Preparation Of Self-emulsifying Agent Of Brucea Javanica Oil

Brucea javanica oil is characterized by the poor solubility in water,low absorption in vivo by oral administration,large gastrointestinal irritation and poor patient compliance.The above problem would be resolved through preparing Brucea javanica oil self-emulsifying drug delivery systems.Our research provided practical basis for the development of Brucea javanica oil preparation.The initial prescription was decided by identifying surfactants and cosurfactants.Pseudo-ternary phase diagrams were used to identify the basic prescription of self-emulsion.The formulation of Brucea javania oil self-emulsifying drug delivery systems was optimized by Box-Behnken design-response surface method with size and time as indexes.The most optimum prescription was Brucea javania oil: Polyoxyethylene hydrogenated castor oil / Polyoxyethylene castor oil(1:1): polyethylene glycol 400=3:6:1.Then the temperature,dispersion method,different vehicle contents and volume were investigated to observe the effects on self-emulsifying efficiency.Brucea javanica oil self-emulsifying drug delivery system was formulated into self-emulsifying liquid hard capsule.The quality of Brucea javanica oil self-emulsifying liquid hard capsule was studied.The method was developed to determinate the content of Brucea javanica oil self-emusifying liquid hard capsule.The emulsion droplet after self-emulsification was about 135.7nm and the size distribution was narrow.Zata potential was about-8.9mV.Emulsion was stable after self-emulsification.The content of oleic acid was 10.07 mg/g.Brucea javanica oil self-emulsifying drug delivery system was formulated into free flowing granules and thereby prepared into hard capsule.Basing on the appearance and forming,we compared the different kinds of adsorbing materials,attenuants and agglutinates.Taking dissolution as index,the most optimum prescription of Brucea javanica oil self-emulsifying drug delivery system was self-emulsifying drug delivery systems: polyvinylpolypyrrolidone: dextrin: starch=2: 2: 1: 1 and moderate 10% starch paste.The qualities of Brucea javacina oil self-emulsifying solid hard capsule were studied.The method was developed for in vitro assay to determinate the content of Brucea javacina oil self-emulsifying solid hard capsule.The identification,particle size and moisture were accorded with Chinese Pharmacopoeia regulation.The emulsion droplet after self-emulsification was about 185.7nm and the size distribution was narrow.Emulsion was stable after self-emulsification.The content of oleic acid was 3.43 mg/g.The stability of packaging Brucea javanica oil self-emusifying liquid hard capsule and packaging Brucea javanica oil self-emusifying solid hard capsule was good.The detection indexes have not changed.The dissolution of Brucea javanica oil self-emusifying liquid hard capsule,Brucea javacina oil self-emulsifying solid hard capsule and reference soft capsule were determined.Compared with reference soft capsule,the dissolution rate of Brucea javanica oil self-emusifying liquid hard capsule and Brucea javacina oil self-emulsifying solid hard capsule was quick.Therefore,the two kinds of Brucea javanica oil self-emulsifying drug delivery systems formulations can improve the dissolution of Brucea javanica oil in vitro,and then the biological availability could be improved.