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确保HME的质量控制,使用便携式拉曼光谱仪对皮丝进行定量分析

Antoine Dowek¹, Aruzhan Seidakhanova¹, Quentin Bourcy²

¹Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 94800 Villejuif, France; Université Paris-Saclay, Lipides : systèmes analytiques et biologiques, 91400 Orsay, France.

Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

|October 8, 2025

概括

一种新的拉曼光谱法在3D打印的药物纤维中准确量化皮质 (HCT). 这种质量控制工具确保了个性化药物的安全性和有效性.

科学领域:

制药科学制药科学
分析化学分析化学
材料科学材料科学材料科学

背景情况:

3D打印使个性化药物和复杂的药物配方成为可能.
质量控制对于3D打印药物的安全性和有效性至关重要.
拉曼光谱为分析制药材料提供了一个强大的工具.

研究的目的:

开发一种定量分析方法,用于检测药用纤维的度.
适应已验证的HCT量化方法,用于在3D打印丝中进行直接分析.
评估便携式拉曼光谱仪用于导线质量控制的准确性和适用性.

主要方法:

根据ICH指南,建立并验证了溶液中HCT的定量方法.
调整了在光线中直接量化HCT的方法 (20%的HCT和辅助剂).
优化了光谱区域选择和预处理技术 (平滑,基线校正,衍生品,EMCSC).

主要成果:

成功地适应了拉曼光谱法,用于直接在发光线内对HCT进行量化.
在三批发发光线中实现了对目标HCT度的高精度.
在发光线中测量HCT的平均绝对误差为2.96%.

结论:

便携式拉曼探针对于实时控制制药纤维的质量非常有价值.
这种方法可以确保用于3D打印个性化药物的光纤质量.
开发的技术支持个性化固体口服剂型的安全有效生产.

关键词:

3D打印的药物可以使用3D打印.在FDM的FDM.皮糖是一种酸盐.定性分析是一种定性分析.定量分析是一种量化分析.拉曼光谱法拉曼光谱法拉曼光谱法

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