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用于制药和化妆品应用的新型可注射水凝胶制剂及其制剂中残留交联剂的气相色谱分析

Novel Injectable Hydrogel Formulations and Gas Chromatography Analysis of the Residual Crosslinker in Formulations Intended for Pharmaceutical and Cosmetic Applications.

作者信息

Rashid Fatimah, Carter Paul, Childs Stephen

机构信息

School of Pharmacy and Pharmaceutics, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sunderland SR1 3SD, UK.

出版信息

Gels. 2024 Apr 21;10(4):280. doi: 10.3390/gels10040280.

DOI:10.3390/gels10040280
PMID:38667699
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11049452/
Abstract

Novel hyaluronic acid (HA) crosslinked with pentaerythritol tetra-acrylate (PT) injectable hydrogels was invented. These injectable hydrogel/dermal filler formulations were synthesised using HA and the acrylate PT as a crosslinker under basic pH conditions using thermal crosslinking methods (oven heating), which provides a simple, safe, and eco-friendly method for crosslinking in 4 h under 45 °C. Fourier-transform infrared spectroscopy (FTIR) and scanning electron microscopy (SEM) analyses were conducted to represent the difference between the formulations in terms of peak formation and pore size, respectively. The crosslinking was partial as is considered to be typical for dermal injectable fillers. The rheological properties of these formulations showed that these novel dermal injectables are highly promising, and the newly developed fillers could be used with better results for dermal anti-wrinkle corrections, shaping, and volumising reasons. Furthermore, crosslinker (PT) residual analysis was carried out to state the formulations that are valid and acceptable for intradermal usage. The results from the GC method validation revealed it was a suitable method for this study. The GC analysis of all five injectable hydrogel/filler formulations demonstrated the formulations HA-PT 1, 2, 3 and 4 were formulated using (0.05-0.1)% / PT containing residual PT monomers within the safe limits that were determined to be below (0.008% /). This work has shown the development of a novel injectable hydrogel/filler formulation for pharmaceutical and cosmetic applications can be prepared in a more sustainable and simple way using pentaerythritol tetra-acrylate as a crosslinker agent, which holds great promise for the industry's future advancement.

摘要

发明了一种与季戊四醇四丙烯酸酯(PT)交联的新型透明质酸(HA)可注射水凝胶。这些可注射水凝胶/真皮填充剂配方是在碱性pH条件下,使用HA和丙烯酸酯PT作为交联剂,通过热交联方法(烘箱加热)合成的,该方法提供了一种简单、安全且环保的方法,可在45℃下4小时内完成交联。进行了傅里叶变换红外光谱(FTIR)和扫描电子显微镜(SEM)分析,分别从峰形成和孔径方面表征配方之间的差异。交联是部分交联,这被认为是真皮可注射填充剂的典型情况。这些配方的流变学性质表明,这些新型真皮可注射剂极具前景,新开发的填充剂可用于真皮抗皱矫正、塑形和填充,效果更佳。此外,还进行了交联剂(PT)残留分析,以说明适用于皮内使用的有效且可接受的配方。气相色谱法验证结果表明,该方法适用于本研究。对所有五种可注射水凝胶/填充剂配方的气相色谱分析表明,配方HA-PT 1、2、3和4使用的(0.05 - 0.1)% / PT含有残留的PT单体,其含量在确定低于(0.008% /)的安全限度内。这项工作表明,使用季戊四醇四丙烯酸酯作为交联剂,可以以更可持续和简单的方式制备用于制药和化妆品应用的新型可注射水凝胶/填充剂配方,这对该行业的未来发展具有巨大潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/97123ec33b52/gels-10-00280-g014.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/97123ec33b52/gels-10-00280-g014.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/b6159ebf4c50/gels-10-00280-g008a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/597f8409e31d/gels-10-00280-g009a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/b1a8cade6cd0/gels-10-00280-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/4307a8a037c0/gels-10-00280-g011a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/062fdde3762b/gels-10-00280-g012.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63ca/11049452/97123ec33b52/gels-10-00280-g014.jpg

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Collagen-Based Hydrogels for the Eye: A Comprehensive Review.用于眼部的基于胶原蛋白的水凝胶:综述
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Hyaluronic Acid in Biomedical Fields: New Trends from Chemistry to Biomaterial Applications.透明质酸在生物医学领域的应用:从化学到生物材料的新趋势。
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