假肢接受腔内衬套的细胞毒性及力学性能检测

doi:10.3969/j.issn.1006-9771.2022.04.016

《中国康复理论与实践》 ›› 2022, Vol. 28 ›› Issue (4): 479-483.doi: 10.3969/j.issn.1006-9771.2022.04.016

假肢接受腔内衬套的细胞毒性及力学性能检测

栾会芹^1,^2,³,毕经芳⁴,吴赛男^1,^2,³,任韦燕^1,³,刘红梅⁵,张莹莹^1,³,李增勇^1,³()

1.国家康复辅具研究中心,北京市 100176
2.国家康复辅具研究中心康复辅具质量监督检验中心,北京市 100176
3.民政部康复辅具分析评定重点实验室,北京市 100176
4.山东省泰安市中心医院,山东泰安市 271000
5.国家康复辅具研究中心附属康复医院,北京市100176

收稿日期:2021-07-06 修回日期:2022-02-10 出版日期:2022-04-25 发布日期:2022-05-05
通讯作者: 李增勇 E-mail:lizengyong@nrcrta.cn
作者简介:栾会芹(1974-),女,汉族,山东济南市人,博士,高级工程师,主要研究方向：运动康复及康复辅具产品生物学评价。
基金资助:
国家自然科学基金项目(11902089);国家自然科学基金项目(11902090);中央级公益性科研院所基本科研业务费专项资金项目(118009001000160001)

Cytotoxicity and mechanical properties of the prosthetic liner

LUAN Huiqin^1,^2,³,BI Jingfang⁴,WU Sainan^1,^2,³,REN Weiyan^1,³,LIU Hongmei⁵,ZHANG Yingying^1,³,LI Zengyong^1,³()

1. National Research Center for Rehabilitation Technical Aids, Beijing 100176, China
2. National Quality Supervision and Inspection Center for Rehabilitation Technical Aids, Beijing 100176, China
3. Key Laboratory of Rehabilitation Technical Aids Analysis and Identification of the Ministry of Civil Affairs, Beijing 100176, China
4. Tai'an City Central Hospital, Tai'an, Shandong 271000, China
5. Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Beijing 100176, China

Received:2021-07-06 Revised:2022-02-10 Published:2022-04-25 Online:2022-05-05
Contact: LI Zengyong E-mail:lizengyong@nrcrta.cn
Supported by:
National Natural Science Foundation of China(11902089);National Natural Science Foundation of China(11902090);Fundamental Research Funds for Central Public Welfare Research Institutes(118009001000160001)

摘要/Abstract

摘要：

目的调查研究国内市售假肢接受腔内衬套的细胞毒性及力学性能现状。方法收集国产厚度6 mm泡沫内衬(A)、国产厚度5 mm EVA泡沫内衬(B)、德国产厚度5 mm EVA泡沫内衬(C)、德国产厚度12 mm PE泡沫内衬套(D)、冰岛产厚度3 mm硅胶内衬套(E)、德国产厚度4 mm凝胶内衬套(F)。应用显微镜观察与噻唑蓝比色法,进行不同内衬套细胞毒性检测。采用高锰酸钾消耗测定有机小分子物质含量。采用材料力学试验机对内衬套材料进行拉伸强度、扯断伸长率(%)、100%定伸强度的检测。采用邵氏硬度计进行硬度测试。结果内衬套A、B、C和D的细胞毒性反应均为2级,内衬套E和F的细胞毒性反应均为0级。内衬套A、B、C高锰酸钾消耗量均超过150 mg/kg。除内衬套C外,其余5种产品硬度均≤ 70 HA。除内衬套D外,其余5种产品均拉伸强度> 1 MPa,断裂伸长率> 120.0%,100%定伸强度> 0.9 MPa。结论因材料和生产工艺等原因6种样品的细胞毒性和力学性能有较大差异。

关键词: 假肢接受腔内衬套, 细胞毒性, 力学性能

Abstract:

Objective To investigate the current status of cytotoxicity and mechanical properties of the prosthetic liner on the market in China.Methods Six kinds of liner were collected, namely domestic 6 mm thick foam liner (A), domestic 5 mm thick EVA foam liner (B), German 5 mm thick EVA foam liner (C), Germany 12 mm thick PE foam liner (D), Iceland 3 mm thick silicone liner (E) and Germany 4 mm thick gel liner (F). Microscopic observation and thiazole blue colorimetry were used to detect the cytotoxicity. The content of small organic molecules was determined by the consumption of potassium permanganate. The tensile strength, elongation at break (%), and 100% tensile strength of the prosthetic liner were tested by material mechanics testing machine. The hardness was tested using the Shore hardness tester oo type.Results The cytotoxicity was grade 2 for prosthetic liners A, B, C and D, and was grade 0 for E and F. The redox substance content of prosthetic liners A、B、C exceeded 150 mg/kg. Except the prosthetic liner C, the hardness of the other products were all ≤ 70 HA. Except prosthetic liner D, the tensile strengths were > 1 MPa, breaking elongations were > 120.0%, 100% tensile strengths were > 0.9 MPa for other products.Conclusion Due to materials and production processes, the cytotoxicity and mechanical properties of the six samples are quite different.

Key words: prosthetic liner, cytotoxicity, mechanical properties

栾会芹,毕经芳,吴赛男,任韦燕,刘红梅,张莹莹,李增勇. 假肢接受腔内衬套的细胞毒性及力学性能检测[J]. 《中国康复理论与实践》, 2022, 28(4): 479-483.

LUAN Huiqin,BI Jingfang,WU Sainan,REN Weiyan,LIU Hongmei,ZHANG Yingying,LI Zengyong. Cytotoxicity and mechanical properties of the prosthetic liner[J]. 《Chinese Journal of Rehabilitation Theory and Practice》, 2022, 28(4): 479-483.

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级别	RGR/%	反应程度
0	≥ 100	无
1	80~99	极轻微
2	50~79	轻度
3	30~49	中度
4	0~29	重度

样品	OD	RGR/%	毒性分级
A	0.4855±0.0138	70	2
B	0.4085±0.0208	59	2
C	0.3547±0.0251	52	2
D	0.3709±0.0341	54	2
E	0.6892±0.0086	101	0
F	0.6942±0.0094	100	0
空白对照	0.6863±0.0034	-	0
阴性对照	0.6720±0.0105	97	1
阳性对照	0.1997±0.0016	29	4

样品	高锰酸钾消耗量
A	229.10±11.52
B	158.92±7.98
C	160.73±6.77
D	57.91±10.32
E	74.95±8.72
F	75.11±8.98

样品	硬度(shore 00)/HA	拉伸强度/MPa	断裂伸长率/%	100%定伸强度/MPa
A	62.5±0.31	1.55±0.03	220.11±0.17	1.10±0.03
B	61.6±0.27	1.07±0.01	117.64±0.05	1.09±0.04
C	76.1±0.40	2.82±0.04	215.81±0.38	1.61±0.03
D	61.5±0.40	0.64±0.02	138.73±0.88	0.56±0.01
E	63.84±0.73	1.45±0.05	103.58±0.11	1.11±0.13
F	56.98±0.69	1.54±0.05	145.86±0.26	1.09±0.06

假肢接受腔内衬套的细胞毒性及力学性能检测

Cytotoxicity and mechanical properties of the prosthetic liner

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