Biocompatibility research of true bone ceramics_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

QIAO Wei , REN Xiaoqi , SHI Hao , LI Jing , YANG Ting , MA Shaoying , ZHAO Yaping , SU Chengzhong ,  LI Baoxing

Shanxi Province Tissue Bank of China Institute for Radiation Protection, Shanxi Osteorad Biomaterial Co. Ltd, Taiyuan Shanxi, 030006, P.R.China;

Corresponding author：

LI Baoxing, Email: zypsir@qq.com

Keywords：

True bone ceramics; cytotoxicity; biocompatibility

DOI：

10.7507/1002-1892.201705001

Video：

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Objective To investigate the biocompatibility of true bone ceramic (TBC) and provide experimental basis for clinic application. Methods TBC was prepared from healthy adult bovine cancellous bone by deproteinization and high temperature calcinations. Mouse fibroblast cell line (L929 cells) were cultured with the leaching liquor of TBC in vitro, and the cytotoxicity was evaluated at 2nd, 4th, and 7th days. L929 cells were inoculated into the TBC and cultured for 4 days. The cell adhesion and proliferation on the surface of the TBC were observed by scanning electron microscopy, and evaluated the cell compatibility of TBC. Ten New Zealand white rabbits were divided into 2 groups, and drilled holes at the tibia of both hind limbs. TBC and hydroxyapatite (HA) were implanted into the left side (experimental group) and the right side (control group), respectively. And the biocompatibility of TBC was evaluated by general observation and histological observation at 4 and 26 weeks after implantation. Results Cytotoxicity test showed that the cytotoxicity level of leaching liquor of TBC was grade 0-1. Cell compatibility experiments showed that the L929 cells adhered well on the surface of TBC and migrated into the pores. The implantation test in vivo showed that experimental group and control group both had mild or moderate inflammatory response at 4 weeks, and new bone formation occurred. At 26 weeks, there was no inflammatory reaction observed in both groups, and new bone formation was observed in varying degrees. Conclusion TBC have good biocompatibility and can be used to repair bone defect in clinic.

Citation： QIAO Wei, REN Xiaoqi, SHI Hao, LI Jing, YANG Ting, MA Shaoying, ZHAO Yaping, SU Chengzhong, LI Baoxing. Biocompatibility research of true bone ceramics. Chinese Journal of Reparative and Reconstructive Surgery, 2017, 31(10): 1250-1255. doi: 10.7507/1002-1892.201705001 Copy

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2.	Johansson B, Grepe A, Wannfors K, et al. A clinical study of changes in the volume of bone grafts in the atrophic maxilla. Dento Maxillo Facial Radiology, 2001, 30(3): 157-161.
3.	Young M, Carter D, Worthington H, et al. Microbial analysis of bone collected during implant surgery: a clinical and laboratory study. Clinical Oral Implants Research, 2001, 12(2): 95-103.
4.	康非吾, 唐休发, 温玉明, 等. 骨生物衍生支架材料组织相容性实验研究. 口腔颌面外科杂志, 2005, 15(3): 223-226.0.
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7.	Hollinger JD, Battistone GC. Biodegradable bone repair materials. Synthetic polymers and ceramics. Clin Orthop Relat Res, 1986, (207): 290-305.
8.	Lee HR, Kim HJ, Ko JS, et al. Comparative Characteristics of Porous Bioceramics for an Osteogenic Response In Vitro and In Vivo. PLoS One, 2013, 8(12): e84272.
9.	郭风劲, 王泰仪, 孙淑珍. 不同条件锻烧牛骨物理性能差异分析. 医用生物力学, 2001, 16(1): 23-26.0.
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16.	江捍平, 王大平, 阮建明, 等. 纳米羟基磷灰石人工骨的生物相容性研究. 中国现代医学杂志, 2005, 15(10): 1477-1480.0.
17.	王世惟, 裴庆国, 宋萌. 骨髓基质干细胞与 β-TCP 生物相容性的实验研究. 上海口腔医学, 2010, 19(3): 319-321.0.
18.	Šponer P, Strnadová M, Urban K. In vivo behaviour of low-temperature calcium-deficient hydroxyapatite: comparison with deproteinised bovine bone. International Orthopaedics, 2011, 35(10): 1553-1560.
19.	罗卓荆, 胡蕴玉, 王茜, 等. 异种松质骨移植抗原分布的免疫组化研究. 中国矫形外科杂志, 1998, 5(6): 539-540.0.
20.	Iwata M, Nishijima K. Experimental study of two-step grafting of fetal bone: comparison with newborn bone and influence of MHC. Transplantation Proceedings, 1994, 26(2): 959-962.
21.	赵文博, 张智, 阳波, 等. 异种骨移植与大段骨缺损修复现状及研究进展. 现代临床医学, 2016, 42(4): 245-248.0.
22.	刘斌钰, 马晓红, 李宁毅, 等. 煅烧骨的生物相容性及细胞相容性评价. 中国组织工程研究与临床康复, 2008, 12(41): 8055-8058.0.
23.	郑启新, 刘苏南. 煅烧牛松质骨的制备、理化性能及生物相容性研究. 生物医学工程学杂志, 2005, 22(1): 95-98.0.
24.	高媛, 孔丽君, 王晨, 等. 牛煅烧骨的表征及其对成骨细胞的作用. 生物物理学报, 2004, 20(6): 483-488.0.
25.	许永华, 施新猷, 胡蕴玉, 等. 牛煅烧骨与体外培养兔骨膜成骨细胞的相容性. 第四军医大学学报, 2000, 21(4): 512-514.0.
26.	Li JF, Zheng QX, Guo XD, et al. Bone induction by surface-double-modified true bone ceramics In Vitro and In Vivo. Biomedical Material, 2013, 3(8): 4690-4701.
27.	Meyer S, Floerkemeier T, Windhagen H. Histological osseointegration of Tutobone: first results in human. Arch Orthop Trauma Surg, 2008, 128(6): 539-544.
28.	Briem D, Linhart W, Lehmann W, et al. Long-term outcomes after using porous hydroxyapatite ceramics (Endobon) for surgical management of fractures of the head of the tibia. Unfallchirurg, 2002,105(2): 128-133.
29.	何越, 田智泉, 王亮, 等. 天然煅烧骨修复材料(骼瑞)修复动物骨缺损的有效性研究. 实用口腔医学杂志, 2015, 31(2): 167-170.0.

1. Lane J, Tomin E, Bostrom M. Biosynthetic bone grafting. Clin Orthop Relat Res, 1999, (367): 107-117.
2. Johansson B, Grepe A, Wannfors K, et al. A clinical study of changes in the volume of bone grafts in the atrophic maxilla. Dento Maxillo Facial Radiology, 2001, 30(3): 157-161.
3. Young M, Carter D, Worthington H, et al. Microbial analysis of bone collected during implant surgery: a clinical and laboratory study. Clinical Oral Implants Research, 2001, 12(2): 95-103.
4. 康非吾, 唐休发, 温玉明, 等. 骨生物衍生支架材料组织相容性实验研究. 口腔颌面外科杂志, 2005, 15(3): 223-226.0.
5. 何钟勤, 高心, 田小华, 等. 煅烧骨颗粒大小对兔颅骨缺损引导成骨作用的影响. 吉林大学学报 (医学版), 2012, 38(1): 75-78.0.
6. Gong TF, Xia RY, Yang CH, et al. Study of gelatinized marrow stroma osteoblasts and true bone ceramic active bone. Chinese Journal of Traumatology, 2005, 8(2): 91-95.
7. Hollinger JD, Battistone GC. Biodegradable bone repair materials. Synthetic polymers and ceramics. Clin Orthop Relat Res, 1986, (207): 290-305.
8. Lee HR, Kim HJ, Ko JS, et al. Comparative Characteristics of Porous Bioceramics for an Osteogenic Response In Vitro and In Vivo. PLoS One, 2013, 8(12): e84272.
9. 郭风劲, 王泰仪, 孙淑珍. 不同条件锻烧牛骨物理性能差异分析. 医用生物力学, 2001, 16(1): 23-26.0.
10. 董玉峰, 侯希敏. 天然多孔活性煅烧骨的制备及动物实验研究. 中国矫形外科杂志, 1997, 4(4): 315-316.0.
11. 吴平. 谈实施 GB/T16886.1-1997-ISO10993-1 标准应注意的问题. 中国标准化, 2001(8): 10-12.0.
12. 国家药品监督管理局. 医疗器械生物学评价第 5 部分: 体外细胞毒性试验. 北京: 中国标准出版社, 2003: 81-88.
13. 国家食品药品监督管理局. 医疗器械生物学评价第 12 部分: 样品制备与参照样品. 北京: 中国标准出版社, 2005: 1-10.
14. 国家食品药品监督管理局. 医用有机硅材料生物学评价实验方法. 北京: 中国标准出版社, 2008: 1-30.
15. 国家医药管理局. 医疗器械生物学评价第 6 部分: 植入后局部反应试验. 北京: 中国标准出版社, 1997: 1-8.
16. 江捍平, 王大平, 阮建明, 等. 纳米羟基磷灰石人工骨的生物相容性研究. 中国现代医学杂志, 2005, 15(10): 1477-1480.0.
17. 王世惟, 裴庆国, 宋萌. 骨髓基质干细胞与 β-TCP 生物相容性的实验研究. 上海口腔医学, 2010, 19(3): 319-321.0.
18. Šponer P, Strnadová M, Urban K. In vivo behaviour of low-temperature calcium-deficient hydroxyapatite: comparison with deproteinised bovine bone. International Orthopaedics, 2011, 35(10): 1553-1560.
19. 罗卓荆, 胡蕴玉, 王茜, 等. 异种松质骨移植抗原分布的免疫组化研究. 中国矫形外科杂志, 1998, 5(6): 539-540.0.
20. Iwata M, Nishijima K. Experimental study of two-step grafting of fetal bone: comparison with newborn bone and influence of MHC. Transplantation Proceedings, 1994, 26(2): 959-962.
21. 赵文博, 张智, 阳波, 等. 异种骨移植与大段骨缺损修复现状及研究进展. 现代临床医学, 2016, 42(4): 245-248.0.
22. 刘斌钰, 马晓红, 李宁毅, 等. 煅烧骨的生物相容性及细胞相容性评价. 中国组织工程研究与临床康复, 2008, 12(41): 8055-8058.0.
23. 郑启新, 刘苏南. 煅烧牛松质骨的制备、理化性能及生物相容性研究. 生物医学工程学杂志, 2005, 22(1): 95-98.0.
24. 高媛, 孔丽君, 王晨, 等. 牛煅烧骨的表征及其对成骨细胞的作用. 生物物理学报, 2004, 20(6): 483-488.0.
25. 许永华, 施新猷, 胡蕴玉, 等. 牛煅烧骨与体外培养兔骨膜成骨细胞的相容性. 第四军医大学学报, 2000, 21(4): 512-514.0.
26. Li JF, Zheng QX, Guo XD, et al. Bone induction by surface-double-modified true bone ceramics In Vitro and In Vivo. Biomedical Material, 2013, 3(8): 4690-4701.
27. Meyer S, Floerkemeier T, Windhagen H. Histological osseointegration of Tutobone: first results in human. Arch Orthop Trauma Surg, 2008, 128(6): 539-544.
28. Briem D, Linhart W, Lehmann W, et al. Long-term outcomes after using porous hydroxyapatite ceramics (Endobon) for surgical management of fractures of the head of the tibia. Unfallchirurg, 2002,105(2): 128-133.
29. 何越, 田智泉, 王亮, 等. 天然煅烧骨修复材料(骼瑞)修复动物骨缺损的有效性研究. 实用口腔医学杂志, 2015, 31(2): 167-170.0.

Chinese Journal of Reparative and Reconstructive Surgery

Biocompatibility research of true bone ceramics

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