中国药物警戒 ›› 2016, Vol. 13 ›› Issue (7): 398-402.

• 质量与工艺研究 • 上一篇    下一篇

蛇床子素-聚乙二醇6000固体分散体的制备与性质研究

俞迪佳1, 刘扬2, 朱缨1   

  1. 1 苏州卫生职业技术学院，江苏 苏州 215009;
    2 苏州大学药学院，江苏 苏州 215123
  • 收稿日期:2016-06-20 修回日期:2018-07-17 出版日期:2016-07-20 发布日期:2018-07-17
  • 作者简介:俞迪佳，女，硕士，讲师，药物制剂新剂型与新工艺。

Study on Preparation and Properties of Osthole-polyethyleneglycol 6000 Solid Dispersion

YU Di-jia1, LIU Yang2, ZHU Ying1   

  1. 1Suzhou Health College, Jiangsu Suzhou 215009, China;
    2College of Pharmaceutical Sciences, Soochow University, Jiangsu Suzhou 215123, China
  • Received:2016-06-20 Revised:2018-07-17 Online:2016-07-20 Published:2018-07-17

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摘要： 目的 制备蛇床子素-PEG6000固体分散体，提高体外溶出度，以提升生物利用度。方法 结合表观溶解度、溶出度和差示热量扫描（DSC）图谱，筛选蛇床子素-PEG6000固体分散体制备方法和药载比。并采用差式扫描量热（DSC）、扫描电镜（SEM）鉴别药物在固体分散体中的存在状态。结果 选用熔融法制备固体分散体，固体分散体中药物和载体的比例为1:4。制备而得的固体分散体60 min累积溶出度89.2%，远高于原料药56.2%。药物与载体形成了低共熔物，药物以分子或无定型的形式存在于固体分散体中。结论 用熔融法制备的药载比为1:4的蛇床子素-PEG6000固体分散体体外溶出度高于蛇床子素原料药。

关键词: 蛇床子素, 固体分散体, 聚乙二醇6000

Abstract: Objective To prepare osthole-PEG6000 solid dispersion in order to improve osthole dissolution rate in vitro and also improve its bioavailability. Methods The preparation methods of osthole-PEG6000 solid dispersion and the ratio of drug were screened by apparent solubility，dissolution rate and differential scanning calorimetry (DSC) spectra.The state of osthole in carrier of osthole -PEG6000 solid dispersion was further determined by using differential scanning calorimetry (DSC) and scanning electron micrograph (SEM). Results The osthole -PEG6000 solid dispersion which was prepared by melting method（the ratio of the drug to PEG6000 was 1:4）showed 60 min dissolution rate of 89.2% was far higher than osthle 60 min dissolution rate of 56.2%. The drug and carrier form a eutectic in solid dispersion and the majority of osthole existed in solid dispersion as amorphous forms or molecular state. Conclusion The dissolution rate in vitro of osthole -PEG6000 solid dispersion which was prepared by melting method（the ratio of the drug to PEG6000 was 1:4）is higher than the dissolution rate in vitro of osthole.

Key words: osthole, solid dispersion, PEG6000

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