首页|可注射含钙骨基质材料的制备及骨修复评价

可注射含钙骨基质材料的制备及骨修复评价

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目的 制备一种可注射含钙骨基质(injectable calcium-containing bone matrix,ICBM),评价其骨修复效果,并分析用于临床治疗的可行性.方法 将甘油和明胶作为赋型剂,与其制备的含钙骨基质(calcium-containing bone matrix,CBM)粉进行混合,得到 ICBM;通过测定骨粉、赋型剂和 ICBM 的 pH 值、钙含量,以及赋型剂、ICBM 的注射推力情况,对 ICBM 进行初步表征;通过体外 L929 细胞增殖实验对 ICBM 进行体外生物相容性评价;在昆明小鼠和白化豚鼠体内分别植入 ICBM 评价其体内安全性;进一步用裸鼠进行体内骨诱导验证;最后采用兔股骨髁缺损模型进行体内骨缺损修复,评价 ICBM 的有效性.结果 骨粉 pH 值为 6.51±0.32、钙含量为(26.24±1.25)%;赋型剂 pH 值为 5.56±0.28,注射推注力为(1.23±0.16)N;ICBM pH 值为 6.44±0.47,钙含量为(5.32±0.73)%,注射推注力为(10.87±1.53)N.ICBM 组细胞相对增殖率为(104.25±3.39)%,细胞毒性为 0 级;ICBM 未对昆明小鼠产生急性全身毒性反应,也未引起白化豚鼠发生迟发型超敏反应;在体内骨诱导组织学观察发现 ICBM 组可见大量有明显成骨出现;在兔股骨髁缺损修复 8 周时,脱钙骨基质(demineralized bone matrix,DBM)组缺损修复面积为(12.91±2.27)%,ICBM 组为(15.68±2.25)%,两组缺损修复面积差异有统计学意义(P<0.05).结论 制备一种 ICBM,使 CBM 具有注射可操作性同时不影响其成骨诱导活性,不仅使用方便,安全性高,还具有较高的临床推广应用价值.
Preparation of the injectable calcium-containing bone matrix material and evaluation of its bone repair
Objective To prepare an injectable calcium-containing bone matrixs(ICBM)and evaluate its bone repair,as well as its possibility of clinical application.Methods Glycerol and gelatin were used to prepare the excipient,and then mixed with the prepared CBM powder to obtain the ICBM.The pH and calcium content of bone powder,excipient and ICBM were tested;injection thrust of excipient and ICBM were measured;all data above were used to perform the preliminary characterization of the ICBM.The biocompatibility of ICBM was evaluated by in vitro cell proliferation experiment.ICBM was implanted into Kunming mice and albino guinea pigs to evaluate the in vivo safety.Further,bone induction in vivo was verified in nude mice.Finally,rabbit femoral condyle defective model was used to study the effectiveness of bone defect repair.Results The pH and calcium content of bone powder was(6.51±0.32)and(26.24±1.25)%;the pH and injection thrust of excipient was(5.56±0.28)and(1.23±0.16)N;the pH,calcium content and injection thrust of ICBM was(6.44±0.47),(5.32±0.73)%and(10.87±1.53)N.The relative cell proliferation rate of L929 cell for the ICBM group was(104.25±3.39)%,and the cytotoxicity rating of the ICBM was level 0.There was no acute systemic toxicity in Kunming mice,and no delayed hypersensitivety in albino guinea pigs.Histological observation of bone induction in vivo showed that the ICBM group exhibited significant osteogenic phenomena.The repaired area of rabbit femoral condyle defect at week 8 were(12.91±2.27)%in DBM group and(15.68±2.25)%in ICBM group,while the differences were statistically significant between the two groups.Conclusions An ICBM was prepared to make CBM injectable without affecting the osteogenic activity.It is easy and safe,while clinical application is recommended.

Bone matrixInjectionsOsteoinductionBone defect

郝丽芳、刘永进、韩丽伟、胡先同、衷鸿宾、李利、侯树勋、赵彦涛

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100048 北京市骨科植入医疗器械工程技术研究中心

100048 北京,中国人民解放军总医院第四医学中心骨科医学部

骨基质 注射 骨诱导 骨缺损

国家自然科学基金国家自然科学基金首都临床特色诊疗技术研究及转化应用项目北京市自然科学基金海淀前沿项目

8215131282272493Z221100007422014L212067

2024

中国骨与关节杂志
中国医疗保健国际交流促进会,北京中科康辰骨关节伤病研究所

中国骨与关节杂志

CSTPCD
影响因子:0.665
ISSN:2095-252X
年,卷(期):2024.13(1)
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