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  

Determination of Tribromophenol and Bismuth Elements in the Transdermal andDissolution Fluids of a Novel Lipid Wound Dressing and Study of Its Cytotoxicity

作　　者：李蓉蓉 王缘 刘勇 刘哲 郑燕 胡修元 陈海波 马凤森[1] LI Rongrong;WANG Yuan;LIU Yong;LIU Zhe;ZHENG Yan;HU Xiuyuan;CHEN Haibo;MA Fengsen(Laboratory of Biologicals and Biomaterials,College of Pharmacy,Zhejiang University of Technology,Hangzhou 310014,China;Zhende Medical Supplies Co Ltd,Shaoxing 312035,China;Zhejiang Institute of Medical Device Testing,Hangzhou 310018,China)

机构地区：[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

出　　处：《材料导报》2020年第S02期490-495,共6页Materials Reports

基　　金：浙江省重点科技创新团队计划资助(2013TD15)。

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/cm^2、(6.71±0.81)μg/cm^2、(6.41±1.40)μg/cm^2,铋的单位面积溶出量分别为(0.0086±0.0005)ng/cm^2、(0.0097±0.0018)ng/cm^2、(0.0556±0.0068)ng/cm^2。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/cm^2、(1.11±0.01)μg/cm^2,铋的单位面积透过量分别为(0.0036±0.0001)ng/cm^2、(0.0117±0.0015)ng/cm^2。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。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/cm^2,(6.71±0.81)μg/cm^2,(6.41±1.40)μg/cm^2 and the dissolution per unit area of bismuth was(0.0086±0.0005)ng/cm^2,(0.0097±0.0018)ng/cm^2,(0.0556±0.0068)ng/cm^2 in 2,4,and 7 days.The transdermal per unit area of tribromophenol in transdermal fluids was(0.16±0.01)μg/cm^2,(1.11±0.01)μg/cm^2,and the transdermal per unit area of bismuth was(0.0036±0.0001)ng/cm^2,(0.0117±0.0015)ng/cm^2 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.

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 

分 类 号：R944.6[医药卫生—药剂学]