中国中药杂志

2020, v.45(16) 3844-3851

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基于质量源于设计(QbD)理念的淫羊藿素-薏苡仁油微乳制备工艺研究
Development of preparation process of icaritin-coix seed oil microemulsion based on quality by design concept

曾华婷;郭健;刘聪燕;许婷;李瑞云;陈彦;
ZENG Hua-ting;GUO Jian;LIU Cong-yan;XU Ting;LI Rui-yun;CHEN Yan;Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine;Multi-component of Traditional Chinese Medicine and Microecology Research Center,Jiangsu Provincial Academy of Chinese Medicine;

摘要(Abstract):

基于质量源于设计(QbD)理念优化淫羊藿素-薏苡仁油微乳(IC-MEs)的处方配比及制备工艺。采用水滴定法制备IC-MEs。评估可能影响IC-MEs质量的风险因素,采用Plackett-Burman设计筛选影响处方及工艺的显著性参数,并通过Box-Behnken设计优化IC-MEs的处方配比。风险评估和Plackett-Burman试验确定了药辅比、混合油相(薏苡仁油-甘油三丁酸酯)与混合表面活性剂(HS15-RH40)的比例、加水量3个处方因素为影响IC-MEs的关键因素。Box-Behnken设计建立的回归模型具有良好预测性,并确定IC-MEs的最佳处方为药辅比为0.92%,混合油相(薏苡仁油-甘油三丁酸酯)与混合表面活性剂(HS15-RH40)的比例为4∶6,加水量为5.7 mL。经试验验证,最佳制剂处方1周后的包封率为92.45%±1.00%。基于QbD理念优化的IC-MEs处方及工艺参数,有助于提高IC-MEs的质量稳定性,为其今后的开发应用提供了实验基础。
To optimize the formulation and preparation process of icaritin-coix seed oil microemulsion(IC-MEs) based on quality by design(QbD) concept. IC-MEs were prepared by water titration. Firstly, the risk factors that may affect the quality of IC-MEs were evaluated. Then Plackett-Burman design was used to screen out prescription factors and process parameters that had a significant effect on the indicators. Finally, Box-Behnken design was used to optimize the prescription ratio of IC-MEs. Through the risk assessment and Plackett-Burman design, three formulation factors [drug loading efficiency, the ratio of mixed-oil(coix seed oil-Glycerol tributyrate) to mixed-surfactant(HS15-RH40) and water addition] were determined as the key factors affecting IC-MEs. The regression model established by Box-Behnken design had a good predictability. The optimal formula was as following: the drug loading efficiency of 0.92%, the ratio of mixed-oil(coix seed oil-glycerol tributyrate) to mixed-surfactant(HS15-RH40) of 4∶6, and the water addition of 5.7 mL. According to this prescription, IC-MEs were prepared, and its encapsulation efficiency after 1 week was 92.45%±1.00%. Therefore, the stability of IC-MEs could be improved by optimizing prescription and process parameters of IC-MEs based on the QbD concept, which can provide certain reference value for the future development of IC-MEs.

关键词(KeyWords): 质量源于设计;淫羊藿素;薏苡仁油;微乳
quality by design;icaritin;coix seed oil;microemulsion

Abstract:

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基金项目(Foundation): 国家自然科学基金项目(81873016);; 江苏省科教强卫医学重点人才项目(ZDRCA2016036)

作者(Author): 曾华婷;郭健;刘聪燕;许婷;李瑞云;陈彦;
ZENG Hua-ting;GUO Jian;LIU Cong-yan;XU Ting;LI Rui-yun;CHEN Yan;Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine;Multi-component of Traditional Chinese Medicine and Microecology Research Center,Jiangsu Provincial Academy of Chinese Medicine;

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