Résumé
Objective: To optimize the formulation of ginsenoside Rg3 self-emulsifying drug delivery by Box-Behnken experimental design (BBD) and evaluate its quality. Methods: Formulations were optimized using design of experiments by employing a 3-factor, 3-level BBD. Independent variables studied were the emulsifier, co-emulsifier, and the oil phase. The dependent variables were drug loading and average particle size. Through the BBD software, the response surface plots were drawn and the polynomial of influence of each factor index was obtained. Finally the formula optimization was obtained and the efficiency, droplet size, and dissolution rate of self-emulsifying drug delivery were investigated. Results: Optimum prescription was as follows: emulsifier [RH-400-Triton X-100 (1∶1)], co-emulsifier (isopropanol), and the oil phase (ethyl oleate). The optimum proportion was 3∶1.475∶0.5. The optimized ginsenoside Rg3 self-emulsifying drug delivery could fully emulsify in 5 min and the average drug loading was 917.53 μg/mL, average particle size was 111.6 nm. The dissolution degree in vitro of the formulations showed that the release rate and level were apparently superior to the conventional capsules. Conclusion: The observed responses are in close agreement with the predicted values of the mathematic models, and the BBD is suitable for optimizing ginsenoside Rg3 self-microemulsifying drug delivery.