氨基酸聚合物复合硫酸钙材料的体内生物相容性  

In vivo biocompatibility of multi-(amino acid) copolymer-calcium sulfate

作　　者：朱建伟[1] 杨晓波[1] 沈彬[1] 杨静[1] 周宗科[1] 裴福兴[1] 

机构地区：[1]四川大学华西医院骨科,四川省成都市610041

出　　处：《中国组织工程研究与临床康复》2010年第51期9572-9576,共5页Journal of Clinical Rehabilitative Tissue Engineering Research

基　　金：国家科技部支撑计划项目(2007BAE13B04)~~

摘　　要：背景:氨基酸聚合物是一种新型的生物工程材料,具有多种优点,临床应用前景广阔。但现阶段针对此种新型材料的体内试验研究数据仍十分有限。目的:采用动物体内实验的方法,评价新型生物工程材料氨基酸聚合物复合硫酸钙的体内相容性。方法:将多元氨基酸聚合物与硫酸钙进行复合制备成多孔复合材料及其浸提液,进行以下实验:①全身急性毒性实验,10只SD大鼠分为两组,腹腔注射材料浸提液或生理盐水,观察记录1周内大鼠的活动及生长情况。②慢性毒性实验,材料植入新西兰兔背部肌肉,观察术后1,4,8周肝肾功能变化。③皮内刺激实验,5只新西兰大白兔背部皮内注射材料浸提液,观察注射部位红斑、水肿出现情况。④肌肉植入实验,材料植入新西兰兔背部肌肉,术后1,2,4,6,8周取材,观察材料与周围组织反应情况。结果与结论:①急性毒性实验显示大鼠注射材料浸提液后活动正常,两组大鼠体质量均呈上升趋势,且体质量增加率比较差异无显著性意义(P>0.05)。②新西兰兔背部肌肉材料植入后未见明显肝肾功能损害。③皮内刺激实验显示新西兰兔背部浸提液注射部位未出现红斑、水肿等刺激反应情况。④新西兰兔肌肉植入实验显示材料周围炎症反应轻微,包膜逐渐吸收,未见排斥反应。植入材料周边肌细胞的细胞色素氧化酶和乳酸脱氢酶等酶活性在各时间点均无明显减弱。结果提示新型材料氨基酸聚合物复合硫酸钙具有良好的体内安全性和相容性,在体内能够很好的降解、吸收,可望用作骨修复材料。BACKGROUND：Amino acid polymer is a kind of new biological engineering materials,it has many advantages and potential application prospect in clinical field.However,the in vivo experiment study of this material is limited.OBJECTIVE：To evaluate the biocompatibility of a novel biological engineering material,multi-（amino acid） copolymer-calcium sulfate compound,through animal experiments.METHODS：The multi-（amino acid） copolymer was compounded with calcium sulfate to prepare porous composite material and its diffusion solution.The following tests were performed：Acute general toxicity test：Two groups of SD rats （n=10） received peritoneal injection of diffusion solution and saline,respectively.Change of activity and rat weight within 1 week were documented.Chronic toxicity test：The changes of liver and kidney functions were observed after composite materials were implanted into back muscles of New Zealand rabbits.Intradermal stimulation test：The stimulations such as erythema and edema were observed after the diffusion solution was intradermally injected into the back skin of New Zealand rabbits.Intramuscular implantation test：The composite materials were implanted into musculus sacrospinalis of New Zealand rabbits.The tissue reactions were observed at 1,2,4,8 weeks.RESULTS AND CONCLUSION：In the acute general toxicity test,the diary activities of rates were normal after the injection of the diffusion solution.Rat body weight was growing similarly in both groups,the increase rate of body weight had no significant difference （P0.05）.There were no significant damages of rabbits＇ liver and kidney functions after implantation of materials into animal muscle.In intradermal stimulation test,skin reactions such as erythema and edema were not observed after the injection of diffusion solution into rabbits.In intramuscular implantation test,the reaction of inflammatory cells of the tissue nearby implants was slight,the fibrous tissue and blood vessels grew into the composite materials,without r

关 键 词：氨基酸 聚合物 硫酸钙 体内相容性 骨修复材料 

分 类 号：R318[医药卫生—生物医学工程]