国产和进口盐酸氨溴索片的人体生物等效性研究

Study on Bioequivalence of Ambroxol Hydrochloride Tablets from Domestic and Import

目的比较国产和进口盐酸氨溴索片的人体生物等效性。方法20名健康志愿者单剂量口服国产和进口盐酸氨溴索片,采用液相色谱-串联质谱法测定血药浓度。结果单剂量口服30 mg受试制剂和参比制剂,达峰时间(tmax)分别为(1.13±0.48)h和(1.25±0.38)h,血药峰浓度(Cmax)分别为(61.2±17.7)ng/mL和(60.0±18.6)ng/mL,0～t药时曲线下面积(AUC0-t)分别为(413.3±114.4)ng.h/mL和(420.6±109.5)ng.h/mL,0-∞药时曲线下面积(AUC0-∞)分别为(436.8±122.8)ng.h/mL和(446.4±110.8)ng.h/mL,半衰期(t1/2)分别为(7.86±1.73)h和(8.12±1.18)h。结论两种盐酸氨溴索片具有生物等效性。

Objective To evaluate the bioequivalence（BE） of domestic and imported Ambroxol Hydrochloride Tablets.Methods Twenty healthy male volunteers were divided into two groups randomly and a single dosage of 30 mg of testing or reference tablet to each volunteer in the crossover way.Plasma concentratios of ambroxol were measured by LC-MS/MS.Results The pharmacokinetic of ambroxol in the testing and reference tablet were as follows：tmax were（1.13±0.48）h and（1.25±0.38）h;Cmax were（61.2±17.7）ng/mL and（60.0±18.6）ng/mL;AUC0-t were（413.3±114.4）ng·h/mL and（420.6±109.5）ng·h/mL;AUC0-∞were（436.8±122.8）ng·h/mL and（446.4±110.8）ng·h/mL;t1/2 were（7.86±1.73）h and（8.12±1.18）h respectively.Conclusion The test and reference preparations are bioequivalent.