Indomethacin係屬於非類固醇類之消炎鎮痛成分,具有鎮病、抗發炎作用。Indomethacin外用製劑經由皮膚之吸收性良好,能針對肌肉及關節等疼痛症狀發揮治療效果。為了解市售含Indomethacin皮膚外用軟膏、乳膏及凝膠製劑之品質狀況。委請臺北市政府衛生局、高雄市政府衛生局及部分縣市衛生局於八十八年七月至八十八年十二月間,就轄區內醫院、藥局、藥廠及輸入代理商以抽樣,計抽得46件檢體,依據日本藥局方解說書第十三版所載方法進行檢驗,結果外觀不符合規定者3件(6.5%),含量不符合規定者6件(13%),不合格産品均已函原送驗單位依相關規定處辦。
Forty-six samples of imported or domestic drugs were randomly collected via local health authorities in Taiwan area. These samples were analyzed by adopting the analysis method as described in the J. P. 13(superscript th) edition to evaluate the quality of Indomethacin External Preparations. The results showed that 6 samples failed to meet the assay requirement and among them, 3 samples failed to meet the description requirement. In conclusion, we recommend that the manufacturers to emphasize on their manufacturing techniques, quality control systems and the composition of the pharmaceuticals to comply with government regulations.