Study on Bio-Equivalence of Loratadine Syrup
- VernacularTitle:氯雷他定糖浆的人体生物等效性研究
- Author:
Hujun WANG
;
Yongge YANG
;
Yurong WANG
;
Yong LI
;
Wei MEI
- Publication Type:Journal Article
- Keywords:
Lortadine syrup;
Bio-equivalence;
HPLC
- From:
China Pharmacy
1991;0(03):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the bio-equivalence of domestic loratadine syrup and tablets in human beings.METHODS:a dose fo40mg domestic loratadine(syrup or tablet)was given to18healthy male volunteers to a randomized crossover design.Blood samples were collected before administration and20min,40min,1hr,1.5hr,2hr,3hr,4hr,6hr,8hr,12hr,24h after administration.The concentrations of Loratadine in blood were determined by HPLC.Pharmacokinetic parameters and relative bio-availability were detected with3p97program.RESULTS:The main pharmacokinetic parameters of domestic Lortadine syrup and tablet were as follows:C max were(40.91?15.42)ng/ml and(41.57?18.68)ng/ml respectively;T max were(1.04?0.19)h and(1.19?0.25)h respectively;T 1/2 were(4.43?1.67)h and(4.21?1.49)h respectively;AUC 0～24 we_ re(127.60?46.28)(ng?h)/ml and(133.13?45.65)(ng?h)/ml respectively;AUC 0～∞ were(132.98?47.43)(ng?h)/ml and(138.16?47.26)(ng?h)/ml respectively.The relative bio-availability was(96.25?21.30)%.CONCLUSION:the do?mestic Lortadine syrup and tablet are bio-equivalent.
