Bioequivalence of enteric coated tablet of Zhengqing Fengtongning.
- Author:
Si-Han ZHANG
1
;
Yuan-Da ZHOU
;
Hai-Xia HE
Author Information
- Publication Type:Journal Article
- MeSH: Animals; Biological Availability; Cross-Over Studies; Drugs, Chinese Herbal; pharmacokinetics; Female; Male; Rabbits; Random Allocation; Tablets, Enteric-Coated; Therapeutic Equivalency
- From: China Journal of Chinese Materia Medica 2008;33(6):683-685
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo explore the pharmacokinetics and bioequivalence of two kinds of enteric coated tablet of Zhengqing Fengtongning.
METHODA single dose of 45 mg kg(-1) test or reference preparation was administrated by randomized crossover way in 12 rabbits. The plasma concentrations of drug were determined by HPLC. The pharmacokinetics parameters and relative bioequivalence were calculated with 3p97 program.
RESULTThe concentration curves based on drug-time of both test and control preparations were presented by one-compartment model, tmax were (0.81 +/- 0.34), (0.60 +/- 0.30) h respectively, Cmax were (11.16 +/- 0.58), (11.90 +/- 1.44) microg mL(1) respectively, AUC(0-->t) were (61.58 +/- 6.70), (60.56 +/- 6.67) microg h mL(-1) respectively, relative bioavailability was (102.77% +/- 15.63)%. Suggesting no significant diffirence between the main pharmacokinetic parameters of two prepations.
CONCLUSIONThe two preparations are bioequivalent.
