开发和临床前评估含有尼克尔戈林,皮拉塞坦和棘提取物治疗神经感官听力损失的固定剂量囊
Lucia Maria Rus1, Andrei Uncu2, Sergiu Parii2
1Department of Pharmaceutical Analysis, Faculty of Pharmacy, "Iuliu Hațieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.
Pharmaceutics
|August 28, 2025
概括
一种新的固定剂量囊, 结合尼瑟戈林, 皮拉塞坦, 和棘提取物显示治疗神经听力损失的希望. 在临床前评估中,该配方表现出良好的稳定性,安全性和抗氧化特性.
科学领域:
- 药理学
- 药物开发
- 耳鼻喉科
背景情况:
- 听力障碍是耳鼻喉学领域日益关注的问题.
- 固定剂量组合在各种医学领域具有治疗优势.
研究的目的:
- 开发和评估一种用于神经感官听力损失的新囊配方.
- 这种囊结合了尼瑟戈林 (NIC),皮拉 (PIR) 和棘提取物 (HE).
主要方法:
- 预制药研究 (DSC,FTIR,PXRD) 评估了药物辅助剂的兼容性.
- 对配方进行技术性质,溶解性和稳定性评估.
- 使用光谱测量和HPLC-UV对活性化合物和黄的量化.
主要成果:
- F1配方 (4. 5毫克NIC,200毫克PIR,50毫克HE) 呈现出最佳的特性和优异的溶解.
- 通过DPPH,TEAC和铁化试验证实了抗氧化活性.
- 急性毒性和耳部毒性研究表明安全度很高,没有听觉不良影响.
结论:
- 开发的固定剂量组合囊显示出良好的稳定性,安全性和对听力损失的治疗潜力.
- 这种工作流可以作为未来固定剂量组合开发的模型.
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