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目的:用微乳法制备左旋多巴固体脂质纳米粒(LDP-SLN),并建立包封率的测定方法。方法:通过绘制三元相图,采用微乳法制备LDP-SLN,用TEM和激光粒度仪进行了颗粒形貌和粒径分布的研究,用葡聚糖凝胶层析法分离测定包封率。对其粒径、形态、包封率等理化性质进行研究,并考察其稳定性。结果:实验制得LDP-SLN为稳定的略泛蓝色乳光的纳米混悬液,在透射电镜下显示为较为均匀的球体,激光粒度测定平均粒径为108nm,多分散系数1.153;4℃放置2个月,粒径、包封率无显著变化。包封率测定的线性范围为2～100mg·mL-1,线性良好(r=0.9999),精密度符合要求,LDP-SLN上柱洗脱后分离度和回收率均符合要求。结论:该研究中制备了物理性质较为稳定的LDP-SLN,建立了合适的包封率测定方法,并考查初步稳定性较好。
OBJECTIVE: To prepare levodopa solid lipid nanoparticles (LDP-SLN) by microemulsion method and to establish the determination method of encapsulation efficiency. Methods: LDP-SLN was prepared by microemulsion method through the mapping of ternary phase diagram. The morphology and particle size distribution of LDP-SLN were studied by TEM and laser particle sizer. The encapsulation efficiency was determined by dextran gel chromatography . The particle size, morphology, entrapment efficiency and other physical and chemical properties were studied, and investigated its stability. Results: LDP-SLN was a stable nanosuspension with a little blueish opacity and showed a uniform sphere under transmission electron microscopy. The average size of laser particle size was 108nm and the polydispersity index was 1.153. Placed 2 months, particle size, encapsulation efficiency no significant change. The linearity range was 2 ~ 100 mg · mL-1 and the linearity was good (r = 0.9999). The precision meets the requirement. The separation and recovery of LDP-SLN were satisfactory. Conclusion: The LDP-SLN with stable physical properties was prepared in this study. The suitable method for determining the entrapment efficiency was established and the initial stability was tested.