[Optimization and characterization of SalB-pC loaded self-emulsifying drug delivery system]

To prepare self-emulsifying delivery system (SEDDS) of Salvianolic acid B phospholipid complex (SalB-PC) and evaluate its quality.

The best formulation was optimized using single-factor and pseudo-ternary phase diagrams, according to the emulsifying efficiency, the characteristics and partical size of the emulsion and other indicators. The morphology, particle size, zeta-potential and the release in artificial intestinal fluid of self-emulsifying formulation were evaluated.

The weight ratio of SalB-PC: Lauroglycol FCC:Cremophor EL:Transcutol P in the best formulation was 9:45:40:15. SalB-PC loaded self-emulsifying formulation is yellow and transparent solution, with partical size about (187.2 +/- 7.1) nm, polydispersity index (PDI) about 0.267 +/- 0.008 and zeta-potential about (-35.6 +/- 2.7) mV after diluted about 100-fold. The self-emulsifying formulation released slower than the solution with only SalB or SalB-PC.

Water-soluble drug Salvianolic acid B can be prepared to SEDDS, and this formulation can slow down the release of SalB in artificial intestinal fluid.