CAJ | 학술논문

目的：制备非诺贝特自乳化半固体骨架胶囊并进行处方优化。方法以药物在不同油相中的溶解情况选择油相；采用伪三元相图法考察不同乳化剂形成微乳的能力和区域，绘制不同处方组成的伪三元相图；以体外乳化速率为评价指标筛选处方，并制备非诺贝特自乳化半固体骨架胶囊。结果该胶囊中的油相为油酸乙酯，乳化剂为Tween 80，助乳化剂为丙二醇，半固体载体为泊洛沙姆188，按优化处方制得的非诺贝特自乳化半固体骨架胶囊固化较快，37℃轻微搅拌条件下约2 min即可形成粒径（30±4）nm的微乳。结论成功制备非诺贝特自微乳半固体骨架胶囊，且工艺简单，易于工业化生产，具有良好的应用前景。
목적：제비비낙패특자유화반고체골가효낭병진행처방우화。방법이약물재불동유상중적용해정황선택유상；채용위삼원상도법고찰불동유화제형성미유적능력화구역，회제불동처방조성적위삼원상도；이체외유화속솔위평개지표사선처방，병제비비낙패특자유화반고체골가효낭。결과해효낭중적유상위유산을지，유화제위Tween 80，조유화제위병이순，반고체재체위박락사모188，안우화처방제득적비낙패특자유화반고체골가효낭고화교쾌，37℃경미교반조건하약2 min즉가형성립경（30±4）nm적미유。결론성공제비비낙패특자미유반고체골가효낭，차공예간단，역우공업화생산，구유량호적응용전경。
Objective Todeveloptheformulationoffenofibrateself-microemulsifyingsemi-solidmatrix hardcapsulesdrugdeliverysystem.Methods Thesolubilityoffenofibrateinoilwasinvestigatedtochoose the oil.Pseudoternary phase diagrams were used to evaluate the self-microemulsification existence area for different emulsifier and co-emulsifier.The rate of self-microemulsification in vitro as the index,the optimum formulation was determined for fenofibrate self-microemulsifying semi-solid matrix hard capsules. Results Intheoptimumformulation,ethyloleate,Tween80,propanediolandpoloxamer188wereseletedasoil phase,emulsifier,co-emulsifier,and semi-solid matrix,respectively.The fenofibrate self-microemulsifying semi-solid matrix hard capsules prepared according to the optimized formulation could form fine microemultion withtheparticlesizeof(32±4)nmwithin2min,undergentlestirringat37℃.Conclusion Enofibrate self-microemulsifying semi-solid matrix hard capsules was prepared successfully with a simple process.And it would be a promising formulation in the future.