【摘要】：目的:研究布洛芬滴丸的成型工藝并測定其體外溶出度。方法:在單因素試驗的基礎(chǔ)上,采用響應(yīng)面法,以圓整度、載藥率、丸重差異為評價指標,篩選成型工藝中的藥物與基質(zhì)質(zhì)量比、藥液溫度、制冷溫度;同時進行驗證試驗,考察最優(yōu)工藝所制滴丸的體外溶出度并與市售片劑進行比較。結(jié)果:布洛芬滴丸的最優(yōu)成型工藝為藥物與基質(zhì)質(zhì)量比1∶6,藥液溫度83℃,制冷溫度7.3℃。驗證試驗中自制滴丸的圓整度為0.945 9、載藥率為99.82%、丸重差異為0.040 28,含藥量約為30 mg/丸;綜合評分的實際值為0.972 5,與理論值(0.980 0)的偏差值為0.771 2%,RSD1.5%(n=3)。所制滴丸5 min溶出度為25.36%,30 min累積溶出度達到90.12%,與市售布洛芬片劑體外釋藥行為相似(f_2=54.91),符合一級藥動學(xué)方程。結(jié)論:該成型工藝方法簡單、穩(wěn)定可行;以優(yōu)化成型工藝所制滴丸可快速釋藥且重復(fù)性好。
[Abstract]:Objective: to study the molding technology of ibuprofen drop pills and determine its dissolution in vitro. Methods: on the basis of single factor test, response surface method was used to select the mass ratio of drug to matrix, liquid temperature, refrigeration temperature and validation test, taking roundness, drug loading rate and pill weight difference as evaluation indexes. The dissolution of the dropping pills prepared by the optimal technology was investigated and compared with the commercial tablets. Results: the optimum molding technology of ibuprofen drop pills was as follows: the mass ratio of drug to matrix was 1: 6, the liquid temperature was 83 鈩，

本文編號：2133781