ABSTRACT
Objective To optimize the formulation of self-microemulsifying drug delivery systems containing tanshinone ⅡA(tanshinone ⅡA-SMEDDS) and assess the quality of tanshinone ⅡA-SMEDDS. Methods Pseudoternary phase diagrams were used to choose the oil,emulsifier,co-emulsifier,and their proportion in the formulation on the basis of the ability to form emulsions and regions. Then the self-emulsifying time,droplet and morphology,size distribution,?-potential,stability,and other aspects of the quality were evaluated. Results The formulation of tanshinone ⅡA-SMEDDS was as follows:ethyl oleate-Labrasol-PEG 400=10%:45%:45%,drug loading ratio was 2.25 mg/g. The self-microemulsifying time of tanshinone ⅡA-SMEDDS in 0.1 mol/L hydrochloric acid solution was less than 1 min,the emulsion drops were spherical shape with average particle size of (84.9?2.1) nm and the average ?-potential (-24.0?1.15) mV (n=3). So tanshinone ⅡA-SMEDDS was stable. Conclusion In this paper,the tanshinone ⅡA-SMEDDS has a good self-emulsifying performance. It is expected to further stabilize the preparation of tanshinone ⅡA self-microemulsifying agents.
ABSTRACT
Objective To study the preparation of Fructus perrillae oil nanoemulsion and its quality evaluation. Methods The formulations of Fructus Perrillae oil nanoemulsion were optimized by drawing the pseudoternary phase diagrams and investigating the form, viscosity, particle size distribution, stability, conductance, and refractiratio. Results The optimal formulation was composed of wheat oil and cremophor RH40, electron microscopy presented Fructus Perrillae oil nanoemulsion as small spherical drops, viscosity was (5.49?0.02)/mm2?s-1, conductance was 316/ms-1, refractiratio was (1.124?0.002 50), and mean diameter of particle was (50.3?1.1) nm.The average recovery determined by GC was 98.9%, its mean RSD was 0.88%. Conclusion The solubility and stability of Fructus Perrillae oil are promoted by nanoemulsion with better produncibility. It is a favorable medical matrix.