莪术挥发油亚微乳剂的制备与物理稳定性的研究

Study on Preparation and Physical Stability of Submicron Emulsion of Oleum curcumae Extracted from Rhizoma curcumae Royle

目的:研究莪术挥发油亚微乳剂的处方和制备工艺,并对其物理稳定性进行考察.方法:以平均粒径、粒度分布、ζ-电位等参数为指标,采用不同的蒸汽灭菌参数研究确定乳剂的分散相、稳定剂、复合乳化剂等处方组成.结果:所研制的莪术挥发油亚微乳剂载药量高,可耐受热压灭菌,室温下放置6个月基本稳定.其处方为:莪术油2.0%、大豆油2.0%、精制蛋黄磷脂1.2%、油酸0.04%、泊洛沙姆188 0.8%、注射用水加至100 mL.结论:莪术油含有挥发性活性成分,应根据挥发油的挥发特性,设计并制备稳定的可静脉注射的亚微乳剂.

Aim ： The preparation and physical stability of submicron emulsion of Oleum curcumae oil extracted from Rhizoma curcumae Royle is focused on. Methods ： Dispersed phase, stabilizer and co-surfactant of submicron emulsion are identified and studied by applying multiple parameters of steam sterilization according to mean droplet size, particle size distribution and zeta potential. Results ： Submicron emulsion of Oleum curcumae oil possesses high load capacity of drug and can keep stability under high-temperature and pressure sterilization. The emulsion can be kept stable under room temperature for 6 months. A typical formulation is ： Oleum curcumae oil 2.0% ; purified soybean oil 2.0% ; purified eeg yolk phospholipids 1.2% ; purified oleic acid 0. 04% ; poloxamer188 0.8% ; bidistilled water to 100 mL. Conclusion： Oleum curcumae oil contains many volatile components, stable submicron emulsion available for veinal injection could be prepared according to volatility of different components.