L/DL-聚乳酸材料的细胞相容性及其组织相容性研究

The study of the cell compatibility and biocompatibility of L/DL-poly lactic acid material

目的评价L/DL-聚乳酸材料的细胞相容性和组织相容性。方法按照GB/T16886.5-2003《医疗器械生物学评价》体外细胞毒性的实验方法进行分组:L/DL-聚乳酸材料组、纯钛组、纯铅组。体外选用L-929细胞行MTT实验和急性溶血性实验检测;体内参照GB/T16175-1996中的评价标准,选取10只新西兰大白兔,行背部短期皮下埋植实验,应用组织学切片对材料周围纤维包膜进行厚度及炎性程度分析对比。结果 MTT示,除1 d组外,阳性对照组与各浓度组间均相差显著(P<0.01)。5 d组及7 d组1%降解液与各浓度组差异均有统计学意义(P<0.05)。急性溶血性实验示,L/DL-聚乳酸材料实验溶血率为2.65%,证明该材料生物相容性良好。短期埋藏实验示,L/DL-聚乳酸材料植入后其炎性细胞及组织反应程度与纯钛金属差异无统计学意义(P>0.05),且均显著低于纯铅组(P<0.05)。结论 L/DL-聚乳酸材料具有良好的细胞相容性和组织相容性,是一种理想的生物医用材料。

Objective To eva1uate the ce11 compatibi1ity and biocompatibi1ity of L/ DL-po1y 1actic acid materia1. Methods According to the testing method of GB/ T16886. 5 2003“Bio1ogica1 Eva1uation of Medica1 Devices”,the materia1s were grouped for vitro cytotox-icity tests：L/ DL- po1y 1actic acid materia1 group,pure titanium group and pure 1ead group. L-929 ce11s were se1ected for MTT test and acute hemo1ytic test in vitro. According to GB/ T16175-1996,10 New Zea1and white rabbits were se1ected for short-term subcutaneous imp1ant tests in vivo. Histo1ogica1 sections were app1ied to ana1yze the thickness and inf1ammatory degree of the fiber capsu1es. Results MTT showed there were significant difference between positive contro1 group and different concentration groups except the Day 1 group,（P 〈 0. 01）. There were significant difference in 1% degradation 1iquid between Day 5 group and Day 7 group（P 〈0. 05）. Acute hemo1ytic experiment showed hemo1ysis rate of L/ DL-po1y 1actic acid materia1 was 2. 65% ,which proved good biocom-patibi1ity. Short term buria1 experiment showed there were no significant difference in inf1ammatory ce11s and tissue reaction degree be-tween L/ DL-po1y 1actic acid materia1 group and pure titanium group after imp1antation（P 〉 0. 05）,and were significant1y 1ower than pure 1ead group（P 〈 0. 05）. Conclusion L/ DL- po1y 1actic acid materia1 had good ce11 compatibi1ity and biocompatibi1ity,and it was a kind of idea1 biomedica1 materia1.