注射型可吸收聚氨基酸/硫酸钙复合材料动物体内的安全及组织相容性*☆

背景：临床上应用的聚甲基丙烯酸甲酯和磷酸钙骨水泥可注射型骨修复材料在体内不能完全降解、吸收，且成骨能力较差。 目的：评估新注射型聚氨基酸/硫酸钙复合材料在动物体内的安全性及组织相容性。 方法：将注射型聚氨基酸/硫酸钙复合材料植入新西兰兔背部肌肉内，将其浸提液分别注射至昆明小鼠体内与新西兰兔背部皮内。 结果与结论：注射材料浸提液后，小鼠一般情况良好，体质量均呈上升趋势，腹腔各脏器无明显水肿、粘连、坏死等；兔背部浸提液注射部位未出现红斑、水肿等皮内刺激反应。聚氨基酸/硫酸钙复合材料植入兔背部肌肉早期材料周围炎症反应明显，后逐渐减弱，包膜样结构逐渐被吸收，未见明显排斥反应；材料周围肌肉细胞色素氧化酶和乳酸脱氢酶等氧化相关酶活性无明显减弱。提示新型可注射复合材料在动物体内具有良好的安全性和组织相容性。

Security and biocompatibility of injectable absorbable poly amino acid/calcium sulfate composites in vivo

BACKGROUND: Injectable bone repair materials such as polymethylmethacrylateand calcium phosphate cement cannot be completely degraded or absorbed in clinical application, and both of them have poor osteogenic ability. OBJECTIVE: To evaluate the security and biocompatibility of injectable absorbable poly amino acid/calcium sulfate through animal experiments. METHODS: The composite materials were implanted into the musculus sacrospinalis of New Zealand rabbits, and the diffusion solution was injected into Kunming mice and the back skin of New Zealand rabbits, respectively. RESULTS AND CONCLUSION: The general condition of mice were good after the injection of the diffusion solution, and the body weight was increasing, without significant edema, adhesions, necrosis of intra-abdominal organs. The skin stimulation reactions such as erythema and edema were not observed after the injection of the diffusion solution into the rabbits. The inflammatory reaction around the implants was obvious after intramuscular implantation into the rabbits in the early stage, and then weakened gradually. The capsule-like structure was also absorbed gradually, and no significant rejection was observed. The activity of cytochrome oxidase and lactate dehydrogenase of muscles cells around the implants had no significant decrease after implantation. All of the above prompted that the new poly amino acid/calcium sulfate composites have good biocompatibility and excellence safety in vivo.