篇名 | 市售Dexamethasone錠劑之品質調查 |
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卷期 | 18 |
並列篇名 | An Investigation on the Quality of Dexamethasone Tablets in Taiwan area |
作者 | 許淑纓 、 楊明玉 、 邵清益 、 張柏林 、 溫國慶 、 廖俊亨 |
頁次 | 026-032 |
關鍵字 | Dexamethasone錠劑 、 重量差異 、 崩散度 、 鑑別 、 含量測定 、 dexamethasone tablets 、 weight variation 、 disintegration 、 identification 、 assay 、 TSCI |
出刊日期 | 200009 |
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,為暸解現階段市售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,就轄區内醫院、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,三十曰發 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.