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童廷德, 黄蕊, 孙逊, 等. 丹酚酸B磷脂复合物自乳化药物传递系统的制备及质量评价[J]. koko体育app 学报（医学版）, 2013, 44(2): 303-307.
引用本文: 童廷德, 黄蕊, 孙逊, 等. 丹酚酸B磷脂混合物自乳化机药剂传承系统化的制法及产品质量考核[J]. 四川省大学时学报（医疗版）, 2013, 44(2): 303-307.
TONG Ting-de, HUANG Rui, SUN Xun, et al. Optimization and Characterization of SalB-PC Loaded Self-emulsifying Drug Delivery System[J]. Journal of Sichuan University (Medical Sciences), 2013, 44(2): 303-307.
Citation: TONG Ting-de, HUANG Rui, SUN Xun, et al. Optimization and Characterization of SalB-PC Loaded Self-emulsifying Drug Delivery System[J]. Journal of Sichuan University (Medical Sciences), 2013, 44(2): 303-307.

丹酚酸B磷脂复合物自乳化药物传递系统的制备及质量评价

Optimization and Characterization of SalB-PC Loaded Self-emulsifying Drug Delivery System

  • 摘要: 目的 制备丹酚酸B磷脂复合物(SalB-PC)自乳化药物传递系统(SEDDS),并对其进行质量评价。 方法 利用单因素筛选和伪三元相图法,根据乳化效率、乳化后样品的性状及其粒径等指标,筛选出最优处方,并对自乳化制剂的形态学、粒径和电位,以及在人工肠液中的释放特性等质量指标进行考察。 结果 最优处方:SalB-PC:Lauroglycol FCC:Cremophor EL:Transcutol P的质量比为9:45:40:15。SalB-PC自乳化制剂为黄色澄清液体,经过100倍稀释形成的乳剂粒径为(187.2±7.1)nm,多分散指数(PDI)为0.267±0.008,zeta电位为(-35.6±2.7)mV,在人工肠液中的释放速率比SalB溶液和SalB-PC溶液缓慢。 结论 水溶性药物丹酚酸B可以制备成自乳化给药系统,该剂型能减缓SalB在人工肠液中的释放速率。  
    Abstract: Objective To prepare self-emulsifying delivery system (SEDDS) of Salvianolic acid B phospholipid complex (SalB-PC) and evaluate its quality. Methods 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. Results 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. Conclusion 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.  
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