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

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。

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.