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目的采用Box-Behnken效应面法优化处方,制备姜黄素纳米结构脂质载体,并考察其理化性质。方法采用薄膜超声法制备载药纳米结构脂质载体,分别以药物质量浓度(X1)、总脂质质量浓度(X2)和混合乳化剂质量浓度(X3)为考察对象,以包封率(Y1)、粒径(Y2)为评价指标,利用三因素三水平Box-Behnken效应面设计法筛选载药纳米结构脂质载体的最佳处方。采用微柱离心法测定制剂的包封率,透射电镜观察其外观形态,动态光衍射法测定其粒径及Zeta,差示扫描量热法确证姜黄素在载体中的分散状态。结果最优处方制备的载药纳米结构脂质载体外形呈圆形或椭球形,粒径分布均匀,平均粒径为(58.37±2.60)nm,Zeta电位为-(22.6±0.88)mV,包封率为(93.48±0.86)%,DSC结果表明药物以非结晶状分散于纳米结构脂质载体中。结论采用Box-Behnken效应面法优化姜黄素纳米结构脂质载体处方是可行的。
OBJECTIVE To study the physicochemical properties of curcumin nanostructured liposomes using Box-Behnken effect surface methodology. Methods The drug-loaded nanostructured lipid carriers were prepared by thin-film ultrasonic method. Drug concentration (X1), total lipid concentration (X2) and mixed emulsifier mass concentration (X3) ) And particle size (Y2) were used as evaluation indexes to screen the best prescription of drug-loaded nanostructured lipid carriers by the three-factor and three-level Box-Behnken effect surface design method. The encapsulation efficiency of the preparation was determined by microcolumn centrifugation. The morphology of the preparation was observed by transmission electron microscopy. The particle size and Zeta were determined by dynamic light diffraction. The dispersion of curcumin in the carrier was confirmed by differential scanning calorimetry. Results The drug-loaded nanostructured lipid carriers prepared by the optimal prescription were round or ellipsoidal in shape with uniform particle size distribution (58.37 ± 2.60) nm and Zeta potential of (22.6 ± 0.88) mV, encapsulation The rate was (93.48 ± 0.86)%. The DSC results showed that the drug was dispersed in the nanostructured lipid carrier in an amorphous manner. Conclusion Box-Behnken effect surface optimization of curcumin nanostructured lipid carrier formulation is feasible.