Centre for Drug Delivery Research, Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Parenteral Nutrition Unit, Department of Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Daru. 2019 Jun;27(1):191-201. doi: 10.1007/s40199-019-00262-7. Epub 2019 Apr 24.
Intravenous lipid emulsion (IVLE) was first used to prevent essential fatty acids deficiency. IVLE with α-tocopherol was reported to provide protection against parenteral nutrition-associated liver disease. This study aims to determine the optimal parameters and conditions in developing a physically stable IVLE from superolein palm oil (SoLE 20%) and its effect on lipid and liver profiles in an animal model.
SoLE 20% was prepared using superolein oil and MCT oil (1:1), stabilized with egg lecithin and homogenized using a high pressure homogenizer. Mean droplet size was used as the response variable and was measured using laser diffraction and dynamic light scattering method. Physical stability at 4 °C, 25 °C and 40 °C storage temperatures were determined based on particle size and distribution, polydispersity index, zeta potential, viscosity, vitamin E contents and pH. Sterility and pyrogenicity were also investigated. Rabbits were administered with 1.0 g/kg SoLE 20% for 5 h and repeated daily for 3 days to investigate its effect on blood lipid and liver enzymes profile.
SoLE 20% was succesfully prepared using the optimized parameters of 800 psi, 7 cycles and 1.2 g lecithin. The IVLE prepared had a particle size of 252.60 ± 4.88 nm and was physically stable for 4 weeks at different storage temperatures. SoLE 20% had a high content of natural vitamin E, remained sterile and pyrogen free. It was also safe for intravenous administration and did not alter the blood lipid (p > 0.05) and liver enzymes profiles (p > 0.05) of the rabbits.
The optimal parameters to develop a stable superolein based IVLE are 800 psi homogenization pressure, 7 homogenization cycles and using 1.2 g lecithin as the emulsifier. SoLE 20% is safe for intravenous administration and does not significantly alter lipid and liver enzymes profiles of the rabbits.
静脉内脂肪乳剂（IVLE）最初用于预防必需脂肪酸缺乏症。含有α-生育酚的 IVLE 已被报道可预防肠外营养相关肝病。本研究旨在确定从超油棕榈油（SoLE20%）开发物理稳定的 IVLE 的最佳参数和条件，并在动物模型中研究其对脂质和肝脏谱的影响。
使用超油和 MCT 油（1:1）制备 SoLE20%，用卵磷酯稳定并使用高压匀浆机匀化。平均粒径用作响应变量，使用激光衍射和动态光散射法测量。根据粒径和分布、多分散指数、Zeta 电位、粘度、生育酚含量和 pH 值，确定在 4°C、25°C 和 40°C 储存温度下的物理稳定性。还研究了无菌性和热原性。给兔子注射 1.0g/kg SoLE20%，每天 1 次，连续 3 天，以研究其对血脂和肝酶谱的影响。
使用 800psi、7 个循环和 1.2g 卵磷酯的优化参数成功制备了 SoLE20%。制备的 IVLE 粒径为 252.60±4.88nm，在不同储存温度下 4 周内物理稳定。SoLE20%含有丰富的天然生育酚，无菌且无热原。它也可安全静脉注射，不会改变兔子的血脂（p>0.05）和肝酶谱（p>0.05）。
开发稳定的基于超油的 IVLE 的最佳参数为 800psi 匀浆压力、7 次匀浆循环和使用 1.2g 卵磷酯作为乳化剂。SoLE20%静脉内给药安全，不会显著改变兔子的脂质和肝酶谱。
