Phenytoin製劑之溶離曲線試驗   全文下載

Study on Dissolution Profile of Commercial Phenytoin Tablets

本研究之目的在於比較國內Phenytoin錠劑與美國PARKE-DAVIS廠之Dilantin錠劑對照品溶離曲線之相似性，每一檢體均分別以(1)0.05M Tris Buffer(pH9.0)、(2)水（含1.6% Sodium Lauryl Sulfate, SLS）及(3)0.1N HCl（含0.4% SLS）當作溶媒，所用裝置為USP Apparatus II（Rotating Paddle Apparatus），轉速100rpm，測定15、30、60、90、120及180分鐘各點之溶離量，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。結果八件檢體於三種溶媒之f2值均低於50，亦即溶離曲線均與對照品不相似；比較八件檢體間之溶離情形，除了在溶媒(3)彼此之溶離曲線差異較大外，大部份檢體在溶媒(1)及(2)之溶離曲線則相類似。"

In this study, the dissolution profile (DP) of a phenytoin containing tablet-Dilantin (supplied by PARKE-DAVIS, U.S.A. and used as the reference sample) was compared with those obtained from eight brands of commercial phenytoin tablets manufactured domestically. Dissolution tests were performed by using a USP XXIII aparatus-II (paddle type) at 100 rpm, and three aqueous solutions of 0.05M Tris buffer pH 9.0 (I), 1.6% Sodium Lauryl Sulfate (SLS, II) and 0.1N HCl (containing 0.4% SLS, III), were used as test media. Released percentages of the active ingredient were measured at 15, 30, 60, 90, 120 and 180 minutes, respectively. SUPAC f2 factor proposed by FDA was applied to verify the similarity between the DP of Dilantin and that of each sample. That f2 values of samples were all less than 50 no matter which media was used indicated that all samples produced different DPs from that of Dilantin. But it can be seen that most of DPs of investigated samples are similar to each other in (I) and (II) except that in (III).