2种盐酸氨溴索制剂的人体药动学研究

目的:比较盐酸氨溴索分散片与盐酸氨溴索普通片在健康人体内的药动学差异。方法:12名男性健康志愿者均分为2组,分别单剂量口服盐酸氨溴索分散片与盐酸氨溴索普通片各90mg,采用高效液相色谱法检测盐酸氨溴索的血药浓度,并用DAS2.1软件进行数据处理。结果:盐酸氨溴索分散片与盐酸氨溴索普通片主要药动学参数分别为:cma(x697.8±78.4)、(564.3±63.9)μg·L-1,tma(x2.9±0.2)、(4.7±0.6)h,t1/(24.8±0.7)、(5.8±0.9)h,AUC0～∞(5795.6±184.7)、(4516.4±114.9)μg·h·L-1,AUC0～24h(4643.8±107.6)、(3717.5±87.6)μg·h·L-1。结论:盐酸氨溴索分散片tmax、t1/2小于普通片,AUC0～t、AUC0～∞、cmax高于普通片,说明盐酸氨溴索分散片具有良好的速释效果。

Pharmacokinetics Study of 2 Kinds of Ambroxol Hydrochloride Preparations in Healthy Volunteers

OBJECTIVE： To compare the pharmacokinetics of Ambroxol hydrochloride dispersible tablets and Ambroxol hydrochloride tablets in healthy volunteers. METHODS： 12 healthy male volunteers were divided into two groups, who received a single oral dose of 90 mg Ambroxol hydrochloride dispersible tablets and Ambroxol hydrochloride tablets respectively. The blood concentrations of ambroxol hydrochloride were determined by HPLC, and the data was analyzed using DAS 2.1 software. RESULTS： The main pharmacokinetic parameters of Ambroxol hydrochloride dispersible tablets and Ambroxol hydrochloride tablets were as follows： Cmax were （697.8±78.4） μg·L and （564.3±63.9） μg·L^-l,tmax were（2.9±0.2）h and （4.7±0.6）h, t1//2 were （4.8±0.7） h and （5.8± 0.9）h,AUC0-∞were （5 795.6± 184.7） μg·h·L^-1 and （4 516.4±114.9） μg·h·L^-1, AUC0-24h were （4 643.8± 107.6） μg·h·L^-1 and （3 717.5 ± 87.6） μg·h·L^-1 respectively. CONCLUSION： The tmax and t1/2 ofAmbroxol hydrochloride dispersible tablets are significantly smaller than those of Ambroxol hydrochloride tablets, AUC0-t, AUC0-∞ and Cmax are significantly higher than those of Ambroxol hydrochloride tablets. It suggests that Ambroxol hydrochloride dispersible tablets have a property of swift releasing.