摘要
目的通过优化处方配比制备盐酸小檗碱纳米乳,并评价其理化性质(外观、粒径)及稳定性。方法以溶解度及纳米乳外观为指标筛选分组,确定纳米乳处方组成。考察纳米乳粒径、多分散指数及短期稳定性。结果盐酸小檗碱纳米乳的最优处方组成为油酸(4.28%)、吐温-80(8.14%)、乙醇(16.14%)和水相(71.4%)。所得纳米乳为亮黄色澄明液体;平均粒径为(150.09±12.19)nm,多分散指数为(0.24±0.01),载药量为0.04%。室温储存7 d内,体系无明显聚集及粒径变化。结论采用加水滴定法制备的盐酸小檗碱纳米乳稳定性良好,为其临床应用提供了一种新剂型。
Objective To optimize the formulation composition and ratio for preparing berberine hydrochloride nanoemulsion and evaluate its physicochemical properties(appearance,particle size)and stability.Methods Based on solubility tests and visual assess-ment of nanoemulsion morphology,the optimal formulation components were screened and determined.The prepared nanoemulsion was characterized for particle size distribution,polydispersity index(PDI),and short-term stability.Results The optimal formulation con-sisting of oleic acid(4.28%),Tween-80(8.14%),ethanol(16.14%),and aqueous phase(71.4%).The prepared nanoemulsion appeared as a clear and bright yellow liquid,with an average particle size of(150.09±12.19)nm,a PDI of(0.24±0.01),and a drug loading capacity of 0.04%.No significant aggregation or changes in appearance or particle size were observed during 7 days of storage at room temperature.Conclusion The berberine hydrochloride nanoemulsion prepared via the water titration method exhibited superior stability,offering a promising novel dosage form for the clinical applications.
作者
任俊树
雷艳丽
蔡雅琴
REN Junshu;LEI Yanli;CAI Yaqin(Department of Preparation Center,General Hospital of Ningxia Medical University,Yinchuan Ningxia 750004,China;School of Basic Medical Science,Ningxia Medical University,Yinchuan Ningxia 750004,China;Department of Pharmacy,Ningxia Hui Autonomous Region People's Hospital,Yinchuan Ningxia 750004,China)
出处
《天津药学》
2025年第7期774-777,共4页
Tianjin Pharmacy
基金
宁夏自然科学基金项目(2023AAC03478)。
关键词
盐酸小檗碱
纳米乳
粒径
稳定性
Berberine hydrochloride
Nanoemulsion
Particle size
Stability
