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, 唐休發, 溫玉明, 等. 骨生物衍生支架材料組織相容性實驗研究. 口腔頜面外科雜志, 2005, 15(3): 223-226.0.
5.	何鐘勤, 高心, 田小華, 等. 煅燒骨顆粒大小對兔顱骨缺損引導成骨作用的影響. 吉林大學學報 (醫學版), 2012, 38(1): 75-78.0.
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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.	郭風勁, 王泰儀, 孫淑珍. 不同條件鍛燒牛骨物理性能差異分析. 醫用生物力學, 2001, 16(1): 23-26.0.
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14.	國家食品藥品監督管理局. 醫用有機硅材料生物學評價實驗方法. 北京: 中國標準出版社, 2008: 1-30.
15.	國家醫藥管理局. 醫療器械生物學評價第 6 部分: 植入后局部反應試驗. 北京: 中國標準出版社, 1997: 1-8.
16.	江捍平, 王大平, 阮建明, 等. 納米羥基磷灰石人工骨的生物相容性研究. 中國現代醫學雜志, 2005, 15(10): 1477-1480.0.
17.	王世惟, 裴慶國, 宋萌. 骨髓基質干細胞與 β-TCP 生物相容性的實驗研究. 上海口腔醫學, 2010, 19(3): 319-321.0.
18.	?poner 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.	羅卓荊, 胡蘊玉, 王茜, 等. 異種松質骨移植抗原分布的免疫組化研究. 中國矯形外科雜志, 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.	趙文博, 張智, 陽波, 等. 異種骨移植與大段骨缺損修復現狀及研究進展. 現代臨床醫學, 2016, 42(4): 245-248.0.
22.	劉斌鈺, 馬曉紅, 李寧毅, 等. 煅燒骨的生物相容性及細胞相容性評價. 中國組織工程研究與臨床康復, 2008, 12(41): 8055-8058.0.
23.	鄭啟新, 劉蘇南. 煅燒牛松質骨的制備、理化性能及生物相容性研究. 生物醫學工程學雜志, 2005, 22(1): 95-98.0.
24.	高媛, 孔麗君, 王晨, 等. 牛煅燒骨的表征及其對成骨細胞的作用. 生物物理學報, 2004, 20(6): 483-488.0.
25.	許永華, 施新猷, 胡蘊玉, 等. 牛煅燒骨與體外培養兔骨膜成骨細胞的相容性. 第四軍醫大學學報, 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. 天然煅燒骨修復材料(骼瑞)修復動物骨缺損的有效性研究. 實用口腔醫學雜志, 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, 唐休發, 溫玉明, 等. 骨生物衍生支架材料組織相容性實驗研究. 口腔頜面外科雜志, 2005, 15(3): 223-226.0.
5. 何鐘勤, 高心, 田小華, 等. 煅燒骨顆粒大小對兔顱骨缺損引導成骨作用的影響. 吉林大學學報 (醫學版), 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. 郭風勁, 王泰儀, 孫淑珍. 不同條件鍛燒牛骨物理性能差異分析. 醫用生物力學, 2001, 16(1): 23-26.0.
10. 董玉峰, 侯希敏. 天然多孔活性煅燒骨的制備及動物實驗研究. 中國矯形外科雜志, 1997, 4(4): 315-316.0.
11. 吳平. 談實施 GB/T16886.1-1997-ISO10993-1 標準應注意的問題. 中國標準化, 2001(8): 10-12.0.
12. 國家藥品監督管理局. 醫療器械生物學評價第 5 部分: 體外細胞毒性試驗. 北京: 中國標準出版社, 2003: 81-88.
13. 國家食品藥品監督管理局. 醫療器械生物學評價第 12 部分: 樣品制備與參照樣品. 北京: 中國標準出版社, 2005: 1-10.
14. 國家食品藥品監督管理局. 醫用有機硅材料生物學評價實驗方法. 北京: 中國標準出版社, 2008: 1-30.
15. 國家醫藥管理局. 醫療器械生物學評價第 6 部分: 植入后局部反應試驗. 北京: 中國標準出版社, 1997: 1-8.
16. 江捍平, 王大平, 阮建明, 等. 納米羥基磷灰石人工骨的生物相容性研究. 中國現代醫學雜志, 2005, 15(10): 1477-1480.0.
17. 王世惟, 裴慶國, 宋萌. 骨髓基質干細胞與 β-TCP 生物相容性的實驗研究. 上海口腔醫學, 2010, 19(3): 319-321.0.
18. ?poner 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. 羅卓荊, 胡蘊玉, 王茜, 等. 異種松質骨移植抗原分布的免疫組化研究. 中國矯形外科雜志, 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. 趙文博, 張智, 陽波, 等. 異種骨移植與大段骨缺損修復現狀及研究進展. 現代臨床醫學, 2016, 42(4): 245-248.0.
22. 劉斌鈺, 馬曉紅, 李寧毅, 等. 煅燒骨的生物相容性及細胞相容性評價. 中國組織工程研究與臨床康復, 2008, 12(41): 8055-8058.0.
23. 鄭啟新, 劉蘇南. 煅燒牛松質骨的制備、理化性能及生物相容性研究. 生物醫學工程學雜志, 2005, 22(1): 95-98.0.
24. 高媛, 孔麗君, 王晨, 等. 牛煅燒骨的表征及其對成骨細胞的作用. 生物物理學報, 2004, 20(6): 483-488.0.
25. 許永華, 施新猷, 胡蘊玉, 等. 牛煅燒骨與體外培養兔骨膜成骨細胞的相容性. 第四軍醫大學學報, 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. 天然煅燒骨修復材料(骼瑞)修復動物骨缺損的有效性研究. 實用口腔醫學雜志, 2015, 31(2): 167-170.0.

Chinese Journal of Reparative and Reconstructive Surgery

Biocompatibility research of true bone ceramics

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