通过高光谱拉曼成像分析评估 "药片内 "的化学分布均匀性

IF 3.5 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY Pharmaceutical Research Pub Date : 2024-11-06 DOI:10.1007/s11095-024-03778-z

Ningyun Sun, Jing Zhang, Mingtao Guo, Yibin Mao, Wei Wu, Yi Lu

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引用次数: 0

摘要

目的：本研究旨在开发一种新的指数--分布均匀性指数（DUI），以评估 "片剂内部 "的均匀性。方法：采用高分辨率高光谱拉曼成像技术扫描片剂，以获得各成分的分布情况。采用启发式算法生成拉曼热图，其 RGB 颜色与各成分的浓度定量相关。DUI 的定义是样品图像均匀性曲线下的面积与随机图像均匀性曲线下的面积之比。通过构建具有受控均匀性和随机区域的模型图像，验证了 DUI 的准确性和适用性。研究了 "片内 "均匀性对螺内酯片崩解和溶出的影响：通过对高光谱拉曼图像中的宏观像素进行启发式视觉分析，直接获得了 DUI 值。结果表明，DUI 值与模型图像的均匀性之间具有良好的线性关系和可重复性。CaSO4-2H2O 的大小会影响螺内酯片剂的 "片内 "均匀性，这一点可通过 DUI 值检测出来。片内 "均匀性越好，螺内酯片的崩解和溶解度就越高：结论：DUI 是评价 "片内 "均一性的新指标，有利于制剂的研究和开发。

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Chemical Distribution Uniformity Assessment of "Intra-Tablet" by Hyperspectral Raman Imaging Analysis.

Purpose: This study aimed to develop a new index, Distribution Uniformity Index (DUI), to assess the "intra-tablet" homogeneity.

Methods: High-resolution hyperspectral Raman imaging was adopted to scan a tablet to get the components' distribution. The heuristic algorithm was applied to generate a Raman heatmap with RGB colors quantitatively correlated with the concentrations of each component. DUI is defined as the ratio of the area under the uniformity curve of the sample image to that of the randomized image. The accuracy and applicability of DUI were verified by constructing model images with controlled uniformity and random regions. The effects of "intra-tablet" homogeneity on the disintegration and dissolution of spironolactone tablets were investigated.

Results: DUI value was directly obtained from heuristic visual analysis of macro-pixel from hyperspectral Raman images. A good linear relationship and good repeatability were confirmed between DUI and the uniformity of model images. The size of CaSO₄·2H₂O affected the "intra-tablet" homogeneity of spironolactone tablets, which was detected by the DUI value. The better "intra-tablet" homogeneity led to a higher disintegration and dissolution of spironolactone tablets.

Conclusions: DUI represents a novel index to evaluate the "intra-tablet" homogeneity and is beneficial for formulation research and development.

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来源期刊

Pharmaceutical Research 医学-化学综合

CiteScore

6.60

自引率

5.40%

发文量

276

审稿时长

3.4 months

期刊介绍： Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.