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.
维普
万方数据