Biocompatibility of a new medical nickel-free stainless steel

doi:10.3969/j.issn.2095-4344.2015.47.011

Abstract

Abstract:

BACKGROUND: BIOSSN4 nickel-free stainless steel is an austenitic medical stainless steel material, which has passed the standard hemolysis test, cytotoxicity assays and sensitization test of the National Institute for the Control of Pharmaceutical and Biological Products.

OBJECTIVE: To evaluate the in vitro cytotoxicity and corrosion resistance of a new medical BIOSSN4 nickel-free stainless steel.

METHODS:The L929 mouse fibroblasts suspension was seeded in 96-well plates at a concentration of 1×10⁸ /L, and were divided into five groups. BIOSSN4 nickel-free stainless steel extract, 316L stainless steel extract, gold alloy extract, lead material extract (positive control) and RPMI1640 medium (negative control) were added respectively. After 1, 2 and 3 days of culture, cell morphology was observed. The absorbance value in each group was determined using MTT assay. The relative cell proliferation rate was calculated. Toxicity grading was evaluated. In the simulated oral environment, the eletric potential of corrosion, current density of corrosion and polarization resistance of BIOSSN4 no-nickel stainless steel, 316L stainless steel and gold alloy were determined.

RESULTS AND CONCLUSION: Within 3 days of culture, in lead material extract group, cells shrunk; the number of cells significantly reduced; the relative growth rate was lower than that in the other four groups (P < 0.05). In the other four groups, the cell morphology was good, and the relative growth rate was over 75%. The toxicity of BIOSSN4 nickel-free stainless steel extract, 316L stainless steel extract and gold alloy extract was grade 1. The toxicity of lead material extract was grades 2-3. These results demonstrate that BIOSSN4 nickel-freestainless steel has good biocompatibility. The corrosion resistance of BIOSSN4 nickel-free stainless steel is higher than that of the 316L stainless steel but lower than that of the gold alloys.
中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Stainless Steel, Cytotoxicity, Immunologic, Corrosion, Tissue Engineering

Liu Ying, Zhang Wen-jun, Han Xue-song, Zhan De-song. Biocompatibility of a new medical nickel-free stainless steel[J]. Chinese Journal of Tissue Engineering Research, 2015, 19(47): 7608-7612.

Figures/Tables 7

References

[1] 孙皎.近五年我国口腔材料的研究概况[J].口腔材料器械杂志, 2014,23(1):1-8.

[2] 浦素云.金属植入材料及其腐蚀[M].北京:北京航空航天大学出版社,1990:23．

[3] 俞耀庭,张兴栋.生物医用材料[M].天津:天津大学出版社,2000.

[4] 赵兴伟,王景彦.生物材料在骨科临床中的应用[J].中国骨伤, 2004,17(10):6361.

[5] 马春.2005年世界新材料研究进展[J].新材料产业,2006,8(1):58.

[6] Li M,Yin T,Wang Y,et al.Study of biocompatibility of medical grade high nitrogen nickel-free austenitic stainless steel in vitro.Mater Sci Eng C Mater Biol Appl.2014;43:641-648.

[7] 章凡玉.金属植入材料在假体应用方面的研究进展[J].生物技术世界,2015,9(8):109.

[8] 张文毓.生物医用钛合金的研究进展[J].化学与黏合,2014,36(5): 369-373.

[9] 赵鹃,朱智敏,陈孟诗.深冷处理技术对口腔中熔铸造合金耐磨性的影响[J].华西口腔医学杂志,2003,21(3):184-186.

[10] Pickford MA,Scamp T,Harrison DH.Morbidity after gold weight insertion into the upper eyehd in facial palsy.Br J Plast Surg. 1992;45:460.

[11] Beddoes J,Bucci K.The influence of surface condition on the localized corrosion of 316L stainless steel orthopaedic implants. J Mater in Med.1999;10:389.

[12] Guan J,Guo L,Fu Y,et al.In vitro evaluation of antibacterial activity and cytocompatibility of antibacterial stainless steel containing copper.Sheng Wu Yi Xue Gong Cheng Xue Za Zhi.2013;30(2):333-337.

[13] Black J, Hastings G.Handbook of Biomaterial Properties. London:ChapmanHall,1999:89-90.

[14] Mc Ginley EL,Moran GP,Fleming GJ.Biocompatibility effects of indirect exposure of base-metal dental casting alloys to a human-derived three-dimensional oral mucosal model.J Dent.2013;41(11):1091-1100.

[15] 夏其升.不同种类的金属内冠烤瓷牙对形成龈缘黑线影响的观察[J].淮海医药,2015,33(5):474.

[16] 刘月,王晓萍,吴斌,等.口腔金属修复体所致过敏性疾病的临床研究[J].口腔颌面外科杂志,2013,23(6):427-431.

[17] 王耘涛，布茂东.低镍和无镍奥氏体不锈钢的研究现状及进展[J].金属热处理,2013,38(1):15-20.

[18] 任伊宾.医用高氮无镍不锈钢的研究及应用现状[J].新材料产业, 2015,17(7):44-49.

[19] 石涛,战德松,李振春.Caspase-3表达强度评价新型医用高氮无镍奥氏体不锈钢的生物相容性[J].口腔医学研究,2013,29(4): 308-311.

[20] 滕莹雪,郑丰,张炳春,等.一种无镍不锈钢冠脉支架的设计与加工工艺[J].中国医疗器械杂志,2012,36(5):354-356.

[21] Ren YB,Yang K,Zhang BC et al.Chinese Patement; NO:03110896. 2

[22] 罗璇,战德松.3种齿科合金材料浸提液对L929细胞Bcl-2表达影响的研究[J].口腔医学,2012,32(11):653-655.

[23] Uggowitzer PJ,Magdowski R.Niekel freehigh Nitrogen austenitic steels.ISIJ Tnt.1996;36(7):901-908.

[24] Brown BH,Smallwood RH,Barber DC,et al.Medical Physics and Biomedical Engineering.Bristol and Philadel Phia:Institute of Physics,1999:121.

[25] Rach J,Halter B,Aufderheide M.Importance of material evaluation prior to the construction of devices for in vitro techniques.Exp Toxicol Pathol.2013;65(7-8):973-978.