首页|星点设计-效应面法优化阳离子纳米乳递送系统的处方工艺研究

星点设计-效应面法优化阳离子纳米乳递送系统的处方工艺研究

Optimization of cationic nanoemulsion delivery system by star design-effect surface method

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目的 采用单因素试验和星点设计-效应面法优化阳离子纳米乳(CNE)的处方工艺,并对其药剂学性能进行评价.方法 以平均粒径(D50)、粒径范围、离心稳定性常数(Ke)和电位为评价指标,单因素试验筛选CNE的油相种类、乳化剂种类及用量、甘油及十八胺用量、剪切时间,高压均质压力及时间,星点设计效应面法考察均质压力和时间对CNE的影响,用二项式及多元线性回归模型拟合建立指标与因素之间的关系,效应面法获取最佳处方.结果 CNE最佳处方组成为中链脂肪酸甘油三酯(MCT)0.5 g,大豆卵磷脂1 g,十八胺53.90 mg,甘油0.8 g,其余为水相;最佳处方所得CNE外观基本圆整,澄清透明,D50为(135.08±5.69)nm,Zeta电位为(43.57±2.51)mV,离心、稀释、时间稳定性均良好.结论 优化得到的CNE为淡蓝色均一乳状液、稳定性良好粒径合适,可为核酸药物递送系统的开发提供参考.
Objective To optimize the formulation process of cationic nanoemulsion(CNE)and evaluate its pharmaceutical properties using single-factor test and star design-effect surface method.Methods With particle size(D50),particle size range,centrifugal stability constant(Ke),and potential as the evaluation indexes,single-factor test was conducted to screen the type of oil phase,type and dosage of emulsifier,dosage of glycerol and Octadecanamine,shear time,high pressure,homogeneous pressure and time,and the effects of homogeneous pressure and time on CNE were investigated by Star point design effect surface method.Binomial and multiple linear regression models were used to establish the relationship between indexes and factors,and the optimal prescription was optimized by effect surface method.Results The optimum components of CNE included medium chain triglyceride(MCT)0.5 g,soy lecithin 1 g,octachylamine 53.90 mg,and glycerol 0.8 g;The rest was water phase.The appearance of the CNE was basically round,clear and transparent;D50 was(135.08±5.69)nm and Zeta potential was(43.57±2.51)mV,and the centrifugation,dilution,time stability were good.Conclusion The optimized CNE is a light blue homogeneous emulsion with suitable particle size and good stability,which can provide reference for the development of nucleic acid drug delivery system.

cationic nanoemulsionoctadecylaminenucleic acid drugcardiovascular diseasesingle factor teststar design-effect surface method

张丽丹、唐永瑜、汪巳卜、陈英、吴兴杰、沈祥春、陶玲

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贵州医科大学药学院

贵州省特色天然药物资源高效利用工程中心

贵州省高等学校天然药物药理与成药性评价特色重点实验室

天然药物资源优效利用重点实验室,贵州贵阳 550025

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阳离子纳米乳 十八胺 核酸药物 心血管疾病 单因素试验 星点设计-效应面法

贵州省科技计划项目贵州省高层次创新型人才百层次人才项目贵州医科大学药学国际科技合作基地贵州省科技创新基地贵州省高层次创新型人才十层次人才

黔科合支撑[2020]4Y240贵州科技厅黔科合人才[2015]4029黔科合平台人才[2017]5802黔科合中引地[2023]003黔科合平台人才-GCC[2023]048

2024

10.19367/j.cnki.2096-8388.2024.04.008

贵州医科大学学报
贵阳医学院

贵州医科大学学报

CSTPCD
影响因子：0.827
ISSN：2096-8388
年,卷(期)：2024.49(4)
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