Title: Pharmacokinetics and bioequivalence of Beiminweima capsules in Chinese healthy volunteers
Abstract: Objective To study the pharmacokinetics and bioequivalence of Beiminweima capsules(test preparation) and tablets(reference preparation) in Chinese healthy volunteers. Methods Totally 20 healthy male volunteers enrolled in a randomized 2-way cross-over design. A single oral dose of 2 capsules of test preparation or 1 tablet of reference preparation was given to each volunteer. The concentration of salicylic acid was determined by HPLC. The concentrations of paracetamol, pseudoephedrine and chlorphenamine were determined by LC-MS/MS. The pharmacokinetics and bioavailability of the 2 preparations were compared and calculated by DAS Ver 2.0 software. Results The main pharmacokinetic parameters of salicylic acid test and reference formulations were as follows: Cmax was(7.31±5.21) and(7.55±4.11) μg·mL- 1, tmax was(2.65±0.96) and(2.44±0.80) h, AUC0-36 h was(41.58±26.49) and(43.35±26.11) μg·h·mL- 1, respectively. The main pharmacokinetic parameters of paracetamol test and reference formulations were as follows: Cmax was(927.60±581.63) and(934.29±547.57) ng·mL- 1, tmax was(3.2±1.8) and(2.3±0.8) h, AUC0-48 h was(6 515.39±2762.32) and(6 657.62±3133.67) ng·h·mL- 1, respectively. The main pharmacokinetic parameters of pseudoephedrine test and reference formulations were as follows: Cmax was(134.16±45.88) and(140.86±55.92) ng·mL- 1, tmaxwas(1.9±0.8) h and(1.6±0.7) h, AUC0-48 h was(1 018.09±367.80) and(1 020.17±388.85) ng·h·mL- 1, respectively. The main pharmacokinetic parameters of chlorphenamine test and reference formulations were as follows: Cmaxwas(3.64±1.52) and(3.90±1.64) ng·mL- 1, tmax was(3.0±1.8) and(3.2±2.0) h, AUC0-48h was(74.29±33.13) and (74.95±34.96) ng·h·mL- 1, respectively. The relative bioavailability of the test preparation to reference preparation were(94.18±18.60)% for salicylic acid,(101.62±22.89)% for paracetamol,(102.63±17.55)% for pseudoephedrine and(101.33±16.50)% for chlorphenamine. Conclusion The HPLC and LC-MS/MS methods prove accurate and sensitive with reliable results. There is no difference in rate and extent of absorption, distribution and elimination of salicylic acid, paracetamol, pseudoephedrine and chlorphenamine between the test and reference preparation.
Publication Year: 2014
Publication Date: 2014-01-01
Language: en
Type: article
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