油包水型药用微乳的处方筛选及质量评价

目的:筛选水溶性药物油包水型药用微乳的处方及质量评价。方法:选用Volp-5为表面活性剂,短链醇类化合物作助表面活性剂及不同的油相,采用伪三元相图法筛选处方组成及其质量比,考察组分、温度、添加剂等对微乳区的影响以及微乳的稳定性。结果:以适当的基质配比制得了稳定的微乳。油包水型药用微乳处方为Volp-5/乙醇/辛酸癸酸甘油酯/水(3∶2∶2∶4)。结论:油包水型微乳可作为水溶性药物新剂型载体,其质量稳定,易于制备。

Formulation of Water-in-oil Microemulsion and Its Quality Evaluation

OBJECTIVE:To select the formula,preparation and quality evaluation of water-in-oil microemulsion. METHODS:Water-in-oil micromulsion has been formulated using Volp-5 as surfactant, several short chain alcohols as co-surfactants, and the different oils, pseudoternary phase diagrams have been constructed to evaluate the phase behavior of the formulations of the water-in-oil microemulsion, and the influence of mixing ratio of various elements on the area of microemulsion was also examined. The morphology, particle size, distribution and stability was assessed. RESULTS:The stable water-in-oil microemulsion was made. The microemulsion delivery could be prepared using Volp-5/ethanol/caprylic-capric-triglyceride/water (3∶2∶2∶4)system and no phase separation was observed in three months. CONCLUSION:The formulation provide a convenient means of the oral delivery taking advantage of microemulsion's merit, which is easy to prepare with consistent quality.