Preparation and quality evaluation of ginkgolide B-loaded self microemulsifying drug delivery system / 中国中药杂志

ABSTRACT

<p><b>OBJECTIVE</b>To prepare ginkgolide B-loaded self microemulsifying drug delivery system (SMEDDS) and evaluate its quality.</p><p><b>METHOD</b>The solubility of ginkgolide B in different oil, surfactant and co-surfactant were measured by HPLC-ESI-MS. The GB-SMEDDS formulation was optimized by the self emulsifying efficiency of various combinations of oil and mix-surfactant evaluated by using pseudo-temary phase diagram. The preliminary stability of GB-SEMEDDS was evaluated by the variety of loading rate of GB and dispersed medium. The morphology, the particle size and the formulation stability were evaluated after diluting by 0.1 mol x L(-1) HCl.</p><p><b>RESULT</b>The blank self microemulsified system was composed of ethyl oleate-( cremophor EL-lecithin-ethanol, 4 12) (40 60), the loading dosage was 2.5%. Little influence of GB and emulsified medium was observed on the stability of GB-SEMDDS. After diluted with 0.1 mol x L(-1) HCl, the morphology of the microemulsion was homogeneous small spherical drops observed under electro-microscope. The particle size was (41.6 +/- 1.11) nm, the self microemulsifing time was around 2 min. The formulation was stable within 8 h, without significant changes in particle size and separation of drugs.</p><p><b>CONCLUSION</b>GB-SMEDDS is easy to prepare and its quality is stable. The solubility of GB was significantly improved by SMEDDS.</p>