三七总皂苷壳聚糖纳米粒冻干粉的制备工艺研究

The Study on Preparation Technology of Lyophilized Powder of Panax Notoginseng Saponin Chitosan Nanoparticles

为提高三七总皂苷壳聚糖纳米粒(PNS-NPs)的稳定性,采用冷冻干燥法制备冻干粉并优化其冻干工艺.通过离子凝胶法制备PNS-NPs,以再分散性、粒径分布及微观形态及药物渗漏率为指标,进行全面实验和配伍实验筛选最优冻干工艺.结果表明:PNS-NPs冻干粉最佳制备工艺为预冻时间12 h、冻干保护剂为2.5%蔗糖+2.5%海藻糖.在该条件下制得的冻干粉分散性好、无粘连,扫描电镜显示其微观形貌呈球形;分散后粒径为(138.30±3.15)nm,相比于冻干前原液有所增加,但各组分药物渗漏率均未超过5%.PNS-NPs冻干粉有望成为PNS纳米新剂型.

To improve the stability of panax notoginseng saponin chitosan nanoparticles(PNS-NPs),freeze-dried powder is prepared by freeze-drying method and its freeze-drying process is optimized.PNS-NPs are prepared by ion cross-linking method.The optimal lyophilization process is performed by comprehensive experiments and compatibility experiments with re-dispersibility,particle size distribution,microscopic morphology and drug leakage rate.The results show that the optimal preparation process of PNS-NPs lyophilized powder is 12 h pre-freezing time and 2.5%sucrose+2.5%trehalose mixed protective agent.The lyophilized powder prepared by this condition has good dispersibility and no adhesion.Scanning electron microscopy result shows that the microscopic morphology is spherical.The particle size after dispersion is(138.30±3.15)nm,which is increased compared with the original solution before lyophilization,but the drug leakage rates don′t exceed 5%.PNS-NPs freeze-dried powder is expected to become a new nano-drug formulation of PNS.