用于全肠外营养的海豹油脂肪乳的处方工艺研究  

Study on formulation and preparation process of seal oil based lipid emulsion for total parenteral nutrition

作　　者：苏健芬[1,2,3] 郭喆霏[1,2,3] 卓世添[1,2,3] 温新国[1,2,3] 彭新生[1,2,3] 王荣昌[1,2,3] 吴传斌[1,2,3] 

机构地区：[1]中山大学药学院 [2]广东省高校创新药物制剂工程技术研究中心 [3]中山大学药物制剂工程研究开发中心,广东广州510006

出　　处：《广东药学院学报》2011年第2期111-115,共5页Academic Journal of Guangdong College of Pharmacy

基　　金：科技部国际科技合作与交流专项项目(2008DFA31080)

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℃考察稳定性。结果最佳处方（μ）为：海豹油20％，卵磷脂E一800．9％，泊洛沙姆1880．9％；优化工艺为：氮气保护下，采用60MPa压力均质8次，灌封，121oC、灭菌15min；所制备的脂肪乳pH值为7．0-7．5，平均粒径为（251．0±3．1）nm，PDI为（0．056±0．012），Zeta电位为（-39．3±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±0．04）％、（0．95±0．02）％、（2．54±0．02）％；在4、25℃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。Objective To prepare stable seal oil based lipid emulsion for total parenteral nutrition （TPN） by optimizing its formulation and preparation process and investigate the physical properties. Methods The coarse emulsion obtained by high-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）, Zeta potential and stability parameters of eentrifugation. The formulation was optimized by orthogonal design with normalized value and processing parameters that affecting the properties of the emulsion. The seal oil based lipid emulsion was placed under the condition of 4 ℃ and 25 ℃ respectively to investigate its stability. Results The optimized formulation and process parameters were as follows ： oil （ seal oil） phase 20%, egg lecithin （E-80） 0.9 %, poloxamer 188 （ F-68 ） 0.9 %, 60 MPa, 8 circles, under nitrogen circumstance. A fine lipid emulsion was prepared under good processing control with ivory appearance and a little bluish opalescence. The average particle size was （251.0 ± 3.1 ） rim, PDI （0. 056±0. 012）, the Zeta potential （ - 39.3 ± 4.7） mV, and the pH 7.0 ～7.5 and the contents of EPA, DPA, DHA in emulsion were （ 2.35± 0.04） % , （0.95 ± 0.02） %, （2.54 ± 0.02 ） % respectively. The seal oil based lipid emulsions at 4 ℃ and 25 ℃were stable for at least 3 months. Conclusion The optimized formulation and preparation orocess are feasible to preoare seal oil based lipid emulsion with good orooerties.

关 键 词：全肠外营养 海豹油 脂肪乳 高压均质法 

分 类 号：R944[医药卫生—药剂学]