在真空泡干燥过程中影响泡性能的配方因素
Daniel Tristan Osanlóo1, Denny Mahlin2, Simon Bjerregaard3
1RISE Research Institutes of Sweden, Box 5604, Stockholm SE-114 86, Sweden; University of Lund, Department of Food Technology, Engineering, and Nutrition, Box 117, Lund SE-221 00, Sweden.
International journal of pharmaceutics
|January 13, 2024
概括
蛋白质的真空泡干燥受配方的影响. 蛋白质药物可以有效地稳定使用分糖类如糖糖或三糖作为矩阵形成剂,保持干燥后的活性.
科学领域:
- 生物技术是生物技术.
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 在干燥过程中蛋白质的稳定性对于药物配方至关重要.
- 真空泡干燥是保护蛋白质结构和功能的有希望的技术.
- 了解配方影响是优化这一过程的关键.
研究的目的:
- 为了研究配方参数对蛋白质真空泡干燥的影响.
- 评估矩阵形成剂和表面活性剂对泡结构和蛋白质稳定性的影响.
- 在干燥过程中和干燥后评估物理性能和蛋白质药物稳定性.
主要方法:
- 利用复合人类胆汁盐刺激脂酶作为一种模型蛋白质药物.
- 采用糖和三作为矩阵形成剂,评估物理性质 (剩余水,玻璃过渡温度,晶体状态).
- 研究的表面活性剂头组对泡性和表面覆盖的影响,保持基链长度不变.
主要成果:
- 使用模型蛋白质,使用高泡超量 (高达2600%) 获得干燥,固体泡.
- 估计泡壁厚度在20-50微米之间.
- 观察到砂糖和三糖之间的明显差异作为矩阵构造物.
- 经过干燥和再水后,即使表面覆盖,也没有证实脂酶活性丧失.
结论:
- 配方参数显著影响蛋白质真空泡干燥结果.
- 脱糖酸是有效的矩阵形成剂,可以在泡干燥过程中稳定蛋白质药物.
- 开发的真空泡干燥方法保留了蛋白质活性,显示了制药应用的潜力.
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