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作 者:张翠霞[1] 王东凯[1] 王海凤[1] 宋涛[1] 张勖[2]
机构地区:[1]沈阳药科大学,沈阳110015 [2]沈阳沃森药物研究所,沈阳110015
出 处:《中国新药杂志》2006年第15期1264-1267,共4页Chinese Journal of New Drugs
摘 要:目的:制备尼莫地平亚微乳并对其性质进行考察。方法:本实验通过正交试验设计优选了尼莫地平亚微乳的最佳处方及制备工艺,并通过粒径测定、ζ电位的测定、包封率的测定和稳定性的考察等研究了尼莫地平亚微乳的性质。结果:尼莫地平亚微乳的最佳处方工艺组合为磷脂与泊洛沙姆188的比例为2:1(w:w),高速剪切乳化时间为5 min,制备温度为70℃。所制备的乳剂包封率为97.9%,ζ电位为-30.6mV,平均粒径为137 nm。稳定性考察表明该乳剂在常温及加速3个月条件下均较稳定。结论:本实验制备的尼莫地平亚微乳粒度分布范围窄,稳定性较好,包封率较高。Objective: To characterize nimodipine submicroemulsion newly developed. Methods:The formulation and preparation procedure of nimodipine submicroemulsion were optimized by orthogonal experiments. The nimodipine submicroemulsion were characterized based on stability and the determination of its particle size, ζ potential and entrapment efficiency. Results:The most optimal formulation and preparation procedure were as follows : ratio of soybean phospholipids and poloxamer 188 in 2: 1, high speed shearing emulsification time at 5 min, preparation temperature at 70 ℃, entrapment efficiency of nimodipine submicroemulsion of 97.9% , a ζ potential of -30. 6 mV and a mean particle size of 137 nm. The stability study showed that the submicroemulsion was stable at 40 ℃ and room temperature for 3 months. Conclusion:A stable nimodipine submicroemulsion is attainable.
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