摘要
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.
出处
《中国药业》
CAS
2011年第17期14-16,共3页
China Pharmaceuticals