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目的基于质量源于设计(Qb D)理念优化穿心莲内酯(And)固体脂质纳米粒(And-SLNs)。方法采用热熔乳化-高压均质法制备And-SLNs。以And-SLNs的包封率、粒径分布为评价指标,首先应用Plackett-Burman实验设计筛选出对And-SLNs性质影响显著的处方和工艺变量,然后对筛选出的变量应用Box-Behnken效应面法进一步优化。采用Malvern粒度仪测定And-SLNs的粒径分布和Zeta电位,透射电镜考察其形态;并考察And-SLNs的体外释药行为。结果 And-SLNs的包封率为(91.4±3.7)%,粒径为(258.4±42.1)nm,Zeta电位为(-36.1±3.4)m V,透射电镜显示And-SLNs粒径均一,呈球状分布,48 h累积释放度为52.4%。结论在And-SLNs开发过程中应用Qb D理念优化是可行的。
Objective To optimize And-And-SLNs based on the QbD concept of quality. Methods And-SLNs were prepared by hot-melt emulsification-high pressure homogenization. The encapsulation efficiency and particle size distribution of And-SLNs were used as evaluation indexes. The Plackett-Burman experimental design was used to screen prescription and process variables that have significant effect on the properties of And-SLNs. Then, the Box-Behnken effect surface Law to further optimize. The particle size distribution and Zeta potential of And-SLNs were determined by Malvern particle sizer. The morphologies of the cells were investigated by transmission electron microscopy. The in vitro release behavior of And-SLNs was also investigated. Results The entrapment efficiency of And-SLNs was (91.4 ± 3.7)%, the diameter was (258.4 ± 42.1) nm and the zeta potential was (-36.1 ± 3.4) mV. Distribution, 48 h cumulative release of 52.4%. Conclusion It is feasible to apply Qb D concept optimization in the development of And-SLNs.