- 期刊
市售Metronidazole錠劑之溶離度品質調查
Evaluation on Dissolution Quality of Metronidazole Tablets from Taiwan District
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%。
並列摘要
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.
延伸閱讀
- 許清萍、陳玉盆、蘇自安、徐廷光、謝彭生（1987）。市售Nalidixic Acid錠劑之溶離度品質調查。藥物食品檢驗局調查研究年報，()，69-72。https://doi.org/10.6946/ASRNL.198709.0069
- 許淑纓、魏念慈、李鳳儀、徐廷光、莊清堯、Mei-Shien Lo（1988）。市售Acetaminophen錠劑之溶離度試驗及其品質調查。藥物食品檢驗局調查研究年報，()，43-46。https://doi.org/10.6946/ASRNL.198809.0043
- 張沅琦、徐廷光、孫慈悌（1989）。市售Indomethacin膠囊製劑之溶離度試驗及品質調查。藥物食品檢驗局調查研究年報，()，192-193。https://doi.org/10.6946/ASRNL.198909.0192
- 莊立宇（2006）。市售Metformin錠劑之品質評估〔碩士論文，高雄醫學大學〕。華藝線上圖書館。https://www.airitilibrary.com/Article/Detail?DocID=U0011-2903200614054792
- 廖婉婷、陳怡頻、黃冠崧、黃莉玲、翁淑菁、章偉浩、杜慧珍、許家銓、王博譽、曾素香、王德原（2019）。Microbial Quality Investigation of Non-sterile Pharmaceutical Products in Taiwan。食品藥物研究年報，(10)，118-127。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201912-201912310010-201912310010-118-127