Development of self-emulsifying drug delivery system for oxymatrine phospholipid complex / 中草药

ABSTRACT

Objective To prepare oxymatrine (OMT) phospholipid complex (PC) self-emulsifying drug delivery system (OMT-PC- SEDDS), and evaluate its quality and release in vitro. Methods The emulsifiers, co-emulsifiers and ratio of emulsifier to co-emulsifier (Km) were selected through the pseudo-ternary phase diagram method, using emulsified area as selection index, investigation of oil phase by solubility was determined to optimize the prescription. The appearance, average particle diameter, self-emulsification time, in vitro release characteristics, and stability of OMT-PC-SEDDS were evaluated. Results The optimum prescription of OMT-PC-SEDDS was emulsifier Kolliphor HS 15 and co-emulsifier ethanol mass ratio of 21, the mass ratio of medium chain triglyceride (MCT) to the total mass of Kolliphor HS 15 and ethanol was 28. The appearance of OMTPC-SEDDS was translucent clear liquid with good stability. OMT-PC-SEDDS diluted with water to form milky and pale blue emulsion. The emulsion was observed to be spherical by transmission electron microscopy and distributed evenly with average particle size of (355.00 ± 19.50) nm and Zeta potential of (-12.80 ± 0.66) mV. In pH 6.8 phosphate buffer, the in vitro release, the in vitro release of OMT, OMT-PC, and OMT-PC-SEDDS respectively reached 93.84%, 88.39%, and 88.61% at 4 h. Conclusion The prepared OMT-PC-SEDDS by optimum formulation of this study has a good particle size and good stability.