【摘要】 目的 以筋骨止痛凝胶川芎、防风、花椒混合挥发油制备稳定好的自微乳。方法 通过原辅料相溶性考察、乳化外观等级及伪三元相图法筛选自微乳的初步配方；采用D-最优混料设计，以平均粒径，PDI，乳化外观为评价指标，对初步配方进行配比优化得最优处方；并以粒径、Zeta电位、载药量，稳定性等试验对其进行质量评价。结果 制得中药混合挥发油自微乳为淡黄色透明溶液，其最优处方为挥发油占56%，吐温80占26%、无水乙醇占18%，平均粒径为（105.06±0.90） nm,PDI为（0.248±0.100）,Zeta电位值为（-7.98±0.30） mV。通过稳定性考察得出混合挥发油自微乳在高速离心、长时间静置、不同稀释倍数、不同介质下均未出现分层。结论 首次将自微乳技术应用于中药复方凝胶剂混合挥发油制备，且稳定性好，可为中药经皮给药制剂中挥发油研究提供借鉴。更多还原

【Abstract】 Objective To prepare self-microemulsifying drug delivery system(SMEDDS) of mixed volatile oil of Rhizoma Chuanxiong, Radix Saposhnikoviae and Pericarpium Zanthoxyli from Jingu Zhitong Gel （筋骨止痛凝胶, JGZTG）.Methods The preliminary formula of SMEDDS was selected through investigation of solubility of raw and auxiliary materials, the emulsification appearance grade and the drawing of pseudo-ternary phase diagram; D-optimal mixture design was used to optimize the preliminary formula with average particle size, PDI, and emulsification appearance as indices, obtaining the optimal formulation; Quality was evaluated by particle size, Zeta potential, drug loading, and stability.Results SMEDDS is a light yellow transparent solution. The best prescription is volatile oil 56%, Tween 80 26%, anhydrous ethanol 18%, with an average particle size of 105. 06±0. 90 nm, PDI of 0. 248±0. 100, and Zeta potential of-7. 98±0. 30 mV. Through the stability investigation, SMEDDS showed no stratification after high-speed centrifugation, long-term standing, under different dilution multiples, and in different media.Conclusion Self-microemulsion technology was first applied to the preparation of TCM compound gel mixed volatile oil with good stability, which can provide reference for the study of volatile oil in percutaneous preparations of TCM.更多还原