Objective: To optimize prescription of ginkgolide B (GB) self-microemulsifying drug delivery systems (SMEDDS) and evaluate its quality and security. Method: With particle size

Zeta potential

equilibrium solubility as indexes

the mass fraction of oil phase

ratio of surfactant and co-surfactant

rate of the mixed surfactant as factors

pseudo-ternary phase diagram and central composite design and response surface method were adopted to optimize prescription.The content of GB was determined by HPLC.Morphology

pH value

particle size distribution

Zeta potential

stability and some security of GB-SMEDDS were studied. Result: Optimal prescription was GTCC/EL-35/lecithin/ethanol (25.99:39.47:9.87:24.67)

while the drug loading and particle size were (24±1.4) g·L-1 and 30-60 nm

respectively. The preparation was stable under different temperature for a week

including 25

40

4

-20℃.Stability of prepared GB-SMEDDS was good in the state of normal temperature

high temperature and low temperature within 1 week

its had good security. Conclusion: Central composite design-response surface method had successfully built a model for optimizing formulation of GB-SMEDDS optimized preparation technology of GB-SMEDDS was simple

repeatable and stable with good prediction.