Preparation and quality evaluation of gardenoside emulsion / 中草药

ABSTRACT

Objective To prepare water-in-oil gardenoside emulsion, optimize its formulation process, and evaluate the quality. Methods The formulation was optimized based on emulsification time, oil floating time and phase separation time, and investigated the optimal gardenoside emulsion by the single factor investigation and mixture design. The properties, stability, content, and in vitro release of the emulsion were also studied. Results The mean particle size of gardenoside emulsion was (5.48 ± 0.02) μm and the value of PDI was 0.125 ± 0.096; Centrifugation accelerated test was performed at 4 000 r/min for 15 min without delamination; The average mass fraction of gardenoside emulsion was 92.14% and RSD was 1.86% (n = 3); The in vitro release of gardenoside emulsions at pH 4.5, 6.8, and 7.4 was up to 105.32%, 98.41%, and 98.70%, respectively, while the in vitro release at pH 1.2 was up to 63.45%; Finally, the law of drug release was explained by fitting equation. Conclusion The high speed shear mechanical method can be used to prepare gardenoside emulsion, and the quality evaluation of the optimized prescription meets the requirements.