市售國產Prednisolone製劑之溶離度試驗調查報告

Evaluation on Dissolution Quality of Prednisolone Tablets from Domestic Market

許淑纓(Shu-Ying Hsu) ； 李榆澤(Yu-Tzer Li) ； 魏念慈(Nain-Stry Wei) ； 徐廷光(Ting-Guang Shyu) ； 莊清堯(Ching-Yao Chuang)

《藥物食品檢驗局調查研究年報》 6號 (1988/09) Pp. 22-25

https://doi.org/10.6946/ASRNL.198809.0022

摘要

為了解現階段國產口服固體製劑之溶離度管制狀況，曾於73年4月間由全省各縣市抽購Nalidixic Acid製劑60件，從事溶離度之測試工作，並就所得結果發表於本年報第5號，今再於73年底赴全省各縣市及台北市、高雄市抽購美國藥典及中華藥典均收載，需作溶離度試驗之Prednisolone製劑60件，依據美國藥典第廿版所載方法^1，進行檢驗。結果60件錠劑檢體中，不符合美國藥典規定者10件，其不合格率達17%。

關鍵字

Prednisolone ； 溶離度試驗 ； 含量測定 ； 分光吸光度測定法

並列摘要

In order to understand the present control status of the dissolution quality of the oral solid dosage form of domestic pharmaxeutical products. Nalidixic Acid in April, 1984 from drugstores islandwide to conduct tests and make reports accordingly. In addition we also purchased 60 samples of Prednisolone products from simialar suppliers at the end of 1984 and caned out tests based on the methods specified in The United States Pharmacopoeia. Among the samples, we found 10 samples equivalent to 17% of cases samples are not qualified. Therefore, the dissolution test at local pharmaceutical factories should be positively emphasized to promote the quality of products as soon as possible.