复方彻清膏微乳的制备及稳定性研究

Preparation and stability of Compound Cheqinggao microemulsion

目的制备复方彻清膏微乳,并考察其稳定性。方法通过溶解度实验结合单因素考察绘制伪三元相图,筛选处方组成,再以乳化剂、油相和助乳化剂的质量分数为自变量,以微乳粒径和载药量为响应值,采用Box-Behnken设计-效应面法优化处方,并对其稳定性进行考察。结果复方彻清膏微乳的最优处方为聚氧乙烯氢化蓖麻油(RH40)-聚乙二醇400(PEG400)-肉豆蔻酸异丙酯(IPM)-水(0.33∶0.16∶0.16∶0.35),平均载药量为224.17 mg/mL,平均粒径为56.50 nm,在4℃和25℃避光条件下稳定性良好。结论制备得复方彻清膏微乳外观性状良好,载药量高,粒径小,稳定性较好,可明显增加彻清膏挥发油的溶解度。

Objective To optimize the composition of Compound Cheqinggao microemulsion and investigate its stability. Methods Suitable emulsifier, co-emulsifier, and oil phase were selected by solubility method, and the pseudo ternary phase diagram was drawing by water titration. Then, the factors with the mass fraction of emulsifier, co-emulsifier, and oil phase as the independent variables, and the drug loading and particle size as response value, using Box-Behnken design-response surface method to determine the best prescription ratio and investigate its stability. Results The optimal composition of substrate from Compound Cheqinggao microemulsion was as follows： 33% of polyoxyethylene hychogenated castor oil（RH40）, 16% of polyethylene glycol（PGE400）, 16% of Isopropyl palmitate, and 35% of water. Under these conditions, drug loading was 224.17 mg/mL and the particle size was 56.50 nm. Compound Cheqinggao microemulsion has good stability at 4 ℃ and 25 ℃ in dark conditions. Conclusion The prepared microemulsion has good appearance, high drug loading, suitable particle size, and good stability, which could greatly increase the solubility of Compound Cheqinggao volatile oil.