电导率-伪三元相图法优选玉红膏纳米乳处方

目的:优选玉红膏纳米乳的处方,为改善该制剂的质量稳定性提供参考。方法:在恒温磁力搅拌下,改变体系的组成,观察电导率变化,利用二次回归模型确定相变临界点,通过制作经典三元相图筛选玉红膏纳米乳的最佳处方。结果:最佳处方为选择亲水亲油平衡值11.26的混合乳化剂,乳化剂-助乳化剂(2.603∶1),甘油-无水乙醇(3∶1)的混合物为助乳化剂,精制芝麻油为油相,娃哈哈纯净水为水相,油相-水相-混合乳化剂(28.99∶63.74∶7.27)。结论:优选的处方工艺简单、载药量高,适用于提高玉红膏的质量稳定性。

Optimization of Formula of Yuhong Nanoemusion by Conductivity-pseudo-ternary Phase Diagram

Objective: To optimize formula of Yuhong nanoemulsion and provide a reference for improving of quality stability of this preparation. Method: When composition of nanoemulsion changed, conductivity change was observed on the basis of magnetic stirring at a constant temperature, quadratic regression model was adopted to determine critical points of phase transition, then formula of Yuhong nanoemulsion was optimized by making classic ternary phase diagram. Result: Optimum formula was as following:mixed emulsifier with hydrophilic-lipophilic balance value of 11.26, ratio of emulsifier and co-emulsifier 2.603:1, with mixture of glycerol-ethanol(3:1) as a co-emulsifier, refined sesame oil as oil phase, Wahaha purified water as water phase, oil phase-water phase-mixed emulsifier(28.99:63.74:7.27). Conclusion: This optimized formula is stable and feasible with higher drug-loading, it is suitable for improving stability of Yuhong ointments.