川芎油自乳化释药系统体外评价

In vitro evaluation of self-emulsifying drug delivery system of volatile oil from rhizome of Ligusticum chuanxiong

目的:探讨川芎油自乳化释药系统(VOC SEDDS)体外评价方法。方法:通过研究VOC SEDDS自乳化效率、成乳后乳剂性质和体外溶出行为对VOC SEDDS进行体外评价。结果:优选出的自乳化处方5 min内已基本乳化完全,乳化后乳滴的平均粒径为102 nm左右,ζ电位均在-30 mV左右,离心稳定性良好;成乳后得到O/W型乳剂;处方重现性高;以藁本内酯为指标,体外溶出结果表明30 min内药物的体外溶出可达80%;光照和高温条件下稳定性良好。结论:VOC SEDDS自乳化能力强,稳定性好,体外溶出率高。

Objective： To investigate the evaluation method for self-emulsifying drug delivery system of volatile oil from rhizome of Ligusticum chuanxiong （VOC SEDDS）. Method： The self-emulsifying ability, the efficiency of self-emulsification, the properties of emulsion, the dissolution of volatile oil from Rhizome of Ligusticum Chuanxiong and the stability of the emulsion were determined. Result： The optimized formulation can fully emulsify in 5 min and the particle sizes were around 102 nm. Zeta potential was about -30 mV. The O/W emulsions were stable through centrifugation with high reproducibility. In vitro dissolution test indicated that over 80% of drug dissolved in 30 min and VOC SEDDS was stable under light and high temperature in 10 d. Conclusion： VOC SEDDS has strong self-emulsifying ability, fine stability and high dissolution rate in vitro.