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

Abstract

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

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.

Figures/Tables 4

References 28

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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

Cytotoxicity and mechanical properties of the prosthetic liner

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