高载药量鼻用丹参酮Ⅱ_A亚微乳制备工艺研究  

A study on preparation of high drug-loading Tanshinone Ⅱ_A nasal submicron emulsion

作　　者：张岁玲[1] 郭琳[2] 史亚军[1] 梁玉琳[1] 王瑜[1] 

机构地区：[1]陕西中医药大学,咸阳712046 [2]陕西中医药大学第二附属医院,咸阳712000

出　　处：《陕西中医》2017年第9期1298-1300,共3页Shaanxi Journal of Traditional Chinese Medicine

基　　金：陕西省教育厅科研计划项目(15JK1202);陕西中医药大学科研创新基金项目(14XJZR01)

摘　　要：目的:采用独特的转相技术制备高载药量鼻用丹参酮Ⅱ_A亚微乳制剂。方法:将丹参酮Ⅱ_A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Ⅱ_A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400bar,均质时间为16min,温度为35℃。最终制备得到载药量0.5%的丹参酮Ⅱ_A亚微乳,平均粒径为221nm,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 Ⅱ_A nasal submicron emulsion.Method:Dissolve Tanshinone Ⅱ_Ain 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 Ⅱ_A 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 was0.5 %,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 Ⅱ_Asubmicron 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.

关 键 词：丹参酮Ⅱ_A 鼻用制剂 中药制药工艺 

分 类 号：R28[医药卫生—中药学]