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OBJECTIVE:To study the pharmacokinetics and relative bioavailability of ibuprofen sustained release capsules in healthy volunteers for evaluating the bioequi valency .METHODS: 20 healthy volunteers took a single dose(600mg) of ibuprofen sustained release capsules and fenbid capsules(as reference drug) alternatively, then the plasma concentrations of ibuprofen were determined by HPLC.The pharmacokinetic parameters were calculated with 3p87 pharmacokinetic program and the bioequivalence was calculated .RESULTS: The pharmacokinetic parameters of ibuprofen sustained release capsule and fenbid capsule wereT1/2= (2.88+ 0.25)h, (2.91 + 0.33)h;Cmax = (30.66+ 4.21)mg/L, (29.09+3.54)mg/L;Tmax = (4.4 + 0.52)h, (4.3+0.48)h;AUCo-1, = (174.26+13.95)mg/(h . L), (165.80+ 11.89)mg/(h ?L) ;C = (16.25+ 1.47)mg/L, (15.63+1.83) mg/L; Cmin= (1.36 + 0.56) mg/L, (1.24 + 0.46) mg/ L; FI = (1.83 + 0.07), (1.84 + 0.06) .The relative bioavailability of ibuprofen sustained release capsule was( 105.10 + 7.77) % .CONCLUSION: Ibuprofen sustained release capsule and fenbid (reference drug) were bioequivalent.
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OBJECTIVE:To develop a HPLC method for determining the concentration of argine asprine in plasma MET_HODS:The analytical column was YWG C18(4 6mm?250mm,10?m) and kept analyzing at 33℃ The mobile phase consisted of a mixture of purified water-acetonitrile(96∶4,v/v)with 20?l of butylamine and 5?l of acetic acid in per 100ml mobile phase And the plasma sample was extracted with iso-propyol alcohol-chloroform(95∶5,v/v) RESULTS:The calibration curve was linear within the range of 0 97～125 0mg/L plasma concentration and the detective limit was 0 97mg/L The RSDs for inter-day and intra-day in sample of 125 0,31 25,1 95mg/L were less than 10% This method has been used for determining plasma drug concentrations in 8 healthy volunteers and the pharmacokinetic parameters of the drug were obtained CONCLUSION:The method was sensitive,accurate and stable,which is suitable for the study of bioavailibility and pharmacokinetics of argine asprine