单剂量口服盐酸氨溴索缓释胶囊的人体生物等效性

目的选择12名男性健康志愿者，进行单剂量口服盐酸氨溴索缓释胶囊的人体生物等效性评价。方法采用反相高效液相色谱法，以紫外245nm为检测波长，测定了单剂量口服75mg国产盐酸氨溴索缓释胶囊受试药品和进口盐酸氨溴索缓释胶囊参比药品在健康人体内的氨溴索浓度。结果盐酸氨溴索缓释胶囊的体内动态过程呈一级吸收的二房室开放模型，国产受试药品和进口参比药品的Cmax分别为(176.5±38.9)ng.ml

Evaluation ofbioequivalence assessment after single dose ambroxol hydrochloride sustained-releasecapsules in healthy volunteers

OBJECTIVE：To evaluate the bioequivalence assessment of single dose ambroxol hydrochloride sustained-release capsules in healthy volunteers.METHODS：A reversed-phase high performance liquid chromatography (RP-HPLC) method was established for the determination of ambroxol in plasma after a single oral dose of 75 mg domestic ambroxol hydrochloride sustained-release capsules and imported ambroxol hydrochloride sustained-release capsules in a randomized crossover design.The detector was operated at UV 245 nm.RESULTS：The dynamic course of ambroxol plasma concentrations conformed to a two-compartment open model with a 3P87 program and the main pharmacokinetic parameters after a single oral dose of 75 mg domestic sustained-release capsules and imported sustained-release capsules were as follows:Cmax were (176.5±38.9)ng.ml-1 and (174.9±33.0)ng.ml-1,tmax were (3.8±0.6)h and (4.1±0.5)h,MRT were (16.2±2.8)h and (16.0±1.6)h，t1/2 were (11.4±2.7)h and (11.1±1.8)h, AUC0-36 were (1740.4±382.1)ng..ml-1 and (1738.7±326.3)ng.h.ml-1，respectively.CONCLUSIONS：The relative bioavailability of domestic ambroxol hydrochloride sustained-release capsules was (99.7±7.0)%.The results of statistical analysis for Cmax，AUC0-36 and AUC0-∞ showed that domestic sustained-release capsules and imported sustained-release capsules were bioequivalent.