the reference were as follows： Cmax： （78.19±11.60）and （77.26 ±18.50） ng/ml;Tmax： （5.00 ± 1.16）and （5.00 ± 1.16）h; AUC （0-36h）： （1234.70 ± 58.50）and （1150.10 ± 265.48） （ng/ml）·h,AUG （0-inf）： （ 1505.74 ± 208.10）and（1381.25 ± 364.37）（ng/ml）·h.The 90% confidential intervals of Cmax,AUC（0-36h） and AUC （0-inf） of tested formulation were 76.8%-125.6%, 87.5%-109.1%, 101.4%-120.3%, respectively. Conclusion：The relative bioavailability is （ 113.4 ± 35.3 ）%.The results of the statistic analysis show that the two formulations are bioequivalent.