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| 丹酚酸B口服微乳的处方设计及含量测定 |
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马丽1,2, 刘志东1,2, 李楠1,2, 孙精通1,2, 张倩1,2, 叶丽娜3
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1.天津中医药大学, 天津市现代中药重点实验室-省部共建国家重点实验室培育基地, 天津 300193;2.天津中医药大学, 现代中药发现与制剂技术教育部工程研究中心, 天津 300193;3.天津中医药大学中药学院, 天津 300193
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| 摘要: |
| [目的] 确定亲水性药物丹酚酸B(Sal B)油包水(W/O)口服微乳的最佳处方及含量测定方法。[方法] Km值(Km=m乳化剂:m助乳化剂)滴定法制备伪三元相图, 考察表面活性剂、助表面活性剂、油相种类, 药物, Km值, 温度对微乳区域面积的影响, 筛选出W/O型微乳的最佳处方组合。高效液相色谱(HPLC)法测定其含量。[结果] 微乳区域面积较大的微乳处方组合为Labrafil M 1944CS/大豆卵磷脂(PC)/无水乙醇/Sal B溶液(45 mg/mL)(Km=1),制备温度为(40±1)℃。[结论] 最优处方可成功的将Sal B包载于水相, 得到澄清透明, 流动性好的均相体系。 |
| 关键词: 丹酚酸B W/O型微乳 伪三元相图 |
| DOI：10.11656/j.issn.1672-1519.2013.02.16 |
| 分类号: |
| 基金项目:国家自然科学基金项目(81001645). |
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| Prescription designing and content determination of Salvianolic acid B oral microemulsion |
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MA Li1,2, LIU Zhi-dong1,2, LI Nan1,2, SUN Jing-tong1,2, ZHANG Qian1,2, YE Li-na3
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1.Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of TCM, Tianjin 300193, China;2.Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Tianjin University of TCM, Tianjin 300193, China;3.College of TCM, Tianjin University of TCM, Tianjin 300193, China
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| Abstract: |
| [Objective] To identify the best prescription and the content determination method of the oral micro-emulsion of the hydrophilic Salvianolic acid B (Sal B) in type of water in oil (W/O). [Methods] A pseudo three dimensional phase diagram was prepared by Km value titration to investigate the influence of surfactant, cosurfactant, oil phase types, drug, Km value, temperature on the microemulsion area and select the best prescription combination of W/O microemulsion. Its content was determined by HPLC method. [Results] The microemulsion prescription with larger region was Labrafil M 1944CS/soybean lecithin (PC)/dehydrated alcohol/Sal B solution (45 mg/ml) (Km=1). The temperature for the preparation was (40±1)℃. [Conclusion] The optimal prescription can entrap Sal B in the aqueous phase, obtaining the homogeneous system of clear transparent and good fluidity. |
| Key words: Salvianolic acid B W/O microemulsion pseudo three dimensional diagram |
