新型可注射可降解磷酸钙骨水泥的生物相容性

背景：体外实验已证实新型磷酸钙骨水泥有良好的可注射性、力学性能、抗溃散性及体外降解性能。 目的：验证新型可注射、可降解磷酸钙骨水泥的生物相容性。 方法：①急性毒性实验：分别向昆明小鼠尾静脉可注射新型磷酸钙骨水泥浸提液与生理盐水。②热源实验：在新西兰兔耳缘静脉注射新型磷酸钙骨水泥浸提液。③溶血实验：在兔抗凝血分别加入新型磷酸钙骨水泥浸提液、生理盐水及双蒸水。④迟发型超敏反应实验：在豚鼠肩胛骨内侧部位分别注射可注射新型磷酸钙骨水泥浸提液与生理盐水，并进行敷贴激发实验。⑤体外细胞毒性实验：在L929系小鼠成纤维细胞株培养液中分别加入可注射新型磷酸钙骨水泥浸提液、聚乙烯浸提液及苯酚溶液。⑥微核实验：分别在昆明小鼠腹腔注射可注射新型磷酸钙骨水泥浸提液、生理盐水与环磷酰胺。⑦肌肉植入实验：将新型磷酸钙骨水泥植入新西兰兔脊柱两侧肌肉内。 结果与结论：新型可注射磷酸钙骨水泥无毒，无刺激性及致敏性，无热源反应，具有良好的血液相容性，植入动物肌肉后为非组织刺激物，具有良好的生物相容性，因而具有较好的生物安全性。

Biocompatibility of a novel injectable and degradable calcium phosphate cement

BACKGROUND: A novel calcium phosphate bone cement has been proved to have good injectability, biomechanical properties, anti-collapsibility and in vitro degradability. OBJECTIVE: To evaluate the biocompatibility of a novel injectable and degradable calcium phosphate cement. METHODS: (1) In acute toxicity test, cement extracts were applied to mice by tail vein injection. (25) In pyrogen test, extracts were applied to rabbits by mainline. (3) In hemolysis test, extracts were added in the fresh anticoagulant blood of rabbits. (4) In delayed-type hypersensitivity test, two steps, induced and aroused were applied to guinea pigs. (5) In cytotoxicity test in vitro, extracts of cement, polyethylene, and phenol were added in L929 cells to evaluate cytotoxicity. (6) In mammal micronucleus test, extracts, normal saline and cyclophosphamide were applied to mice by intraperitoneal injection. (7) In muscular implantation test, muscle specimens were histologically evaluated. RESULTS AND CONCLUSION:The cement-extracted liquid induced no acute toxicity in mice, no pyrogenic reaction in rabbits, no genetic toxicity in mice or allergic reaction in guinea pigs. This novel cement had a great biocompatibility and biological safety.