Formulation,Technology and Quality Evaluation of Dexamethasone Solid Lipid Nanoparticles Lyophilized Injection / 中国药房

ABSTRACT

OBJECTIVE: To study the formulation and technology of dexamethasone solid lipid nanoparticles(DXM-SLN) lyophilized injection and evalnate it's quality. METHODS: The formulation of the supporting agent was optimized and the preparation technology of lyophilized injection was established to prepare the lyophilised injection. The content of DXM in the sample was determined and its quality was investigated as well. RESULTS: 30% mannitol was supporting agent, the particle size of DXM-SLN was 340 nm, with zeta potential at -25.2 mV, entrapment ratio at 92.10% and drug-loading at 7.10%. It was stable within 3 months' at 2～8 ℃storing. CONCLUSION: The preparation technique of this preparation is simple and feasible and its quality is stable and controllable.