摘要
目的研制灯盏花素固体自微乳剂(灯盏花素-SSMEDDS),并考察其体外溶出度。方法通过伪三元相图优化处方工艺,研究自微乳化系统中的油相、乳化剂及助乳化剂的组成和用量,筛选灯盏花素固体自微乳剂的最佳处方,并考察其理化性质及体外溶出度。结果灯盏花素固体自微乳剂的处方中,灯盏花素、GTCC、吐温-20、PEG-400、Transcutol-P、甘露醇的质量比为0.75∶0.69∶10.0∶7.02∶16.36∶65.17;乳滴粒径为34.62 nm;溶出度受溶出介质的影响为:人工肠液>水>人工胃液。结论自微乳剂能够改善灯盏花素的难溶性,固体自微乳剂的制备工艺简单,具有良好的应用前景。
OBJECTIVE To prepare Breviscapine solid self-microemulsifying drug delivery system（Bre-SSMEDDS） and study its dissolution in vitro.METHODS The solubility of breviscapine in different oil,emulsifier and co-emulsifier were measured by ultraviolet spectrophotometry（UV）.The breviscapine-SSMEDDS formulation was optimized by analyzing the self-microemulsifying efficiency of various combinations of oil,emulsifier and co-emulsifier and evaluated by pseudo-ternary phase diagram.Meanwhile,the dissolution and the physicochemical properties were assessed.RESULTS The optimum formulations of breviscapine-SSMEDDS were composed of breviscapine,GTCC,Tween 20,PEG-400,Transcutol-P and mannitol at the ratio of 0.75：0.69：10.0：7.02：16.36：65.17.The particle size of breviscapine was 34.62 nm.The dissolution was affected by the type of solvent,phosphate buffer solution（pH6.8）waterartificial gastric juice.CONCLUSION Breviscapine-SSMEDDS can improve the solubility of Breviscapine.The preparation procedure is simple,and has a good applicable prospect.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2012年第5期540-543,共4页
West China Journal of Pharmaceutical Sciences
关键词
灯盏花素
固体自微乳
溶出度
Breviscapine
Solid self-microemulsion
Dissolution
