交泰丸活性组分自微乳化系统的研究  

Study on Self-microemulsifying Drug Delivery System of Jiaotai Pill Active Components

作　　者：张倍恩[1] 卢文彪[1] 陈蔚文[1] 

机构地区：[1]广州中医药大学,广东广州510006

出　　处：《中药材》2008年第7期1068-1071,共4页Journal of Chinese Medicinal Materials

摘　　要：目的:研究交泰丸活性组分自微乳化系统的组方和质量控制方法。方法:考察盐酸小檗碱在不同辅料中的溶解度及乳化剂和助乳化剂对肉桂油的乳化能力,确定最佳处方;以盐酸小檗碱和桂皮醛为指标,用HPLC法测定两者在自微乳化系统中的含量。结果:交泰丸自微乳化最佳处方为OP-(1,2-丙二醇)-肉桂油-黄连生物碱,其比例为4∶8∶3∶6;形成微乳的平均粒径为15.8nm,自微乳化处方中盐酸小檗碱的含量≥20.0%,桂皮醛的含量≥10.0%。结论:交泰丸活性组分自微乳化系统形成的微乳粒径小,稳定性好;以盐酸小檗碱和桂皮醛为质量控制指标,方法准确可行。Objective：To develop self-microemulsifying drug delivery system（SMEDDS）of Jiaotai Pill active components and its quality control method.Methods：The solubility of berberine hydrochloride in different auxiliary-materials were investigated,and the self-microemulsion formula was optimized by studying the self-microemulsifying efficiency.The content of berberine hydrochloride and cinnamaldehyde in the preparation were determined by HPLC.Results：The optimal self-microemulsion formula was composed of OP,propanediol,cinnamon oil,and total alkaloid from Rhizoma Coptidis with the ratio of 4∶8∶3∶6.The average size of the microemulsion particle was 15.8nm;the average content of berberine hydrochloride and cinnamaldehyde in the preparation was above 20.0% and 10.0%,respectively.Conclusion：The acquired microemulsion with small particle size is stable.The determination method of berberine hydrochloride and cinnamaldehyde in the preparation is accurate and reliable.

关 键 词：交泰丸 自微乳化系统 盐酸小檗碱 桂皮醛 高效液相 

分 类 号：R286.02[医药卫生—中药学]