穿心莲内酯自乳化软胶囊的制备和溶出度评价

目的研制穿心莲内酯自乳化软胶囊,并对其溶出度进行评价。方法制备穿心莲内酯自乳化软胶囊,通过穿心莲内酯溶出条件的筛选,考察自乳化软胶囊与市售片剂的溶出曲线。结果穿心莲内酯自乳化释药系统处方为油酸乙酯（10%）、吐温80（54%）、正丁醇（36%）。采用药典2005年版二部溶出度测定第一法,以0.2%SDS为溶出介质,穿心莲内酯自乳化软胶囊与穿心莲内酯片溶出度有显著性差异。结论自乳化软胶囊能显著提高穿心莲内酯的体外溶出度。

Study on preparation and dissolution of andrographolide self-emulsifying drug delivery soft capsules

Objective To prepare the andrographolide self-emulsifying drug delivery soft capsules(ASESC) and evaluate its quality.Methods The andrographolide self-emulsifying soft capsules were prepared.To screen the dissolution of andrographolide,the dissolution media and dissolution method of Ch.P were analysied.The dissolution of SMESC was measured,taking the commercial capsule as reference.Results The self-emulsifying drug delivery system was composed of ethyl oleate(10%),Tween 80(54%),n-Butanol(36%).The percent of accumulated dissolution of andrographolide in self-emulsifying drug delivery soft capsules in 0.2% SDS fluid was up to 70% at 45 min,which was far more than the commercial capsule.Conclusion The andrographolide self-emulsifying drug delivery capsules has been successfully prepared,and the dissolution of andrographolide was remarkably improved.