- 期刊
Aminophylline製劑之溶離曲線比對試驗
A Comparative Study on the Dissolution Profiles of Commercial Aminophylline Tablets
摘要
本研究之目的在於探討國內Aminophylline製劑之溶離曲線，並與該製劑在全民健保用量最多之產品（對照品）的溶離曲線比較相似性，每一檢體分別以900毫升的水、0.1N HCl及pH7.4磷酸緩衝液當作溶媒，所用裝置為USP Apparatus Ⅱ (Rotating Paddle Apparatus)，轉速50rpm，測定5、10、20、30、45、60及90分鐘各時間點之溶離量，再繪製溶離曲線；並依照FDA提出的SUPAC中之f2因子，與對照品比較並判定是否相似。總計送樣十件檢體中，並無任何檢體之溶離曲線於三種溶媒中均與對照品相似；有兩件檢體以水及pH7.4磷酸緩衝液為溶媒之溶離曲線與對照品相似，但於0.1NHCl 中不相似（佔20%）；一件檢體於水中相似，另兩種溶媒中不相似（佔10%）。如果以三種溶媒中溶離曲線相似性統計，則以水為溶媒者有三件相似（佔30%），pH7.4磷酸緩衝液有兩件（佔20%），0.1N HCl 中並沒有任何檢體之溶離曲線與對照品相似。
並列摘要
Dissolution profiles (DPs) of ”U-L” aminophylline tablet, supplied by U-Liang Chem. & Pharm. Co., Ltd. Taiwan, used as the reference formulation in this study, were compared with those of ten commercial tablets. Dissolution tests were performed by employing USP XXIV apparatus-II (Paddle type) at 50 rpm. Pure water, 0.1N HCl and pH7.4 buffer were used as the dissolution media. The releasing percentages of the active ingredients were measured at 5, 10, 20, 30, 45, 60 and 90 minutes, respectively. The factor f2 of the FDA SUPAC Guide was applied to the qualitative determination on the similarity of ”U-L” aminophylline tablets dissolution profiles, and those of each investigated formulations. The results indicated that none had similar DPs comparing to those of controlled samples in all three media. 2 out of the 10 tested samples were of similar DDS (20%) to those of ”U-L” aminophylline tablets in both water and pH 7.4 buffer solution. One tested formulation showed similar in-vitro release profile to that of controlled tablets in water (10%), yet was different in both of the other two media. In summary, the number of tested samples showing similar DPs as ”U-L” aminophylline tablets in individual media were as follows: 3 in water (30%); 2 in pH 7.4 buffer solution (20%); and none in 0.1N HCl.
延伸閱讀
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