喷雾干燥血清用于吸入抗病毒疗法.
Saveria Germani1,2, Miriam Polichetti1, Valentina Garrapa3
1Food and Drug Department, University of Parma, Parco Area delle Scienze 27/a, 43124 Parma, Italy.
Pharmaceutics
|December 31, 2025
概括
从免疫小鼠血清开发可吸入粉末,为抗击SARS-CoV-2提供了一个有前途的策略. 这些多克隆抗体配方显示出良好的气溶性能和蛋白质稳定性,克服了单克隆抗体的局限性.
科学领域:
- 制药科学 制药科学
- 免疫学 免疫学 免疫学
- 呼吸系统医学 呼吸系统医学
背景情况:
- 针对呼吸道病毒的单克隆抗体面临病毒突变带来的挑战.
- 血清衍生的多克隆抗体提供了对病毒逃逸的更广泛的保护.
- 开发可吸入的抗体疗法对于呼吸道感染至关重要.
研究的目的:
- 开发可吸入的粉末,含有针对SARS-CoV-2免疫的老鼠血清.
- 评估配方的气溶性能和蛋白质稳定性.
- 为了确定稳定,可呼吸的抗体粉末的最佳辅助剂.
主要方法:
- 选糖和氨基酸辅助剂以稳定蛋白质.
- 配方开发使用清洁和白素贫血清与选定的辅助剂 (HPβCD,L-氨酸,三糖,甘氨酸).
- 对喷雾干燥粉末的评价,包括颗粒大小,气溶性能 (MMAD,FPF),湿透性和免疫球蛋白活性.
主要成果:
- 糖和氨基酸的组合改善了蛋白质大小的保留和减少水分.
- 所有喷雾干燥配方都产生了高微粒分数 (70-80%) 的可呼吸颗粒 (MMAD ≤5μm).
- 氨酸提高了气溶的分散性,降低了湿度和聚合性;白蛋白改善了免疫球蛋白的活性.
结论:
- 可吸入的多克隆抗体粉末可用于SARS-CoV-2的预防.
- 与HPβCD结合的L-氨酸提供了空气动力学特性和蛋白质稳定性的最佳平衡.
- 专增强了免疫球蛋白的活性,而缓冲区选择的影响最小.
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