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目的:采用独特的转相技术制备高载药量鼻用丹参酮IIA亚微乳制剂.方法:将丹参酮IIA溶解于无水乙醇,将此溶液置于圆底烧瓶中,加入大豆油与中链油,减压回收体系中的无水乙醇至完全,待丹参酮IIA全部转移至油相中,采用高压均质法制备亚微乳,采用正交试验法进行处方优化,并考察了高压均质条件,乳化剂 、稳定剂的用量.结果:处方优化的最佳条件:载药量为0.5 ％,乳化剂S-75用量为3 ％,F-68用量为1 ％,油酸用量为0.2 ％.制备工艺的最佳条件:均质压力为400 bar,均质时间为16 min,温度为35℃.最终制备得到载药量0.5 ％的丹参酮IIA亚微乳,平均粒径为221 nm,稳定性良好.结论:确定的制备工艺稳定可行,载药量较传统方法高,能够满足该药物多途径给药要求.“,”Objective: The unique phase inversion technique was adopted to prepare high drug-loading Tanshinone IIA nasal submicron emulsion.Method: Dissolve Tanshinone IIA in anhydrous ethanol, and transfer the above solution into the round-bottomed flask.After adding soybean oil and oil, recover the entire ethanol of the system under vacuum condition.Until the Tanshinone IIA transferred to the oil phase completely , submicron emulsion was prepared by the use of the high pressure homogenization method.Orthogonal design was used to optimize the prescription and preparation techniques with the high pressure homogenization conditions as well as the dosages of emulsifier and stabilizer investigated.Results: The optimum conditions were as follows: the amount of drug loading was 0.5 ％, and the amount of S-75 was used as emulsifier 3 ％,F-68 was 1 ％, and the amount of oleic acid was 0.2 ％.The best conditions for the preparation process: the homogeneous pressure is 400 bar, the homogenization time was 16 min and the temperature was 35 ℃.The Tanshinone IIA submicron emulsion in preparation had a good stability with drug-loading 0.5 ％ and the average particle size 221 nm.Conclusion: The optimized technology in this experiment is stable and feasible.And the higher drug-loading than conventional methods can satisfy the requirement of different administration routes.