W. Ai-dong
2007
Citations
0
Influential Citations
1
Citations
Quality indicators
Journal
Chinese Journal of New Drugs
Abstract
Objective:To establish a novel HPLC-MS method for the determination of gossypol and to investigate the pharmacokinetics and bioequivalence of the compound gossypol acetic acid tablets in healthy Chinese female volunteers.Methods: A randomized two-way crossover design was conducted in 20 volunteers.Each subject was randomized to receive two kinds of compound gossypol acetic acid tablets.The plasma concentration was determined by HPLC-MS method,and the pharmacokinetic parameters of gossypol were calculated.Results: The obtained pharmacokinetic parameters of gossypol after oral administration of test and reference formulations were as follows: t1/2 were(77.9±8.9)and(79.6±7.2)h;Tmax were(5.0±1.5)and(5.6±1.3)h;Cmax were(0.79±0.40)and(0.77±0.39)μg·mL-1;AUC0~192 were(14.0±6.4)and(13.4±5.8)μg·h·mL-1,respectively.The relative bioavailability of gossypol was(104.0±15.2)%.Conclusion: The assay was sensitive,accurate and simple.The two formulations of the compound gossypol acetic acid tablets are bioequivalent.