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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:

33卷

期数:

2020年19期

页码:

62-67

栏目:

论著

出版日期:

2020-10-01

文章信息/Info

Title:

Study on Cytotoxicity and Irritation Sensitization of Metallic Aluminum Materials

文章编号:

1006-1959（2020）19-0062-06

作者:

林钟石1; 徐 良3; 钟文雨1; 林柏佑2; 徐炜区2; 袁丽欣2; 刘 尧1

深圳市药品检验研究院体外诊断试剂检测部1，无源医疗器械检测部2，医疗器械检测中心3，广东 深圳 51805

Author(s):

LIN Zhong-shi1; XU Liang3; ZHONG Wen-yu1; LIN Bai-you2; XU Wei-qu2; YUAN Li-xin2; LIU Yao1

In Vitro Diagnostic Reagent Testing Department1,Passive Medical Device Testing Department2,Medical Device Testing Center3,Shenzhen Institute of Drug Inspection Shenzhen 518057,Guangdong,China

关键词:

铝; 医疗器械; 细胞毒性; 刺激性; 皮肤致敏性

Keywords:

Aluminum; Medical device; Cytotoxicity; Irritation; Skin sensitization

分类号:

TG113.2

DOI:

10.3969/j.issn.1006-1959.2020.19.019

文献标志码:

A

摘要:

目的 评价金属铝的细胞毒性、刺激性和皮肤致敏性，为金属铝材料在医疗器械领域的制造和应用提供安全依据。方法 本研究模拟金属铝材料在医疗器械中的常规应用，采用抛光处理后的金属铝片评估该金属铝片的细胞毒性和刺激致敏性。细胞毒性试验选用浓度1×105个/ml生长良好的L929小鼠成纤维细胞悬液使用MTT法检测，并计算细胞存活率；刺激试验将9只新西兰兔通过完全随机分成样品极性浸提液和空白对照组、样品非极性浸提液和空白对照组和阳性对照组，每组3只。将受试液滴到纱布上，贴敷于脊柱两侧固定4 h后去除，观察水清洗后1、24、48和72 h皮肤表面，计算原发性刺激并后确定反应类型；皮肤致敏试验将50只豚鼠通过完全随机分成样品极性浸提液组、空白对照组、样品非极性浸提液组、空白对照组和阳性对照组，每组10只。经动物肩膀内侧注射受试液皮内诱导，观察贴敷结束后24 h和48 h受试部位情况及Magnusson和Kligman评级。结果 细胞毒性试验中L929细胞与样品浸提液接触24h后与空白对照中的细胞显微镜下观察无形态上的差异且噻唑兰检测存活率大于70%；刺激试验中，贴敷结束后1、24、48和72h样品浸提液的皮肤反应均为无红斑无水肿；皮肤致敏试验中，贴敷结束后24和48 h样品浸提液的皮肤反应均为无红斑无水肿。结论 样品浸提液无潜在的细胞毒性、刺激性及皮肤致敏性，金属铝的生物安全性符合现有标准对于与完整皮肤接触和部分与黏膜接触（≤24 h）的表面器械的生物安全性要求，但其在低pH环境下的使用，还需要进一步的研究。

Abstract:

Objective To evaluate the cytotoxicity, irritation and skin sensitization of metallic aluminum, and provide a safety basis for the manufacture and application of metallic aluminum materials in the field of medical devices.Methods This study simulates the conventional application of metal aluminum materials in medical devices, and use polished metal aluminum sheets to evaluate the cytotoxicity and irritation sensitization of the metal aluminum sheets. In the cytotoxicity test, a well-growing L929 mouse fibroblast suspension with a concentration of 1×105 cells/ml was used to detect the MTT method, and the cell survival rate was calculated; in the stimulation test, 9 New Zealand rabbits were completely randomly divided into sample polar extracts and blank control group, sample non-polar extract, blank control group and positive control group, 3 in each group. Drop the test solution onto gauze, stick it on both sides of the spine and fix it for 4 h before removing. Observing the skin surface at 1, 24, 48 and 72 h after washing with water, calculate the primary irritation and determine the type of reaction; skin sensitization in the experiment, 50 guinea pigs were completely randomly divided into a sample polar extract group, a blank control group, a sample non-polar extract group, a blank control group and a positive control group, with 10 in each group. Intradermal induction of the test solution was injected into the inside of the animal’s shoulder, and the condition of the test site and the Magnusson and Kligman ratings were observed 24 h and 48 h after the application.Results In the cytotoxicity test, the L929 cells were in contact with the sample extract for 24 h, and there was no morphological difference between the cells in the blank control, and the survival rate of thiazolyl was greater than 70%; In the irritation test, the skin reaction of the sample extract at 1, 24, 48 and 72 h after the application was no erythema and no edema; in the skin sensitization test, the skin reaction of the sample extract at 24 and 48 h after the application all were without erythema and edema.Conclusion The sample extract had no potential cytotoxicity, irritation and skin sensitization. The biological safety of metallic aluminum meet the existing standards. The biological safety of surface devices that were in contact with intact skin and partly in contact with mucosa (≤24 h) However, its use in a low pH environment requires further research.

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更新日期/Last Update: 1900-01-01