盐酸氨溴索干混悬剂的人体生物等效性研究

Bioequivalence of ambroxol hydrochloride suspention

目的:研究盐酸氨溴索干混悬剂和盐酸氨溴索片的生物等效性。方法:24名健康志愿者分别单剂量口服盐酸氨溴索干混悬剂(受试制剂)和盐酸氨溴索片(参比制剂)各90 mg,采用反相高效液相色谱法测定血浆中盐酸氨溴索的浓度。采用Das 2.0程序计算其药动学参数。结果:受试制剂和参比制剂的主要药动学参数分别为:t1/2(7.968±3.212)和(7.176±3.512)h;Cmax(0.173±0.070)和(0.174±0.072)μg.mL-1;Tmax(0.969±0.450)和(0.927±0.116)h;AUC0-t(1.149±0.237)和(1.141±0.244)μg.h.mL-1。以AUC0-t计算,与参比制剂相比受试制剂中盐酸氨溴索的平均相对生物利用度为(102.0±15.1)%。结论:两种制剂具有生物等效性。

Objective：To study the pharmacokinetics and the human bioequivalence of ambroxol hydrochlo- ride suspention and ambroxol hydrochloride tablets. Methods：24 healthy volunteers were randomly administered 90 mg of ambroxol hydrochloride suspention in a single dose p.o. and ambroxol hydrochloride tablets as the control. Plasma concentrations of ambroxol hydrochloride were determined by RP-HPLC. The pharmacokinetic parameters and bioequivalence of the two preparations were analyzed using Das 2.0 program. Results ：The main pharmacokinetic parameters of the test and control drugs were as follows ：tl/2 （7. 968 ± 3. 212 ）vs. （7. 176 ± 3. 512）h; Cmax （0. 173±0.070）vs. （0. 174±0.072）μg·mL^-1 ; Tmax（0. 969 ± 0. 450）和（0. 927±0. 116）h; AUC0-1（1. 149 ± 0. 237） vs. （ 1. 141±0. 244）μg·mL^-1. The relative bioavailability of the test drug was（ 102.0 ± 15.1 ） %. Con-clusion：The test drug and reference drug were bioequivalent.