巿售lndomethacin膠囊製劑之溶離度試驗及品質調查

SURVEY ON THE DISSOLUTION AND QUALITY OF INDOMETHACIN CAPSULES FROM MARKET

Indomethacin 係非固醇類之抗異藥物 （nonsteroidal antiinflamma tory drugs, NSAID.），已廣泛地應用在治療風濕熱，風濕性關節炎及骨關節炎等。USP21 版收載了原料與膠囊製劑，而後者並加作了溶解離度試驗。近年來，藥品之生體可用率 （Bioavilalibility） 問題，已成為國內藥界及衛生主管單位重視之主題，因此，模擬體內溶解之體外溶離度試驗 （in vitro dissolution test） 則更為必要之試驗方法。而有關國內藥品溶解度之品質調查，本局曾作過 Nalidixic Acid, prednisolone, Acetaminophen 錠劑及 piroxicam 膠囊等品目，其結果不合格率頗高，足見國內製藥界對藥品溶解溶離度之品質管制仍須加強。本報告係為了解市售膠囊製劑 Indomethacin 是否附合美國藥典21版溶離度試驗之要求，而作此溶解度之品質調查。

Forty-nine samples of Indomethacin capsules preparations purchased from market were analyzed by a dissolution method and also by a High performance Liquid Chromatographic. Method described in USPXXI. The results indicated that 95.9% of the samples' Assay met the requirements in USPXXI. However, only 65.3% of the samples passed USPXXI specifications of the results of dissolution that were also taken into consideration. The facts implied that the quality of the Indomethacin capsules in the dissolution test must be improved immediately.