高能量全营养乳剂的稳定性优化研究OA

A tumor-specific,complete nutritional emulsion with an energy density of 1.5 kcal/mL was developed through integrated formulation design and process optimization.A comprehensive evaluation system was established,including Zeta potential,stability coefficient,particle size distribution,viscosity,centrifugal sedimentation rate,and nutrient degradation during storage.The optimized formulation was determined as follows:compound emulsifiers comprising glycerol citrate fatty acid ester(3 g/L)and mono-and diglycerides(3 g/L);carrageenan(0.3 g/L);and compound chelating agents consisting of sodium citrate(3 g/L)and potassium citrate(3 g/L).Optimal processing conditions included shear mixing at 5000 r/min for 20 min at 45℃,followed by homogenization(3 cycles at 200 bar plus 1 cycle at 450 bar)and sterilization at 121℃for 10 min.Scale-up production demonstrated excellent stability over a 12-month storage period:pH decreased by 0.2 units,centrifugal sedimentation rate≤4%,and the stability coefficient was≤0.06,with no observable oil separation or significant precipitation.Nutrient degradation followed the order:vitamin C(39.4%)＞vitamin B12(14.3%),while protein,fat,linoleic acid,α-linolenic acid,and vitamin B6 remained relatively stable.Under accelerated storage conditions,degradation rates for vitamin C and B12 were higher than under long-term storage,and linoleic/α-linolenic acids showed significant decreasing trends.In summary,the product exhibited superior physical stability and demonstrated strong potential for clinical applications in oncology nutrition.