目的 探讨制备雷公藤内酯醇纳米脂质体（TP-NLS）涂膜剂的最佳处方及工艺。方法 以聚乙烯醇124（PVA124）、单硬脂酸甘油酯、甘油等基质材料的用量及搅拌时间为考察因素，以均匀性、成膜性、剥离程度为考察指标，采用U₇(7⁴)均匀设计法优选TP-NLS涂膜剂的制备处方及工艺。以最佳工艺制备的涂膜剂进行体外模拟透皮实验，考察TP-NLS涂膜剂的经皮渗透过程。结果 制备30 g TP-NLS涂膜剂的最佳处方及工艺为单硬脂酸甘油酯1.6 g、甘油0.25 g、PVA124 3.9 g、卡波姆0.6 g、CMC-Na 0.9 g，搅拌150 min。按该工艺制备的TP-NLS涂膜剂体外经皮渗透速率（J_s）为0.350 μg/(cm²·h)，24 h累积渗透量（Q_{24 h}）为11.534 μg/cm²。结论 按最佳制备工艺制备的TP-NLS涂膜剂均匀，易涂布，成膜时间短，膜剂成型后与皮肤的黏附性好，柔韧性强。药物经皮渗透速率快，24 h累积渗透量增大。

Objective To explore the optimum preparation process of triptolide nanometer coating agent. Methods Optimum preparation process was investigated by uniform design with the amount of film forming material such as polyethylene glycol 124 (PVA124), carbomer, CMC-Na, and the mixing time as investigating factors, and with uniformity, film-forming ability, and peeling strength as indexes. We conducted sc simulation experiment in vitro to investigate the percutaneous penetration process of triptolide nanometer coating agent. Results The best way to prepare triptolide nanometer coating agent is that we use glycerol monostearate 1.6 g, glycerin 0.25 g, PVA124 3.9 g, Carbomer 0.6 g, CMC-Na 0.9 g, and mix them in 150 min. With above preparation process, we can achieve better coating agent. J_S was 0.350 μg/(cm²·h) and the cumulative permeation quantity in 24 h was 11.534 μg/cm². Conclusion Using the optimum preparation process, we can get better triptolide nanometer coating agent, which is uniform, easy coating,good adhesion with skin, strong flexibility, and drying soon.

国家卫生与计划生育委员会科研基金课题（WKJ-FJ-15）；福建省省属公益类科研院所基本科研专项（2015R1031-4；2016R1029-3）；福建省科技计划社会发展引导性（重点）项目（2014Y0051）；福建省卫生厅中医药科研项目（wzze201306）