Glyburide製劑溶離曲線之探討   全文下載

Study on Dissolution Profile of Commercial Glyburide Tablets

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Daonil Tab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 （RotatingPaddleApparatus），轉速75rpm，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 compared with those obtained from thirtyfour commercial glyburide tablets in this study. Dissolution tests were performed by using a USP XXIII 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 active ingredient 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 of Daonil and that of each investigated samples. Results indicated that 10 out of 34 case samples (29.4%) were similar in DPs to Daonil in all of three media. In the meantime, three samples (8.8%) gave similar profiles as the control in two 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 pH 5.8, but different in both media of pH 6.8 and pH 7.8. Furthermore, only one case sample gaved a completely different profile compared with that of Daonil no matter what pH of dissolution media was. Finally, statistics on the number of tested samples having similar DPs as Daonil in individual media are as follows: 13 in pH 7.8 (38.2%); 17 in pH 6.8 (50%); and 33 in pH 5.8 (97.1%). 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Daonil Tab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 （RotatingPaddleApparatus），轉速75rpm，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%）。