可吸收内固定PLLA材料制备及生物相容性评价  

Preparation and biocompatibility evaluation of absorbable internal fixed PLLA material

作　　者：钟华[1] 刘建纯[1] 郭乐斌[1] 胡斌[1] Zhong Hua;Liu Jianchun;Guo Lebin;Hu Bin(Department of Orthopedics,Yiyang Central Hospital,Yiyang 413000,China)

机构地区：[1]益阳市中心医院骨科,413000

出　　处：《国际医药卫生导报》2018年第8期1133-1139,共7页International Medicine and Health Guidance News

基　　金：湖南省医药卫生科研计划项目（B2016188）

摘　　要：目的 评估PLLA可吸收材料制备的椎弓根钉棒系统的材料特性及生物相容性。方法 以L-乳酸为原料，采用开环聚合法制备合适的粘均分子量的L-聚乳酸（PLLA），并模压成型，制备PLLA椎弓根钉棒系统。通过相关物理性质检测及pH值改变分析其体外降解特性；进一步将PLLA合成材料浸提液与成骨细胞共培养，MTT法及PI/hochest法测定PLLA材料对细胞增殖及凋亡的影响；测定碱性磷酸酶含量，分析其对成骨细胞分化的影响；并行材料过敏试验及全身急性毒性实验，明确PLLA内固定材料与动物组织的相容性。结果 PLLA内固定材料对共培养的成骨细胞Mc3T3-E1的增殖、凋亡及成骨分化中无明显影响，体外验证其无明显细胞毒性。PLLA内固定材料处理小鼠后，其生长正常，未导致动物死亡或引起较大的系统毒性；体内植入实验显示，未见炎性组织及脓性分泌物。结论 PLLA可吸收材料具有良好的生物相容性且无明显的细胞毒性，已达到生物安全性初级检测及临床应用前试验的要求，作为传统金属材料内固定的替代有着广阔前景。Objective To evaluate the properties and biocompatibility of the pedicle screw-rod system made by absorbable Poly L-Lactic Acid(PLLA)material.Methods Using L-lactic acid as raw material,we adopted ring-opening polymerization method to make appropriate viscosity-average molecular weight PLLA for compression molding and preparation of the screw-rod system of the pedicle of vertebral arch.To analyze the degradation characteristics in vitro through detection of related physical properties and changes of pH value,we co-cultured PLLA extracts and osteoblasts to observe the influence of PLLA to osteoblasts proliferation and apoptosis by MTT method and PI/hochest method,determine the contents of alkaline phosphatase to the influence on the differentiation of osteoblasts,to test allergy and acute systemic toxicity,and compatibility of PLLA internal fixation material with animal tissues.Results There was no remarkable influence of PLLA on proliferation,apoptosis,and osteogenic differentiation of the co-cultured Mc3T3-E1 osteoblasts of mice.No cytotoxicity had been found in vitro.After treated with PLLA in mice,the growth was normal without causing death or systemic toxicity.In vivo implantation experiments,it showed no inflammatory tissue and purulent secretion.Conclusions PLLA absorbable material has good biocompatibility and no cytotoxicity.It meets the requirements of primary detection and preclinics in biosafety as a substitute for traditional metal material with broad prospects.

关 键 词：L-聚乳酸 可降解材料 生物相容性 大鼠 

分 类 号：R318.08[医药卫生—生物医学工程]