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正交实验法优化紫草素类脂囊泡的处方工艺

Optimization of formulation and preparation process of shikonin noisomes by orthogonal design

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【作者】 诸葛瑞娇尹言明闫海霞王莎莎曲晓兰王建筑

【Author】 ZHUGE Ruijiao;YIN Yanming;YAN Haixia;WANG Shasha;QU Xiaolan;WANG Jianzhu;College of Pharmacy,Taishan Medical University;

【机构】 泰山医学院药学院

【摘要】 目的优选紫草素类脂囊泡的处方工艺。方法采用薄膜分散法制备紫草素类脂囊泡,以紫草素与司盘60的质量比、司盘60与胆固醇的用量比、磷酸盐缓冲液的用量以及水化时间作为考察因素,将包封率作为考察指标,进行正交实验优化制备工艺。用HPLC法测定包封率,用显微镜观察类脂囊泡的外观形态,并用粒径测定仪测定类脂囊泡的粒径。结果最佳制备工艺为:紫草素与司盘60的比例为1∶20;司盘60与胆固醇的比例为1∶1;磷酸盐缓冲液的用量为15mL;水化时间为30min。所得类脂囊泡的包封率为81.6%;形态为粒径均匀的球形和类球形,粒径为387.6nm,多分散指数PDI为0.476。结论该制备工艺稳定、可行、重复性好,可为工业化生产提供理论依据。

【Abstract】 Objective To optimize the preparation technology of shikonin noisomes.Methods The shikonin noisomes were prepared by thin film hydrolysation method.The preparation was optimized by orthogonal design with encapsulation co-efficiency as index using the ratio of shikonin to Span-60,the ratio of Span-60 to cholesterol,the dosage of phosphate cushion fluid and the time of hydration as factors.The encapsulation efficiency was detected by HPLC.The morphological examination of shikonin noisomes was performed using microscopy.The particle size of the noisomse was measured.Results The ideal preparation parameters were as follows:the ratio of shikonin to Span-60 was 1∶20,the ratio of Span-60 to cholesterol was 1∶1,the dosage of phosphate cushion fluid was 15 mL and the time of hydration was 30 min.The noisomes with spherical or ellipsoidal shape and better stability featured the encapsulation efficiency of 81.6%,the mean particle size of 387.6nm,and the PDI of 0.476.Conclusion The preparation technology is feasible,stable and reproducible and could be used in industrial production.

【基金】 山东省中医药管理局发展计划项目(编号:2013255);泰安市科技发展计划项目(编号:201440774-16);国家级大学生创新创业训练计划项目(编号:201410439029)
  • 【文献出处】 西北药学杂志 ,Northwest Pharmaceutical Journal , 编辑部邮箱 ,2017年02期
  • 【分类号】R283.6
  • 【被引频次】4
  • 【下载频次】200
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