本研究之目的在於比較國內市售Glyburide單方錠劑與德國Hoechst廠之DaonilTab 對照品溶離曲線之相似性， 每一檢體均分別以 pH7.8、6.8、5.8 之磷酸緩衝液當作溶媒，所用裝置為 USP Apparatus 2(Rotating Paddle Apparatus)， 轉速 75 rpm，測定 15、 30、 45、60、 90 及 120 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。 送樣三十四件檢體中，溶離曲線與對照品比對結果，三種 pH 均相似者有十件 (佔全數檢體的 29.4 ％ )； pH7.8、5.8 相似，但 pH6.8 時不相似者三件 (佔 8.8 ％ )； pH6.8、5.8 相似，而 pH7.8 不相似之檢體有七件 (佔 20.6 ％ )。 其次是只有 pH5.8 之溶離曲線相似，而 pH7.8、6.8 時均不相似之檢體十三件 (佔 38.2 ％ )。最後，是於三種 pH 之溶離曲線均與對照品不相似者一件 (佔 2.9 ％ )。另外，如就各不同 pH 溶媒中溶離曲線相似之件數予以統計，於 pH7.8 相似者十三件 (佔 38.2 ％ )，pH6.8 時有十七件 (佔 50 ％ )，pH5.8 則有三十三件 (佔 97.１％）。

　　　　　The dissolution profile (DP) of a glyburide containing tablet-Daonil(supplied by Hoechst, Germany and used as the reference sample) was comparedwith those obtained from thirty- four commercial glyburide tablets in thisstudy. Dissolution tests were performed by using a USP XX Ⅲ aparatus- Ⅱ(paddle type) at 75 rpm, and three buffer solutions of pH 7.8, 6.8 and 5.8,respectively, were used as the media. Released percentages of the activeingredient were meassured at 15, 30, 45, 60, 90 and 120 minutes. SUPAC*f2 factor proposed by FDA was applied to verify the similarity between the DP ofDaonil and that of each investigated samples. Results indicated that 10 out of34 case samples (29.4%) were similar in DPs to Daonil l in all of three media.In the meantime, three samples (8.8%) gave similar profiles as the control intwo media of pH 7.8 and pH 5.8 It was also found that thirteen tested samples(38.2%) were similar in DPs to Daonil in a buffer solution of pH5.8, butdifferent in both media of pH 6.8 and pH7.8. Furthermore, only one case samplegaved a completely different profile compared with that of Daonil no matter whatpH of dissolution media was. Finally, statistics on the number of tested sampleshaving similar DPs as Daonil in individual media are as follows: 13 in pH7.8(38.2%); 17 in pH6.8(50%); and 33 in pH5.8 (97.1%).