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
Ningyun Sun, Jing Zhang, Mingtao Guo, Yibin Mao, Wei Wu, Yi Lu
{"title":"通过高光谱拉曼成像分析评估 \"药片内 \"的化学分布均匀性","authors":"Ningyun Sun, Jing Zhang, Mingtao Guo, Yibin Mao, Wei Wu, Yi Lu","doi":"10.1007/s11095-024-03778-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to develop a new index, Distribution Uniformity Index (DUI), to assess the \"intra-tablet\" homogeneity.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 CaSO<sub>4</sub>·2H<sub>2</sub>O 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.</p><p><strong>Conclusions: </strong>DUI represents a novel index to evaluate the \"intra-tablet\" homogeneity and is beneficial for formulation research and development.</p>","PeriodicalId":20027,"journal":{"name":"Pharmaceutical Research","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Chemical Distribution Uniformity Assessment of \\\"Intra-Tablet\\\" by Hyperspectral Raman Imaging Analysis.\",\"authors\":\"Ningyun Sun, Jing Zhang, Mingtao Guo, Yibin Mao, Wei Wu, Yi Lu\",\"doi\":\"10.1007/s11095-024-03778-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>This study aimed to develop a new index, Distribution Uniformity Index (DUI), to assess the \\\"intra-tablet\\\" homogeneity.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 CaSO<sub>4</sub>·2H<sub>2</sub>O 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.</p><p><strong>Conclusions: </strong>DUI represents a novel index to evaluate the \\\"intra-tablet\\\" homogeneity and is beneficial for formulation research and development.</p>\",\"PeriodicalId\":20027,\"journal\":{\"name\":\"Pharmaceutical Research\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-11-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceutical Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11095-024-03778-z\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11095-024-03778-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Pharmaceutical Research
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.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信