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氨二乙脂体配方:适用的制备方法,挑战和技巧

Rogayeh Seify1, Fahimeh Zahednezhad1, Parvin Zakeri-Milani2

  • 1Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran.

Drug development and industrial pharmacy
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概括

这项研究评估了三种方法来制备Amphotericin B (AmB) 脂质体,发现无溶剂的方法是最经济和环保的. 由此产生的脂质体表现出有利的特性和稳定性,适用于潜在的工业制造.

关键词:
氨基氨酸B (Amphotericin B) 是一种氨基氨酸.脂质细胞体中的脂肪体.可以注射的配方.纳米颗粒是一种纳米粒子.脂酸是一种脂酸.

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科学领域:

  • 制药科学 制药科学
  • 药物输送系统 药物输送系统
  • 纳米技术纳米技术

背景情况:

  • 氨酸B (AmB) 是一种具有显著毒性的关键抗真菌剂.
  • 脂质体配方提供了一种策略,通过改变AmB的药理动力学和毒性概况来改善AmB的治疗指数.
  • 开发稳定和可扩展的脂质体AmB配方对于其更广泛的临床应用至关重要.

研究的目的:

  • 探索和评估最优的方法来制备安福特素B (AmB) 脂质体.
  • 评估使用不同方法制备的AmB载荷脂质体的物理化学特性和稳定性.
  • 提供适合工业制造的预制剂,具有改善的性能和降低的毒性.

主要方法:

  • 溶解性选和三种脂质体制备技术:乙醇注射,溶剂蒸发和无溶剂方法.
  • 脂质体的特征,包括大小,大小分布,泽塔潜力 (ZP),形态,药物负载和负载能力.
  • 物理化学稳定性研究和药物脂质相互作用分析,使用HPLC量化AmB.

主要成果:

  • 这三种方法都产生了具有可接受特性的AmB载荷脂质体 (尺寸:150.3263.9nm,PDI ≤0.32).
  • 脂质体是球形和分离的,具有物理药物负载,没有显著的药物脂质相互作用.
  • 无溶剂方法产生了六个月稳定的冷解粉末,保持了91.5%的药物负载.

结论:

  • 成功开发了用于制备AmB载荷脂质体的可应用方法.
  • 无溶剂方法被认为是最经济和环保的方法.
  • 这些发现支持工业制造脂质体AmB,其性能提高,毒性降低.