摘要
目的研究健康志愿者单剂口服氨溴索分散片(祛痰药)60 mg后的药代动力学及生物等效性。方法用开放随机交叉给药方案,19名男性健康志愿者分别单剂量口服氨溴索分散片(受试制剂)或氨溴索片(参比制剂)60 mg,用LC—MS／MS测定健康受试者的血药浓度,计算药代动力学参数。结果用非房室模型计算药代动力学参数,受试制剂与参比制剂的AUC0-1分别为(1215．12±476．10)和(1343．90±654．28)μg·h·L-1;AUC0-∞分别为 (1298．76±517．09)和(1448．63±725．68)μg·h·L-1;Cmax分别为(122．07 ±51．96)和(130．13±55．41)μg·L-1;tmax分别为(2．21±1．03)和(2．45± 0．74)h;t1/2分别为(9．12±1．31)和(9．27±1．15)h,氨溴索分散片的相对生物利用度为(95．02±20．62)％。结论 2种制剂具有生物等效性。
Objective To study the phannaeokineties and bioequivale - nce of ambroxol dispersible tablets in healthy male volunteers. Methods A single oral dose 60 mg ambroxol hydrocloride of test or reference formulation was given to each volunteer according to an open, randomized, cross - over study. The drug concentrations in plasma were determined by LC -MS/MS method. Results The main pharmacokinetic parameters of ambroxol hydrocloride were as follow： AUC0-1 were （1215.12±476.10） and （1343.90±54,28）μg·h·L^-1,AUC0-∞ were （1298.76± 517.09） and （1448.63 ±725.68）μg·h·L^-1,Cmax were （122.07± 51.96） and （130.13 ±55.41）μg·L^-1 ,tmax were （2.21±1.03） and （2.45±0.74） h, t1/2 were （9.12 ± 1.31 ） and （9.27±1.15 ） h for test and reference, respectively. The relative bioavailability of AUC0-t was （95.02± 20.62 ） %. Conclusion The results of statistical analysis showed that the two formulations were bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2006年第3期180-183,共4页
The Chinese Journal of Clinical Pharmacology
