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同形态系统中的"老化":在没有再结晶的储存过程中,溶解的减少和溶解的显著增加.

Luyan Shen1, Xianzhi Liu1, Wencheng Wu1

  • 1Chemical Biology Research Center, School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou 325035, Zhejiang, China; Wenzhou Institute, University of Chinese Academy of Science, Wenzhou 325024, Zhejiang, China.

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概括

同形态系统增强了药物的溶解性,但它们的溶解率在储存期间可能会发生变化. 这项研究表明,即使保持无形形式,溶解率也可能下降或增加,这突显了存储稳定性的担忧.

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衰老的衰老 衰老的衰老同形态系统是同形态系统.内在溶解率 (IDR) 是指内在的溶解率.物理稳定性 物理稳定性水溶性较差的药物 在水溶性较差的药物

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科学领域:

  • 制药科学 制药科学
  • 材料科学 材料科学 材料科学

背景情况:

  • 同形态系统是改善水溶性较差药物的可溶性的一个关键策略.
  • 之前的研究主要集中在储存后共同形态系统的初始溶解速率和物理稳定性.

研究的目的:

  • 研究储存对同形态系统溶解速率的影响,而不仅仅是物理形式稳定性.
  • 了解影响储存期间溶解速率变化的因素.

主要方法:

  • 准备与氨酸,氨酸和氨酸配合的印梅他辛共形系统.
  • 系统在干燥和高湿度 (60%RH) 条件下存储40天和80天.
  • 评估物理稳定性 (再结晶) 和内在溶解率 (IDR).

主要成果:

  • 在储存后的同形态系统中没有观察到再结晶.
  • 在储存后观察到内在溶解率 (IDR) 显著下降和意外增加.
  • 分子混合和储存期间的水分吸收被确定为影响IDR变化的潜在因素.

结论:

  • 保持同形态系统的无形形式并不能保证它们增强的溶解速率的保存.
  • 溶解速率的变化,无论是减少还是增加,都必须在同形态系统的储存过程中仔细评估.
  • 对同形态系统的衰老机制进行进一步研究是有必要的.