目的 制备山柰Kaempferia galanga挥发油自微乳化固体颗粒，优化其工艺，并对其质量进行评价。方法 通过溶解度考察和伪三元相图优选出制备山柰挥发油自微乳的辅料及其质量比范围；采用星点设计-响应面法建立模型并验证，优化自微乳处方；对自微乳颗粒进行结构表征，并进行体外溶出度实验，对其质量进行评价。结果 山柰挥发油自微乳最佳配方为油相占比29.04%，乳化剂占比59.13%，助乳化剂占比11.82%，以甘露醇和蔗糖3∶1为固体吸附剂，制备得到的山柰挥发油自微乳颗粒外观圆整，无黏连，微乳类型为水包油型（O/W），自乳化平均用时（37.02±2.95）s，粒径大小分布均匀，平均粒径为（89.11±1.74）nm，分散系数PDI值为0.252±0.090，ζ电位为（−11.71±1.23）mV。颗粒在室温下密封储存30 d，粒径和含量无明显变化，其胶囊在30 min可释放90%以上药物。结论 所制备的山柰挥发油自微乳化颗粒外观圆整，自乳化效率高，微乳粒径分布均匀，有良好的体外释放性和稳定性。

Objective To prepare Kaempferia galanga volatile oil self-microemulsion solids, optimize its process, and evaluate its quality. Methods Solubility investigation and pseudo ternary phase diagram were applied to screen the excipients and their mass ratio range for preparing volatile oil self-microemulsion of K. galanga. Then, using central composite design-response surface methodology to establish the model and validate it to optimize the formulation of self-microemulsion. Lastly, the structure of the self-microemulsion solids prepared under the optimized formulation was characterized, and in vitro dissolution experiments were conducted, in order to evaluate its quality. Results The optimum formula of volatile oil self-microemulsion of K. galanga was oil phase of 29.04%, emulsifier of 59.13% and co-emulsifier of 11.82%. The volatile oil self-microemulsion solids of K. galanga were prepared by using mannitol and sucrose as solid adsorbent with mass ratio of 3:1. The particles were rounded in appearance and non-adhesive, the microemulsion was oil in water (O/W), the average self-emulsifying time was (37.02 ± 2.95) s, the average particle size was (89.11 ± 1.74) nm, the dispersion coefficient of PDI was 0.252 ± 0.090, and the ζ potential was (−11.71 ± 1.23) mV. The pellets were stored for 30 d at room temperature in a sealed container with no significant change in particle size or content, and the capsules released more than 90% of the drug in 30 min. Conclusion The prepared K. galanga volatile oil self-microemulsion solids have a round appearance, high self-emulsification efficiency, uniform particle size distribution, and good in vitro release and stability.

R283.6

全国中医药创新骨干人才培养项目（国家中医药管理局）［国中医药人教函（2019）128号］