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采用高效液相色谱法,以萘普生为内标,对我院试制的酮洛芬缓释胶囊以8名健康志愿者进行了单剂量人体相对生物利用度试验和多剂量给药达稳态后的波动性试验。结果表明,试制的缓释胶囊具有明显的缓释药动学特征,且吸收程度与作为标准参比制剂的市售普通胶囊和进口控释胶囊相比均无显著差异,人体相对生物利用度分别为85.4%和101.9%。在多剂量给药(100mg×q12h)达稳态后,其血中药物浓度的波动性显著小于给予普通胶囊(50mg×q6h和50mg×q8h),但人体相对生物利用度仍有后者的102.3%和84.5%。
Using high performance liquid chromatography with naproxen as the internal standard, the ketoprofen sustained release capsules manufactured in our hospital were tested in eight healthy volunteers for single-dose human bioavailability and multi-dose administration to steady state After the volatility test. The results showed that the trial-made sustained-release capsules have obvious pharmacokinetic characteristics of sustained-release, and the degree of absorption compared with the standard capsules and imported controlled release capsules were not significantly different, the relative bioavailability of human body 85.4% and 101.9%. After the multi-dose administration (100mg × q12h) reached its steady state, the blood drug concentration was significantly lower than the normal capsules (50mg × q6h and 50mg × q8h), but the relative bioavailability of the human body still had the latter 102 .3% and 84.5%.