Tong Ting-De, Huang Rui, Sun Xun, Zhang Yan, Gong Tao, Zhang Zhi-Rong
Key Laboratory of Drug Targeting and Novel Delivery Systems, Ministry of Education, West China School of Pharmacy, Sichuan University, Chengdu 610041, China.
Sichuan Da Xue Xue Bao Yi Xue Ban. 2013 Mar;44(2):303-7.
To prepare self-emulsifying delivery system (SEDDS) of Salvianolic acid B phospholipid complex (SalB-PC) and evaluate its quality.
The best formulation was optimized using single-factor and pseudo-ternary phase diagrams, according to the emulsifying efficiency, the characteristics and partical size of the emulsion and other indicators. The morphology, particle size, zeta-potential and the release in artificial intestinal fluid of self-emulsifying formulation were evaluated.
The weight ratio of SalB-PC: Lauroglycol FCC:Cremophor EL:Transcutol P in the best formulation was 9:45:40:15. SalB-PC loaded self-emulsifying formulation is yellow and transparent solution, with partical size about (187.2 +/- 7.1) nm, polydispersity index (PDI) about 0.267 +/- 0.008 and zeta-potential about (-35.6 +/- 2.7) mV after diluted about 100-fold. The self-emulsifying formulation released slower than the solution with only SalB or SalB-PC.
Water-soluble drug Salvianolic acid B can be prepared to SEDDS, and this formulation can slow down the release of SalB in artificial intestinal fluid.
制备丹酚酸B磷脂复合物（SalB-PC）的自乳化给药系统（SEDDS）并评价其质量。
根据乳化效率、乳液的特性和粒径等指标，采用单因素法和伪三元相图优化最佳处方。对自乳化制剂的形态、粒径、ζ电位及在人工肠液中的释放情况进行评价。
最佳处方中SalB-PC:月桂二醇FCC:聚氧乙烯蓖麻油EL:二甲基亚砜的重量比为9:45:40:15。载SalB-PC的自乳化制剂为黄色透明溶液，稀释约100倍后粒径约为（187.2±7.1）nm，多分散指数（PDI）约为0.267±0.008，ζ电位约为（-35.6±2.7）mV。自乳化制剂的释放比仅含SalB或SalB-PC的溶液慢。
水溶性药物丹酚酸B可制备成SEDDS，该制剂可延缓SalB在人工肠液中的释放。
