- 期刊
市售Diclofenac Sodium軟膏、凝膠、栓劑之品質調查
An Investigation for the Quality of Diclofenac Sodium Ointment, Gel and Suppositories from Taiwan District
摘要
為瞭解臺灣地區現階段市售Diclofenac Sodium軟膏、凝膠、栓劑之品質狀況，經函請北、高兩市及各縣市衛生局，於民國九十年四月至六月間，赴轄區內醫院、藥局、藥廠及輸入代理商抽驗市售檢體共計34件（包括國產28件，輸入6件，分屬18家藥廠所製造），參照原開發廠及各製造廠所制定之檢驗規格作外觀、內容量（乳膠、凝膠）、平均重量、重量差異（栓劑）、鑑別及含量測定等重點項目之檢驗。結果除「外觀檢查」不合格者1件外，其餘各項均合格，不合格率為2.94%。本調查係本局之比較檢檢，曾於九十一年二月十一日發布新聞在案。
並列摘要
In order to assess the quality of diclofenac sodium ointment、mulgel、gel and suppositories, thirty-four samples of different brand and lot numbers were purchased throughout Taiwan area from April to June 2001. The appearance, mean weight, minimum fills, identification and assay of all samples were inspected and were determined by the method described in the USP 24 and/or from the manufacturer. The results showed that all of the samples met the requirements except one sample for its appearance. The results showed that all of the samples met the requirements except one sample for its appearance.
延伸閱讀
- 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
- 許淑纓、楊明玉、邵清益、張柏林、溫國慶、廖俊亨（2000）。市售Dexamethasone錠劑之品質調查。藥物食品檢驗局調查研究年報，()，26-32。https://doi.org/10.6946/ASRNL.200009.0026
- 李鳳儀、徐廷光、孫慈悌（1989）。市售Chlorpheniramine maleate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，()，146-147。https://doi.org/10.6946/ASRNL.198909.0146
- 許淑纓、蔡式堂、邵清益（1992）。An Investigation for the Quality of Dexamethasone Tablets in Taiwan Area。藥物食品檢驗局調查研究年報，()，1-5。https://doi.org/10.6946/ASRNL.199209.0001
- 黃昱綺、呂理福、陳玉盆、黃明權（2003）。An Investigation on the Quality of Indomethacin External Preparations inTaiwan。藥物食品檢驗局調查研究年報，()，17-23。https://doi.org/10.6946/ASRNL.200309.0017