曲克芦丁微乳的处方筛选及含量测定

Formulation Screening and Determination of Troxerutin Microemulsion

目的筛选亲水性药物曲克芦丁油包水型口服微乳的最佳处方,考察其形态、粒径大小、稳定性,并建立其含量测定方法。方法利用伪三元相图,以微乳形成区域大小为指标,筛选制备微乳的最佳处方。采用高效液相色谱法测定微乳中药物含量。结果筛选出的最佳处方是大豆磷脂/无水乙醇/肉豆蔻酸异丙酯/纯化水=23.30∶11.67∶52.45∶12.59。所制得的微乳外观圆整,大小分布均匀,平均粒径为50.20 nm,具有良好稳定性。结论大豆磷脂/无水乙醇/肉豆蔻酸异丙酯/纯化水体系将曲克芦丁成功包载于水相,有望为曲克芦丁口服给药提供一种有效的新剂型。

Objective To optimize a W / O microemulsion formulation of troxerutin and evaluate its physical properties such as morphology,droplet size,stability and content of troxerutin. Methods The W / O microemulsion was optimized using a pseudoternary phase diagram and the area of the microemulsion region was used to screen and determine microemulsion components.HPLC assay was used for determination of the loading content. Results The optimal formulation contained lecithin,ethanol,isopropyl myristate and water（ 23. 30 ∶ 11. 67 ∶ 52. 45 ∶ 12. 59）. The microemulsion was physicochemically stable with round shape and uniform size,and the mean droplet size was about 50. 20 nm. Conclusion Microemulsion was developed successfully.It will expect to be the new preparation for troxerutin.