目的研究刺五加总苷自微乳的制备工艺和检测方法。方法考察了刺五加总苷在不同油、乳化剂、助乳化剂中的平衡溶解度,通过伪三元相图的绘制、含药自微乳释药系统自微乳化效率和稳定性考察,确定最佳处方;以刺五加中异嗪皮啶为指标,采用HPLC法测定其在微乳中的量。结果自微乳最佳处方:C af-丙二醇-亚油酸乙酯的比例为16:4:5;微乳的平均粒径为40 nm,异嗪皮啶的平均质量浓度为92. 6μg/mL。结论刺五加微乳粒径小,稳定性好。以异嗪皮啶为质量控制指标,方法准确可行。

Objective To develop self-microemulsifying drug delivery system(SMEIDDS)of Acanthopanax senticosus total saponins(ASTS)and the determination method. Methods The equilibrium solubility of ASTS in different compositions of oils. emulsifier and assistant emulsifier was investigated. The self-microenmlsion formula was optimized by constructing the pseudo-ternary phase diagrams of blank SMEDDS and the studying the self microemulsifying efficiency and the stability of drug-loaded SMEDDS. Taking isofraxidin, an effective component of A. senticosus, as the content determination index,the content was determined bv HPLC. Results The optimal self microemulsion formula was composed of Caf,propanediol. and ethyl linolenate. The ratio of them was 16：4：5. The average particle size was 40nm. The average content of isofraxidin was 92. 6 μg/mL. Conclusion The acquired mieroemulsion with small particle size is stable. The content determination method of iaking isofraxidin as the quality control index is accurate and reliable.