用于全肠外营养的海豹油脂肪乳的处方工艺研究.pdfVIP

摇 广东药学院学报 摇 Journal of Guangdong Pharmaceutical College摇 Apr.2011,27(2) 用于全肠外营养的海豹油脂肪乳的处方工艺 研究 苏健芬,郭喆霏,卓世添,温新国,彭新生,王荣昌,吴传斌 (中山大学药学院/ 广东省高校创新药物制剂工程技术研究中心/ 中山大学药物制剂工程研究开 发中心,广东 广州510006) 摘要:目的优化用于全肠外营养的海豹油脂肪乳的处方和工艺,并考察其性质。 方法 通过高速剪切法制 备初乳,再用高压均质法制备脂肪乳;以平均粒径、多分散系数(PDI)、Zeta 电位、离心稳定性常数等为评 价指标,通过归一化多项指标,用正交设计法优化制剂处方,同时考察影响其质量的工艺因素;将根据优化 处方和工艺制得的制剂分别置4、25 益考察稳定性。 结果 最佳处方(w)为:海豹油20%,卵磷脂E鄄80 0. 9%,泊洛沙姆1880.9%;优化工艺为:氮气保护下,采用60 MPa压力均质8次,灌封,121 益、灭菌15min; 所制备的脂肪乳pH值为7.0~7.5,平均粒径为(251.0 依3.1) nm,PDI 为(0.056 依0.012),Zeta 电位为 (-39.3依4.7) mV,主要脂肪酸二十碳五烯酸、二十二碳五烯酸、二十二碳六烯酸的质量分数分别为(2. 35依0.04)%、(0.95依0.02)%、(2.54依0.02)%;在4、25 益下避光放置3个月制剂稳定。 结论 本处方工 艺制备的脂肪乳性质稳定。 关键词:全肠外营养;海豹油;脂肪乳;高压均质法 Study on formulation and preparation process of seal oil based lipid emulsion for total parenteral nutrition SUJian鄄fen,GUOZhe鄄fei,ZHUOShi鄄tian,WENXin鄄guo,PENGXin鄄sheng,WANGRong鄄chang,WUChuan鄄 bin (School of Pharmaceutical Sciences,Sun Yat鄄sen University;Guangdong Research Centerfor Drug Delivery Systems;Research Development Center of Pharmaceutical Engineering,Sun Yat鄄sen University;Guangzhou, Guangdong 510006,China) Abstract:Objective To prepare stable seal oil based lipid emulsion for total parenteral nutrition(TPN) by optimizing itsformulationandpreparationprocessandinvestigatethephysicalproperties.MethodsThecoarse emulsion obtained by high鄄shear mixing was homogenized into a fine monodispersed emulsion with a high pressure homogenizer. The physical stability of emulsions was evaluated by the mean size, PDI(poly dispersion index),Zetapotentialandstabilityparametersofcentrifugation. Theformulationwasoptimizedby orthogonal design with normalized value and processing parameters that affecting the properties of the emulsion. The sealoilbasedlipidemulsionwasplacedundertheconditionof4 益 and25 益 respectivelyto investigate its stability.Results The optimized formulation and process parameters were as follo