[Bioequivalence of enteric coated tablet of Zhengqing Fengtongning].
OBJECTIVE
To explore the pharmacokinetics and bioequivalence of two kinds of enteric coated tablet of Zhengqing Fengtongning.


METHODS
A 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.


RESULTS
The 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.


CONCLUSIONS
The two preparations are bioequivalent.
Zhang
Si-Han
SH
Clinical Pharmacology Laboratory, First Affiliated Hospital, Chongqing Medical University, Chongqing 400016, China. hanshi20022004@l.com
Zhou
Yuan-Da
YD
He
Hai-Xia
HX
D000818:Animals; D001682:Biological Availability; D018592:Cross-Over Studies; D004365:Drugs, Chinese Herbal / Q000493:pharmacokinetics*; D005260:Female; D008297:Male; D011817:Rabbits; D011897:Random Allocation; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency
D004365:Drugs, Chinese Herbal; D013608:Tablets, Enteric-Coated; C540317:Zhengqing Fengtongning