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目的制备荆芥内酯聚乳酸乙醇酸纳米粒冻干粉末,并探讨其工艺与质量评价标准。方法以外观、色泽、再分散性为指标,优选支架剂的种类和浓度及冻干工艺;并对该冻干粉末的外观、再分散性、pH值、纳米粒的形态、粒径分布、多分散系数、质量分数、包封率及载药量等质量评价指标进行考察。结果10%甘露醇作为支架剂可以较好地防止纳米粒的聚集,优化的冻干工艺为-45℃预冻10 h,升温至-25℃维持5 h,再升温至-5℃维持2 h,再升温至10℃维持2 h,最后升温至30℃维持6 h。冻干粉末的外观和分散性良好,平均pH值为6.25,纳米粒平均粒径为80.2 nm,多分散系数为0.024 8,包封率为52.17%,载药量为28.73%。结论荆芥内酯纳米粒冻干粉末制备工艺简便、重复性好;所选用的质量评价方法适用于该冻干粉末,可有效反映其性质。
OBJECTIVE To prepare the nepetalactone polylactic acid glycolic acid nanoparticles freeze-dried powder and discuss the evaluation criteria of its technology and quality. Methods The appearance, color, redispersibility as index, the type and concentration of the scaffolds and the freeze-drying process were optimized. The appearance, redispersibility, pH value, morphology and size distribution of the freeze- Dispersion coefficient, mass fraction, entrapment efficiency and drug loading quality evaluation index were investigated. Results 10% mannitol could effectively prevent the aggregation of nanoparticles. The optimal freeze-drying process was pre-freezing at -45 ℃ for 10 h, warming to -25 ℃ for 5 h, then warming to -5 ℃ for 2 h , Then heated to 10 ℃ for 2 h, finally heated to 30 ℃ for 6 h. The appearance and dispersibility of the freeze-dried powder were good, the average pH was 6.25, the average size of the nanoparticles was 80.2 nm, the polydispersity was 0.024 8, the encapsulation efficiency was 52.17% and the drug loading was 28.73%. Conclusion The preparation method of nepetalactone nanoparticles freeze-dried powder is simple and reproducible. The selected quality evaluation method is suitable for the freeze-dried powder, which can effectively reflect its properties.