Bioavailability of Ibuprofen Sustained Release Tablets in Human Body / 中国药房

ABSTRACT

OBJECTIVE: To study the pharmacokinetics and bioavailability of Ibuprofen Sustained Release Tablets in healthy volunteers.METHODS: A total of 18 male healthy volunteers were randomly divided into two groups.They were assigned to receive Ibuprofen Sustained Release Tablets(trial preparation) and Ibuprofen Sustained Release Capsules(reference preparation) respectively.The concentrations of ibuprofen in plasma were determined by RP-HPLC.The main pharmacokinetic parameters were obtained using 3p97 program.RESULTS: The Cmax of the two preparations were(25.43?0.78) ?g?mL-1 and(26.87?0.66)?g?mL-1 respectively;tmax were(3.67?0.52) h and(3.83?0.75) h;AUC0～24 were(181.20?5.12)?g?h?mL-1 and(187.58?5.29)?g?h?mL-1;AUC0～∞ were(184.34?5.35)、(191.19?4.87)?g?h?mL-1;MRT were(6.51?0.73)h and(6.80?0.48) h,respectively.The relative bioavailability of the sustained-release tablets was 103.7%.CONCLUSION: The ibuprofen sustained release tablets have remarkable sustained release efficacy.