Preparation and Quality Evaluation of Itraconazole Self-emulsifying Solution / 中国药房

ABSTRACT

OBJECTIVE:To prepare itraconazole self-emulsifying solution and evaluate its quality.METHODS:Through equilibrium solubility experiment,the formulation of itraconazole self-emulsifying solution was obtained by optimizing the compatible ratio of oil phase with emulsifier and co-emulsifier.The morphology,particle size,zeta potential and drug loading content of the microemulsion were examined after being diluted by water.RESULTS:The formulation of the self-emulsifying solution was tocopherol acetate (oil phase)-Transcutol P (emulsifier)-Cremophor RH40 (co-emulsifier) (3∶12∶5).The morphology of microemulsion was homogeneous small spherical drops observed under the electron microscope,with particle size and Zeta potential at (296.1?90.7) nm and (—13.2?1.6) mV,respectively.The drug loading con-tent was 9.88%.CONCLUSION:The itraconazole self-emulsifying solution was proved to be stable and reliable in quality.