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本试验采用高效液相色谱法研究布洛芬缓释混悬剂在２０名健康志愿者中单次或多次给药后的药代动力学及相对生物利用度。试验结果表明单剂量时缓释混悬剂的血药浓度－时间曲线数据符合一级吸收一室模型。缓释混悬剂与对照品缓释胶囊剂的药－时曲线下面积（ＡＵＣ０－１４ｈ）分别为１１８．２１±２２．８１和１１２．０６±１７．１３ｍｇ·ｈ·Ｌ－１（Ｐ＞０．０５），峰浓度（Ｃｍａｘ）２０．８１±３．０７和２１．０６±４．２７ｍｇ·Ｌ－１（Ｐ＞０．０５），虽然缓释混悬剂的达峰时间较缓释胶囊剂提前（３．４０±０．７５ｖｓ４．６５±１．１８ｈ，Ｐ＜０．０１），但在取样末端时间点的血药浓度（如Ｃ１２ｈ与Ｃ１４ｈ）两者相比无显著性差异。其相对生物利用度Ｆ＝１０５．５％，经双向单侧Ｔ检验证实缓释混悬剂与对照品具有生物等效性。多剂量时缓释混悬剂与对照品缓释胶囊剂的ＡＵＣ０－１２ｈ分别为１２０．６６±２７．２５和１１４．８９±２８．７７ｍｇ·ｈ·Ｌ－１（Ｐ＞０．０５），Ｃｍａｘ２１．３３±４．４５和１９．９２±３．３４ｍｇ·Ｌ－１（Ｐ＞０．０５），ＤＦ为１．７６±０．３５和１．７５±０．５０（Ｐ＞０．０５），ＰＴＲ为６．８９±３．７０和６．１７±１?
In this study, the pharmacokinetics and relative bioavailability of ibuprofen sustained-release suspensions after single or multiple administrations in 20 healthy volunteers were studied by high performance liquid chromatography. The results show that single-dose sustained-release suspension of plasma concentration-time curve data in line with the first-absorption model. The drug-time-response area (AUC0-14h) of the sustained-release suspension and the reference sustained-release capsules were 118.21 ± 22.81 and 112.06 ± 17.13 mg · h · L-1, respectively (P> 0.05), peak concentrations (Cmax) 20.81 ± 3.07 and 21.06 ± 4.27 mg · L-1 (P> 0.05). Although the peak release time Capsules were advanced (3.40 ± 0.75 vs 4.65 ± 1.18 h, P <0.01), but there was no significant difference in plasma concentrations at the end of the sampling period (eg C12h vs C14h). The relative bioavailability of F = 105.5%, confirmed by two-way one-sided T test sustained release suspension and the reference bioequivalence. The AUC0-12h of multi-dose slow-release suspensions and reference slow release capsules were 120.66 ± 27.25 and 114.89 ± 28.77 mg · h · L-1, respectively (P> 0.05) Cmax 21.33 ± 4.45 and 19.92 ± 3.34 mg · L -1 (P> 0.05), DF was 1.76 ± 0.35 and 1.75 ± 0.50 (P> 0.05 ), PTR was 6.89 ± 3.70 and 6.17 ± 1?