文章詳目資料
藥物食品檢驗局調查研究年報
加入收藏
下載文章
| 篇名 | 市售Metronidazole銳劑之溶離度品質調查 |
|---|---|
| 卷期 | 16 |
| 並列篇名 | Evaluation on Dissolution Qualityof Metronidazole Tablets from Taiwan District |
| 作者 | 許淑纓 、 楊明玉 、 邵清益 、 張柏林 |
| 頁次 | 008-013 |
| 關鍵字 | Metronidazole 、 溶離度試驗 、 含量測定 、 Dissolution 、 Assay 、 TSCI |
| 出刊日期 | 199809 |
中文摘要
為瞭解現階段市售Metronidazole錠劑之溶離度管制狀況，於民國八十五 年十二月至八十六年六月，共抽樣Metronidazole錠劑檢體15件、腸溶糖衣錠 檢體1件，參考美國藥典第XXIII版所載方法進行溶離度試驗，結果16件檢體 中，不符合藥典規定者2件，不合格率為12.5 %。若加作重量差異、崩散度及 含量測定，則不符合藥典規定者3件，不合格率為18.75%。
英文摘要
Sixteen samples of Metronidazole tablets were accumulated from local pharmaceutical factories and importers in the Taiwan district by local health authorities. These samples were analysed to understand the quality of the oral solid dosage form of domestic pharmaceutical products and the correlation of the dissolution quality with the implementation of GMP. This analysis involved four tests based on the methods specified in the United States Pharmacopoeia and Chinese Pharmacopoeia. The results showed that 12.5% of the samples were unqualified in dissolution test, 18.75% of the samples were unqualified in weight variation, 12.5% of the samples were unqualified in disintegration and 6.25% of the samples were unqualified in assay. In conclusion, it is recommended that the manufacturers should be made emphasise their manufacturing techniques, quality control systems and composition of pharmaceuticals to comply with government regulations.