基于QbD理念优化黄体素类脂质体工艺研究

Optimization of the preparation process of lutein liposomes based on the QbD concept

目的制备黄体素类脂质体并优化处方。方法采用乙醇注入法制备黄体素类脂质体,以包封率和载药量为考察指标,基于QbD理念,利用Plackett-Burman试验设计结合Box-Behnken响应面法,优化药物和载体材料的比例、黄体素用量、水化温度等工艺参数。结果黄体素类脂质体最佳制备处方为表面活性剂比例0.703:1,叶黄素用量为15.4 mg,水化温度为32 ℃。验证试验黄体素类脂质体的包封率为(75.283±0.22)%、载药量为(38.152±0.21)%、OD值为0.794。结论利用Plackett-Burman试验设计结合Box-Behnken响应面法优化黄体素类脂质体制备工艺,此法预测性好,可行性强。

Objective To prepare lutein liposomes and optimize its praparation prescription.Methods On the basis of the QbD concept,by combining the Plackett-Burman experiment design with the Box-Behnken response surface method,lutein liposomes were prepared by ethanol injection and the encapsulation efficiency and drug loading were taken as the investigation indicators to optimize the ratio of the drug and carrier materials,dosage of lutein and hydration temperature.Results The optimal preparation prescription of lutein liposomes was as follows:The ratio of surfactant was 0.703:1,the dosage of lutein was 15.4 mg,and the hydration temperature was 32 ℃.In the validation test,the encapsulation efficiency of lutein liposomes was (75.283±0.22) %,the drug loading was (38.152±0.21) %,and the OD value was 0.794.Conclusion The preparation process of lutein liposomes is optimized by using the Plackett-Burman test design combined with the Box-Behnken response surface method,which proves to be highly predictive and feasible.