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选择６名男性健康志愿受试者，口服给予多剂量吲哚美辛控释胶囊，并测定了给药达稳态后的血药浓度。与普通胶囊比较，控释胶囊７５ｍｇ／次，ｑｄ给药，稳态时血浓波动性明显比普通胶囊２５ｍｇ／次，ｔｉｄ的血浓波动性小，峰谷比为：控释胶囊２．６９～～２．９３，普通胶囊６．５５～１０．２４。控释胶囊的峰、谷浓度均在有效血浓范围之内，说明每日给药１次，即可维持２４ｈ药效。用ＦＤＡ低温考察法、光照和加热稳定性试验考察了控释胶囊的稳定性。结果表明，其稳定性良好，使用期限可达２年以上。
Six male volunteers were enrolled in this study. Multiple doses of indometacin controlled release capsules were orally administered. The plasma concentrations of the drug were determined after administration. Compared with ordinary capsules, controlled release capsules 75mg / times, qd administration, steady-state blood concentration was significantly higher than the average capsule 25mg / times, tid blood concentration was small, peak to valley ratio: controlled release capsules 2.69 ~ ~ 2.93, ordinary capsules 6.55 ~ 10.24. Controlled-release capsules peak and valley concentrations are within the effective blood concentration range, indicating that once daily administration, to maintain 24h efficacy. The stability of the controlled release capsules was investigated by the FDA low temperature investigation method, light and heating stability test. The results show that its stability is good, the use of up to 2 years.