新型脂质创面敷料透皮液和溶出液中三溴苯酚及铋元素的分析测定及其细胞毒性研究

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Abstract This article establishes the safety evaluation of a novel lipid wound dressing (ZDG20180819) through in vitro experiments (dissolution, transdermal) and cytotoxicity experiments. To establish an analytical method based on inductively coupled plasma-mass spectrometry (ICP-MS) and gas chromatography-mass spectrometry (GC-MS) to measure lipid wound dressing. Residues (tribromophenol and bismuth) in dissolution and transdermal fluids. At the same time, the material toxicity of the lipid wound dressing was judged by the colorimetric assay of tetrazolium salt (MTT). The dissolution per unit area of tribromophenol in the dissolution fluids was (6.91±1.34) μg/cm², (6.71±0.81) μg/cm², (6.41±1.40) μg/cm² and the dissolution per unit area of bismuth was (0.008 6±0.000 5) ng/cm², (0.009 7±0.001 8) ng/cm², (0.055 6±0.006 8) ng/cm² in 2, 4, and 7 days. The transdermal per unit area of tribromophenol in transdermal fluids was (0.16±0.01) μg/cm², (1.11±0.01) μg/cm², and the transdermal per unit area of bismuth was (0.003 6±0.000 1) ng/cm², (0.011 7±0.001 5) ng/cm² in 1 d and 2 d. The cytotoxicity experiments results prove that the lipid wound dressing used in this experiment is less toxic to Hacat and HSF with a level of 0 or 1. The residue of the lipid wound dressing used in this experiment is low in the dissolution and transdermal fluids and the cytotoxicity level of the lipid wound dressing is low, which is enough to explain the safety of the lipid wound dressing.

Key words： lipid wound dressing inductively coupled plasma-mass spectrometry (ICP-MS) gas chromatography-mass spectrometry (GC-MS) cytotoxicity experiments

Published: 08 January 2021

CLC number:

R944.6

Fund:This work was financially supported by the Key Science and Technology Innovation Team of Zhejiang Province (2013TD15).

About author:: Rongrong Li received her B.E. degree in Pharmaceutical Engineering from the Huangshan University in 2018. She is currently pursuing her M.S. at College of Pharmaceutical Science, the Zhejiang University of technology (ZJUT) under the supervision of Prof. Fengsen Ma. Her research has focused on the evaluation of materials and delivery of vaccines. Haibo Chen, master graduate student, graduated from the college of the Zhejiang University of Technology (ZJUT). He works at Zhejiang Institute of Medical Device testing. He is engaged in the biological safety eva-luation and research of medical devices and biomate-rials. He has accumulated rich experience in animal experiments and cell experiments. He has participated in a number of biomaterials research projects and published relevant research papers.Fengsen Ma obtained his M.E. degree from Zhejiang University. He is currently a professor and PHD supervisor of Zhejiang University of Technology (ZJUT). As a senior expert in the pharmaceutical research of Zhejiang Province, he is the principal person in charge of the two professional committees including biopharmaceuticals and medical devices. His laboratory has been engaged in the research and development of novel transdermal pre-parations, biopharmaceuticals and biological materials for many years. The basis of related research work, team, common key technologies and the application of products have been accumulated, especially for the system of microneedles technology. The team already has a lot of national invention patents and papers.

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	LI Rongrong
	WANG Yuan
	LIU Yong
	LIU Zhe
	ZHENG Yan
	HU Xiuyuan
	CHEN Haibo
	MA Fengsen

Cite this article:

LI Rongrong,WANG Yuan,LIU Yong, et al. Determination of Tribromophenol and Bismuth Elements in the Transdermal and Dissolution Fluids of a Novel Lipid Wound Dressing and Study of Its Cytotoxicity[J]. Materials Reports, 2020, 34(Z2): 490-495.

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http://www.mater-rep.com/EN/ OR http://www.mater-rep.com/EN/Y2020/V34/IZ2/490

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