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本文比较了吲哚美辛(消炎痛)缓释胶囊和一种普通胶囊在体外的溶出速率以及在人体内生物利用度。吲哚美辛血清浓度用高效液相色谱(HPLC)测定。结果表明,2种胶囊制剂的溶出速率显著不同。在8名受试者中,2种胶囊的吸收程度基本一致;但缓释胶囊的峰药浓度(C_(max))显著低于普通胶囊(P<0.01),其达峰时间(T_(max))也明显延迟(P<0.01)。给予单剂量(50mg)缓释胶囊后,在给药后h4至h12,其血清浓度显著高于普通胶囊(P<0.05)。提示该缓释剂可避免普通制剂初期的高峰药浓度,可延长给药间隔时间。
This article compared the dissolution rate of indomethacin (indomethacin) sustained-release capsules and an ordinary capsule in vitro and the bioavailability in humans. Indomethacin serum concentrations were determined by high performance liquid chromatography (HPLC). The results show that the dissolution rates of the two capsule formulations are significantly different. However, the peak drug concentration (C_ (max)) of sustained release capsules was significantly lower than that of ordinary capsules (P <0.01), and the peak time (T_ (max) )) Was also significantly delayed (P <0.01). After giving a single dose (50mg) of sustained-release capsules, the serum concentration was significantly higher than that of ordinary capsules (P <0.05) at h4 to h12 after administration. It is suggested that the sustained-release agent can avoid the peak drug concentration in the initial period of ordinary preparation and prolong the interval between administrations.