Bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets in Healthy Volunteers
- VernacularTitle:盐酸氨溴索口腔崩解片人体生物等效性研究
- Author:
Yifu TAO
;
Ling MO
;
Dawei XIAO
;
Zheng QIAN
- Publication Type:Journal Article
- Keywords:
Ambroxol hydrochloride;
Pharmacokinetics;
Bioequivalence
- From:
China Pharmacy
1991;0(05):-
- CountryChina
- Language:Chinese
-
Abstract:
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-1 and(170.28?43.26)ng?mL-1;tmax were(1.6?0.5)h and(2.2?0.6)h;t1/2 were(6.77?2.04)h and(6.50?1.27)h;AUC0～24 were(1 131.26?289.36)ng?h?mL-1 and(1 191.54?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.
