酮康唑固体脂质纳米粒的制备及质量评价

Preparation and quality evaluation of ketoconazole solid lipid nanoparticles

[目的]制备酮康唑固体脂质纳米粒(SLN),并对其进行质量评价.[方法]采用微乳法制备酮康唑SLN,以包封率为评价指标,通过正交设计试验筛选最佳处方,并对其包封率、粒径等进行考察.[结果]按照最佳处方制备的酮康唑SLN在透射电子显微镜下呈圆整球形,大小分布均匀,平均粒径为61.7nm,Zeta电位为-23.84mV,平均包封率为75.75%.[结论]用本处方制备酮康唑SLN稳定,可行.

OBJECTIVE To study the preparation of ketoconazole solid lipid nanoparticles（SLN）and its quality evaluation.METHODS Microemulsion method was used to prepare ketoconazole SLN.The entrapment efficiency was used as the evaluation index.The optimum procedure was screened by the orthogonal design.The entrapment efficiency and the mean diameter of the particles were investigated.RESULTS Ketoconazole SLNs prepared by the optimum procedure were spherical and uniform under the transmission election microscopy.The mean particle size was 61.7nm,the Zeta potential was-23.84 mV and the mean encapsulation efficiency was 75.75%.CONCLUSIONThis preparation procedure of ketoconazole SLN was stable and feasible.