Preparation of the oral self-microemulsifying drug delivery system of GBE50

To prepare the oral self-microemulsifying drug delivery system (SMEDDS) of GBE50, balance solubility method was used to screen emulsifier and assistant emulsifier; a pseudo-temary phase diagram was used to prepare microemulsion; and orthogonal design was used to optimize formulation.  Self-microemulsifying efficiency, dissolution, stability and pharmacokinetics of the preparation were studied.  As a result, GBE50- SMEDDS of IPM, Cremophor EL, 1,2-propanediol and GBE50 could be self emulsified to form stable microemulsion with particle diameter between 20 and 50 nm when emulsifying with water.  Its self-microemulsifying efficiency and dissolution are quick with good stability and it has a higher bioavailability than market existing agents Xingling particles.  GBE50-SMEDDS is stable and effective.