注射用奥沙利铂纳米结构脂质载体冻干制剂的工艺优选

摘要

Objective To investigate the freeze-drying formulations of oxaliplatin in oxaliplatin-loaded nanostuctured lipid carriers( OP-NLC) for injection. Methods The optimum freeze-drying preparation and techniques were established by single factor experiments and the characters were evaluated. Results The optimal freeze-drying technology was determined with 5% of mannitol as protective agent. No significant changes were found in the mean particle size, Zeta potential and EE% , which were (124±6) nm versus ( 115±7) nm,10.8 mV versus 16. 0 mV, and 67. 3% versus 72. 6% post- and pre-freeze-drying, respectively. Conclusion The stable freeze-drying preparation of OP-NLC could be prepared under the optimal condition.%目的 考察注射用奥沙利铂纳米结构脂质载体(OP-NLC)冻干粉末处方及工艺.方法 通过单因素实验优选冻干制剂的处方工艺,并评价其制剂学性质.结果 以5％甘露醇溶液作为冻干保护剂,确定最终的冻干工艺.冻干后制剂粒径(124±16) nm,Zeta电位-10.8 mV,包封率67.3％,与冻干前[粒径(115±17) nm,Zeta电位-16.0 mV,包封率72.6％]相比,无明显变化.结论 在优选的冻干工艺条件下可制得稳定的奥沙利铂纳米结构脂质载体冻干制剂.