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采用反相高效液相色谱法测定１１名健康志愿受试者单剂量口服７５ｍｇ和多剂量口服吲哚美辛缓释胶囊和吲哚美辛片后，吲哚美辛血药浓度变化情况。测得单剂量口服７５ｍｇ吲哚美辛缓释胶囊与吲哚美辛片的达峰时间分别是４．０ｈ与１．５ｈ，峰浓度分别是１．０２μｇ·ｍｌ－１与３．７μｇ·ｍｌ－１，吲哚美辛缓释胶囊的相对生物利用度为１０２％。测得多剂量口服吲哚美辛缓释胶囊与吲哚美辛片达稳态后的Ｃｍｉｎ分别是０．２０８μｇ·ｍｌ－１与０．２６３μｇ·ｍｌ－１，Ｃｍａｘ分别是１．２６μｇ·ｍｌ－１与１．２２６μｇ·ｍｌ－１，Ｔｍａｘ分别为２．７７ｈ与１．８２ｈ，ＦＩ分别是１４０．８１％与１２８．２１％。以ＡＵＣ为指标，经统计分析，吲哚美辛缓释胶囊与吲哚美辛片在单剂量和多剂量达稳态时是生物等效制剂。
The concentrations of indometacin in 11 healthy volunteers were determined by reverse-phase high-performance liquid chromatography after oral administration of 75 mg and multiple doses of oral indomethacin capsules and indomethacin tablets. Measured single-dose oral administration of 75mg indomethacin sustained-release capsules and indomethacin tablets peak time were 4.0h and 1.5h, peak concentrations were 1.02μg · ml-1 and 3.7μg · ml -1, the relative bioavailability of indomethacin sustained release capsules was 102%. The measured Cmin of multidose oral indomethacin sustained-release capsules and indomethacin tablets reached 0.208μg · ml-1 and 0.263μg · ml-1, respectively, and the Cmax values were 1.26μg · ml -1 and 1.226μg · ml-1 respectively, Tmax was 2.77h and 1.82h respectively, FI was 140.81% and 128.21% respectively. Taking AUC as an index, the statistical analysis showed that indometacin sustained-release capsules and indomethacin tablets were bioequivalent at steady state with single dose and multiple doses.