基于QbD的配方开发,将白醇纳米晶体纳入可溶性半孔材料:药理学证明概念研究的药理学证明
Ahmad Ainurofiq1, Bingah Ginanjar Rahayu2, Faradisania Adnan Murtadla2
1Pharmaceutical Technology and Drug Delivery, Department of Pharmacy, Universitas Sebelas Maret, Ir. Sutami 36A, Surakarta, 57126 Indonesia.
International journal of pharmaceutics
|July 12, 2024
概括
这项研究在中孔载体中开发了新型的复星 (RSV) 纳米晶体,显著提高了生物可用性. 这种配方克服了RSV.
科学领域:
- 药理学 药理学是指药理学的学科.
- 材料科学 材料科学 材料科学
- 纳米技术 纳米技术
背景情况:
- 复星 (RSV) 具有强大的抗氧化特性,但由于溶解度低和运输挑战,其生物可用性较差.
- 现有的纳米晶技术面临着稳定性和可扩展性问题,特别是当它们被制成纳米悬浮时.
研究的目的:
- 通过在可溶性半孔载体中制备纳米晶体来增强复星的生物可用性.
- 为了实现优越的固态稳定性和可行性,复星纳米晶配方.
- 为了优化纳米晶体配方使用设计质量方法和盒子-Behnken设计.
主要方法:
- 开发了通过溶剂蒸发将Resveratrol纳米晶体纳入中孔载体的方法.
- 使用Box-Behnken设计优化配方参数,包括颗粒大小,药物负载,泽塔潜力和超和.
- 使用光谱学,热分析,电子显微镜和结晶性评估进行全面的表征.
主要成果:
- 优化的配方实现了133.3 ± 1.2 nm的粒子大小和-24.6 mV的泽塔电位,具有68%的可取性.
- 鉴定证实,复星和中性载体之间没有化学相互作用.
- 在纳米晶体配方中,与原生白醇相比,白醇的结晶性保持不变.
结论:
- 纳米晶体的resveratrol融入中孔载体提供了更好的固态稳定性和可行性.
- 这种新型配方显著提高了复星的生物可用性,与RSV悬浮相比几乎翻了一番.
- 通过设计的质量方法和Box-Behnken设计在优化纳米晶体配方方面是有效的.
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