双相磷酸钙/聚乳酸复合生物材料的生物相容性  

Biocompatibility of biphasic calcium phosphate/poly L-lactic acid composite material

作　　者：吴亭熹[1] 杨为中[2] 李亚东[3] 张虎军[3] 陈林红[2] 周大利[2] 尹光福[2] 

机构地区：[1]四川大学华西口腔医学院,四川省成都市610041 [2]四川大学材料科学与工程学院,四川省成都市610064 [3]解放军成都军区总医院,四川省成都市610083

出　　处：《中国组织工程研究与临床康复》2009年第21期4025-4028,共4页Journal of Clinical Rehabilitative Tissue Engineering Research

基　　金：国家863计划项目(2002AA326080);教育部博士点基金项目(20060610024)~~

摘　　要：背景:双相磷酸钙生物陶瓷与聚乳酸复合材料具有优良的生物活性和生物降解性。适宜孔隙结构的双相磷酸钙具有骨诱导性能,故与目前广泛报道的羟基磷灰石/聚乳酸相比,可望成为一类有前途的骨缺损修复材料。目的:制备双相磷酸钙/聚乳酸复合材料并对其生物相容性进行体内及体外评价。设计、时间及地点:动物观察,生物相容性实验,于2008-03/12在四川大学材料科学与工程学院及四川大学华西口腔医学院完成,部分检测在解放军成都军区总医院完成。材料:以溶液浇铸/粒子沥滤法制备多孔双相磷酸钙/聚乳酸复合材料。方法:以肌内植入实验、致敏实验、皮肤刺激实验、急性毒性实验、短期毒性实验验证复合材料的生物相容性。主要观察指标:复合材料孔隙结构及抗压强度、肌内植入组织学切片观察、急性毒性及短期全身毒性评级、致敏实验分级、皮肤刺激计分。结果:双相磷酸钙/聚乳酸复合材料无急性毒性作用对皮肤无刺激性、无短期全身毒性。复合材料孔径为200～400μm且相互贯通,具有适宜的孔隙结构及力学强度。结论:双相磷酸钙/聚乳酸复合材料具有优良的生物相容性。BACKGROUND： Biphasic calcium phosphate （BCP）/poly L-lactic acid （PLLA） composite material has good bioactivity and bio-degradation. BCP with proper porous structure has an osteo-inductivity. Compared with the well-reported hydroxyapatite （HA）/PLLA, BCP/PLLA composite is expected to be a promising bone repairing material. OBJECTIVE： To prepare BCP/PLLA composite and evaluate its biocompatibility. DESIGN, TIME AND SETTING： Material preparation and animal experiment was performed in College of Materials Science and Engineering, Sichuan University and West China College of Stomatology, Sichuan University from March and December 2008. Some tests were performed in General Hospital of Chengdu Military Area Command of Chinese PLA. MATERIALS： BCP/PLLA composite with porous structure was prepared using solvent casting/particulate leaching technique. METHODS： The biocompatibility of the material was evaluated by implantation in muscle, dermal sensitization, acute systemic toxicity experiment, short term systemic toxicity experiment and skin stimulus experiment. MAIN OUTCOME MEASURES： Porous structure and compressive strength of the composite; histological observations after implantation in muscle pouches; the rank score of acute systemic toxicity test and short term systemic toxicity experiment; the classification of dermal sensitization test; the score of skin stimulus experiment. RESULTS： The composite material did not have acute toxicity, skin stimulation, and short term systemic toxicity. In addition, the composite material possessed a suitable porous structure （200～400 μm） and mechanical strength. CONCLUSION： The composite material has well biocompatibility.

关 键 词：生物相容性 生物材料 双相磷酸钙 聚乳酸 复合材料 

分 类 号：R318[医药卫生—生物医学工程]