柚皮苷微乳制备工艺研究

Preparation Technology of Naringin Microemulsion

目的建立柚皮苷微乳的处方与制备工艺。方法以溶解度为指标筛选柚皮苷微乳油相,通过表面活性剂与助表面活性剂配伍试验与伪三元相图法筛选柚皮苷微乳处方;以微乳外观、透光率为指标,对微乳的乳化温度和稀释倍数进行筛选;对制备的柚皮苷微乳进行外观、形态和粒径表征观察;通过高温试验和常温留样试验对柚皮苷微乳进行初步稳定性考察。结果柚皮苷微乳最佳处方组成比例为柚皮苷2%,油酸乙酯4%,聚氧乙烯35蓖麻油12%,无水乙醇4%,水78%;柚皮苷微乳的最佳乳化温度为40℃,稀释倍数为20倍;柚皮苷微乳的外观性状为黄棕色透明,呈圆球形,pH为5.37,粒径在10~100 nm;柚皮苷微乳于60℃放置5 d外观明显浑浊,于25℃放置6个月质量稳定。结论该方法制备的柚皮苷微乳符合要求,可为柚皮苷制剂的后期研究提供参考。

Objective To establish the formulation and preparation technology of naringin microemulsion.Methods The naringin microemulsion oil phase was screened with the solubility as the index,the naringin microemulsion formula was screened by the surfactant and co-surfactant compatibility test and the pseudo-ternary phase diagram method.The microemulsion appearance and light transmittance were used as indicators to screen the emulsification temperature and dilution factor of the microemulsion and to characterize the appearance,morphology and particle size of the prepared naringin microemulsion.The stability of naringin microemulsion was preliminarily investigated by high-temperature test and normal temperature retention test.Results The optimal prescription composition ratio of naringin microemulsion was naringin(2%),ethyl oleate(4%),polyoxyethylene 35 castor oil(12%),absolute ethanol(4%),and water(78%),the optimal emulsification temperature of naringin microemulsion was 40℃,and the dilution factor was 20 times.Naringin microemulsion was yellowish-brown and transparent,with a spherical shape,its pH was 5.37 and its particle size was 10-100 nm.The naringin microemulsion has become cloudy after being stored at 60℃for 5 d,but its quality was stable after being stored at 25℃for 6 months.Conclusion Naringin microemulsion prepared by this method can meet the requirements,which can provide a reference for the later research of naringin preparations.