盐酸氨溴索口腔崩解片人体生物等效性研究

Bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets in Healthy Volunteers

目的:研究单剂量口服盐酸氨溴索口腔崩解片后的血药浓度经-时过程,并进行生物等效性评价。方法:18名健康男性受试者自身交叉单剂量口服盐酸氨溴索口腔崩解片(受试制剂)与盐酸氨溴索片(参比制剂)90mg,用高效液相色谱法测定血药浓度。结果:受试制剂与参比制剂的Cmax分别为(169.58±39.43)、(170.28±43.26)ng.mL-1,tmax分别为(1.6±0.5)、(2.2±0.6)h,t1/2分别为(6.77±2.04)、(6.50±1.27)h,AUC0～24分别为(1131.26±289.36)、(1191.54±270.17)ng.h.mL-1,AUC0～∞分别为(1215.27±306.56)、(1281.44±291.51)ng.h.mL-1;受试制剂的相对生物利用度为(95.5±15.6)%。结论:2种制剂的吸收程度等效,说明本制剂具有明显的速释效果。

OBJECTIVE： To study the time - concentration curves of single dose of ambroxol hydrochloride orally integrating tablets in healthy volunteers and to evaluate its bioequivalence.METHODS： A single oral dose of 90mg ambroxol hydrochloride orally dissolving tablets and 90 mg ambroxol hydrochloride tablets were given to 18 healthy volunteers by a randomized crossover design.The concentrations of ambroxol hydrochloride in plasma were determined by HPLC.RESULTS：The main pharmacokinetic parameters of the test and references preparations of ambroxol hydrochloride were as follows： Cmax were （169.58±39.43） ng·mL^-1and （170.28±43.26） ng·mL^-1; tmax were （1.6±0.5） hand （2.2±0.6） h; t1/2were （6.77±2.04） hand（6.50±1.27） h;AUC0-24were（1131.26±289.36） ng· h·mL^-1 and （1191. 54 ± 270 .17） ng· h·mL^-1;AUC0 were （1 215.27 ± 306.56） ng · h· mL^-1 and （1 281.44±291.51） ng · h·mL ^-1 respectively .The relative bioavailability of the test preparation was （95.5 ± 15.6） %. CONCLUSION ： The result demonstrated that the two preparatioins were bioequivalent in absorption degree,suggesting the rapid release characteristics of the preparation.