Bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets
- VernacularTitle:盐酸氨溴索口腔崩解片人体生物等效性研究
- Author:
Hongyan CHEN
- Publication Type:Journal Article
- Keywords:
Ambroxol hydrochloride;
Orally disintegrating tablets;
LC-MS;
Pharmacokinetics;
Bioequivalence
- From:
China Pharmacy
2005;0(14):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the pharmacokinetic profiles and bioequivalence of test ambroxol hydrochloride vs.refe-rence preparation.METHODS:18 healthy volunteers were administered with a single oral dose of test(ambroxol hydrochloride orally disintegrating tablets)and reference ambroxol hydrochloride(60 mg)by randomized crossover way.The plasma concentrations of ambroxol hydrochloride were determined by LC-MS.The pharmacokinetic parameters and the bioavailability were computed using DAS 1.0 program.RESULTS:The main pharmacokinetic parameters of test and reference ambroxol hydrochloride were as follows:Cmax:(84.7?29.3)and(81.2?28.2)ng?mL-1;tmax:(1.7?0.5)and(1.8?0.4)h;t1/2:(7.9?0.9)and(8.3?1.0)h;AUC0～24:(638.7?180.8)and(591.4?148.3)ng?h?mL-1;AUC0～∞:(717.5?211.1)and(671.1?173.2)ng?h?mL-1,respectively.The relative bioavailability of test ambroxol hydrochloride orally disintegratiog tablets was(108.2?16.5)%.CONCLUSION:The test and reference preparations of ambroxol hydrochloride were bioequivalent.
