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水飞蓟素自微乳的研制

Silymarin self-microemulsifying drug delivery systems (SMEDDS)

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【作者】 刘琳婕逄秀娟张伟高雪峰段江瑛王思玲

【Author】 LIU Lin-jie,PANG Xiu-juan,ZHANG Wei,GAO Xue-feng,DUAN Jiang-yin,WANG Si-ling (School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

【机构】 沈阳药科大学药学院沈阳药科大学药学院 辽宁沈阳110016辽宁沈阳110016

【摘要】 目的筛选水飞蓟素自微乳的处方并对其体外溶出及稳定性进行考察。方法通过溶解度实验、正交设计及伪三元相图的建立,筛选水飞蓟素自微乳的组成。采用HPLC法测定处方中的药物含量,并对照市售制剂考察其溶出度及稳定性。结果水飞蓟素自微乳化系统的组成为水飞蓟素、油酸乙酯、聚氧乙烯氢化蓖麻油(Cremophor EL)和乙二醇单乙基醚(transcutol)的质量比为0.07∶0.45∶0.45∶0.1;自微乳的平均粒径为72.1 nm;于4种溶出介质中均完全溶出,且溶出曲线明显高于市售制剂;强光照射(4 500 lx)、高温(60℃)及高低温循环实验(40℃和4℃)结果表明,该自微乳性状、含量均无明显变化。结论水飞蓟素自微乳粒径小,溶出度及稳定性良好。

【Abstract】 Objective To design the formulation for silymarin self-emulsifying microemulsion and evaluate its dissolution and stability.Methods The formulation was established through solubility experiments,orthogonal design and pseudo-ternary phase diagrams.The dissolution and stability were evaluated by HPLC assay.Results The optimal formulation was composed of silymarin,ethyl oleate,Cremophor EL and transcutol,with the ratio of 0.07∶0.45∶0.45∶0.1.The average particle size was 72.1 nm.Silymarin from SMEDDS was completely and rapidly dissolved in four different buffer media and obtained a higher dissolution profile compared with commercial preparations.The appearance and average silybin content of SM-SMEDDS were of no significant changes after 10 days of illumination(4 500 lx),high temperature(60 ℃) and temperature cycling tests(40 ℃,4 ℃).Conclusions The acquired microemulsion is stable,with small particle size and good dissolution.

  • 【文献出处】 沈阳药科大学学报 ,Journal of Shenyang Pharmaceutical University , 编辑部邮箱 ,2007年09期
  • 【分类号】TQ461
  • 【被引频次】12
  • 【下载频次】596
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