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材料导报  2020, Vol. 34 Issue (Z2): 490-495    
  高分子与聚合物基复合材料 |
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
李蓉蓉1, 王缘1, 刘勇1, 刘哲1, 郑燕1, 胡修元2, 陈海波3, 马凤森1
1 浙江工业大学药学院生物制剂与材料实验室,杭州 310014
2 振德医疗用品股份有限公司,绍兴 312035
3 浙江省医疗器械检验研究院,杭州 310018
Determination of Tribromophenol and Bismuth Elements in the Transdermal and Dissolution Fluids of a Novel Lipid Wound Dressing and Study of Its Cytotoxicity
LI Rongrong1, WANG Yuan1, LIU Yong1, LIU Zhe1, ZHENG Yan1, HU Xiuyuan2, CHEN Haibo3, MA Fengsen1
1 Laboratory of Biologicals and Biomaterials, College of Pharmacy, Zhejiang University of Technology, Hangzhou 310014, China
2 Zhende Medical Supplies Co Ltd, Shaoxing 312035, China
3 Zhejiang Institute of Medical Device Testing, Hangzhou 310018, China
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摘要 本文通过体外实验(溶出、透皮)、细胞毒性实验建立脂质创面敷料的安全性评价。 建立基于电感耦合等离子体质谱(ICP-MS)和气相色谱质谱联用(GC-MS)测量溶出液、透皮液中新型脂质创面敷料残留物(三溴苯酚和铋)的分析方法。同时,使用四唑盐(MTT)比色法判断新型脂质创面敷料的材料毒性。结果表明,溶出液在2天、4天、7天内三溴苯酚的单位面积溶出量分别为(6.91±1.34) μg/cm2、(6.71±0.81) μg/cm2、(6.41±1.40) μg/cm2,铋的单位面积溶出量分别为(0.008 6±0.000 5) ng/cm2、(0.009 7±0.001 8) ng/cm2、(0.055 6±0.006 8) ng/cm2。透皮液在1天、2天内三溴苯酚的单位面积透过量分别为(0.16±0.01) μg/cm2、(1.11±0.01) μg/cm2,铋的单位面积透过量分别为(0.003 6±0.000 1) ng/cm2、(0.011 7±0.001 5) ng/cm2。细胞毒性实验结果证明本实验所用的脂质创面敷料对Hacat、HSF两种细胞毒性较小,等级为0或1。本实验所用新型脂质创面敷料的残留物在溶出液和透皮液中含量较低,细胞毒性等级较低,足以说明脂质创面敷料的安全性。
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李蓉蓉
王缘
刘勇
刘哲
郑燕
胡修元
陈海波
马凤森
关键词:  脂质创面敷料  电感耦合等离子体质谱(ICP-MS)  气相色谱质谱联用(GC-MS)  细胞毒性实验    
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
               出版日期:  2020-11-25      发布日期:  2021-01-08
ZTFLH:  R944.6  
基金资助: 基金项目:浙江省重点科技创新团队计划资助(2013TD15)
通讯作者:  merrigen@126.com;615354985@qq.com   
作者简介:  李蓉蓉,2018年毕业于黄山学院制药工程专业,获得工学学士学位。现为浙江工业大学药学院硕士研究生,在马凤森教授的指导下进行研究。目前主要研究领域为材料的评价和疫苗的递送。陈海波,硕士,毕业于浙江工业大学药学院,任职于浙江省医疗器械检验研究院,从事医疗器械和生物材料的生物学安全性评价研究工作,积累了丰富的动物实验和细胞实验经验,参与多项生物材料的研究课题,并发表相关论文。马凤森,浙江工业大学教授,博士研究生导师。作为浙江省药学界的资深专家,担任浙江省药学会生物制药和医疗器械两个专业委员会的主要负责人。带领的实验室多年来专业从事经皮新型药物制剂、生物药物和生物材料等的研究开发工作,积累了相关研究工作与团队、共性关键技术、系列产品应用等方面的基础,尤其是近些年来对微针阵列技术的系统深入研究。已申请/获得多项国家发明专利,发表了多篇论文。
引用本文:    
李蓉蓉, 王缘, 刘勇, 刘哲, 郑燕, 胡修元, 陈海波, 马凤森. 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[J]. 材料导报, 2020, 34(Z2): 490-495.
LI Rongrong, WANG Yuan, LIU Yong, LIU Zhe, ZHENG Yan, HU Xiuyuan, CHEN Haibo, MA Fengsen. Determination of Tribromophenol and Bismuth Elements in the Transdermal and Dissolution Fluids of a Novel Lipid Wound Dressing and Study of Its Cytotoxicity. Materials Reports, 2020, 34(Z2): 490-495.
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http://www.mater-rep.com/CN/  或          http://www.mater-rep.com/CN/Y2020/V34/IZ2/490
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