注射用地塞米松固体脂质纳米粒冻干粉末的处方与工艺研究及质量评价

目的:研究注射用地塞米松(DXM)固体脂质纳米粒(SLN)冻干粉末的处方及工艺并评价其质量。方法:优选支架剂处方,确定冻干工艺制备冻干制剂;采用高效液相色谱法测定其中DXM的含量,并对其质量进行研究。结果:以3%甘露醇作为支架剂,DXM-SLN的粒径为340nm,Zeta电位为—25·2mV,包封率为92·10%,载药量为7·10%,于2~8℃环境下可保存3个月。结论:该制备工艺简便、可行,质量控制方法准确、可靠。

Formulation,Technology and Quality Evaluation of Dexamethasone Solid Lipid Nanoparticles Lyophilized Injection

OBJECTIVE： To study the formulation and technology of dexamethasone solid lipid nanoparticles（DXMSLN） 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.