PLGA/HA支架材料生物相容性的动物实验研究

目的:通过动物实验评价新型多孔聚乳酸乙醇酸/羟基磷灰石(polyaiticglycolic acid/hydroxyapatite,PLGA/HA)支架材料的生物相容性。方法:分别将5%和10%HA掺量的PLGA/HA支架材料注射到昆明小鼠腹腔内、植入到新西兰大白兔体内,选择全身毒性试验、亚急性毒性试验、血液相容性试验、肌肉刺激试验等,对其生物相容性进行评价。结果:全身急慢性毒性试验显示材料种植到小鼠及兔子体内后,动物一般情况良好,2周后体重、红细胞计数、白细胞计数等生理参数未见明显变化;实验显示两种材料对兔混合血浆凝血功能无影响;溶血试验结果显示5%和10%的PLGA/HA的溶血率分别为2.67%和3.62%,均小于5%,完全符合医用材料对溶血试验的要求;肌肉刺激试验结果显示两种材料埋植后局部未见红肿,4周时部分PLGA/HA材料开始降解,降解部分有大量的纤维结缔组织生长;HE染色结果显示PLGA/HA基本不存在抗原性,植入机体4周后,材料周围未见明显炎症细胞浸润。结论:5%和10%HA掺量的PLGA/HA均具有良好的生物相容性和体内安全性。

Study on Bio-compatibility of PLGA/HA in vivo

Objective: To evaluate biological compatibility of a new porous polyaiticglycolic acid/hydroxyapatite(PLGA/HA) scaffold in animal experiment. Methods: PLGA/HA scaffold (with 5% HA or 10% HA) were injected into Kunming mice intraperitoneally and implanted into New Zealand rabbits. The biocompatibility experiments included systemic toxicity test, sub-acute toxicity test, blood compatibility test, and muscle stimulation test. Results: After injection and implantation of PLGA/HA scaffold into mice and rabbits, general condition of animals remained normal.Weight, red blood cell count, and white blood cell count of experimental animals altered slightly. Rabbit mixed plasma coagulation function wasn't affected. Hemolytic rate of PLGA/HA scaffold with 5% HA or 10% HA were 2.67% and 3.62% respectively, which met the requirement of hemolysis test standard (<5%)as a medical material. Muscle stimulation test revealed that implantation did not cause any local redness. Part of PLGA/HA scaffold started to degrade at 4th week. There were little inflammatory cell infiltrations around the material 4 weeks after implantation. Conclusion: Both PLGA/HA scaffold with 5% HA or 10% HA have good biocompatibility.