Title: Pharmacokinetics of diosmin tablets in healthy volunteers
Abstract: Objective:To establish an LC-MS/MS method for the determination of diosmetin(metabolite of diosmin) in human plasma,and to investigate the pharmacokinetics of diosmin tablets in healthy volunteers.Methods:In a randomized and crossover study,twenty-two male Chinese volunteers were given a single or multiple(bid for seven days) oral dose of 900 mg diosmin tablets after an overnight fast.Then,venous blood was collected at predetermined time points(0 ~ 96 h).The plasma samples separated were determined by an established LC-MS /MS method after enzyme hydrolysis with β-glucuronidase and extraction by methyl tertbutyl ether-isopropranol.The pharmacokinetic parameters of diosmetin were calculated by DAS 2.0 software.Results:The established LC-MS /MS method had a linear calibration range over 0.1 ~ 40 ng·mL- 1 with an LLOQ of 0.1 ng·mL- 1 for diosmetin in human plasma.The method validation met the criteria for bio-samples determination.The main pharmacokinetic parameters of diosmin tablets after 900 mg single or multiple oral dose were as follows:Cmax(4.2 ± 3.8) and(10.3 ±6.3) ng·mL- 1,Tmax(18.7 ±9.9) and(6.1 ±7.0) h,t1 /2(60.2 ±85.7) and(102.5 ±174.8) h,AUC0 ~ 96(185.4 ±166.2) and(277.6 ±143.8) h·ng·mL- 1,and AUC0 ~ ∞(237.2 ±170.5) and(551.0 ±606.4) h·ng·mL- 1.Conclusion:The LC-MS /MS method is proved to be specific,sensitive and accurate,and can be applied in pharmacokinetic study of diosmin tablets.
Publication Year: 2014
Publication Date: 2014-01-01
Language: en
Type: article
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