市售Dexamethasone錠劑之品質調查   全文下載

An Investigation on the Quality of Dexamethasone Tablets in Taiwan Area

Dexamethasone錠劑為具有抗炎，抗過敏及抗僂麻質斯等作用之合成皮質類固醇製劑，因其劑量甚低，品質控制不易，為瞭解現階段市售Dexamethasone錠劑之品質狀況，函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民國八十八年七月至八十八年十二月間，就轄區內醫院、藥局、藥廠及輸入代理商予以抽樣，計抽驗36件檢體，依據美國藥典所載方法進行檢驗，結果含量測定不符合規定者1件，不合格率為2.8%。本調查係本局之比較檢驗，曾於八十九年五月三十日發布新聞在案。

Thirty-six samples of dexamethasone tablets, imported or manufactured by local pharmaceutical factories in Taiwan, were collected randomly via local health authorities. These samples were analyzed to evaluate the quality. The analysis included four tests according to the methods of the United States Pharmacopoeia XX and the United States Pharmacopoeia 24. The results showed that 1 sample (2.8%) failed to meet the assay requirement of the government regulation.In conclusion, it is recommended that the manufacturers should emphasize on their manufacturing techniques, quality control systems and composition of pharmaceuticals to comply with government regulations.