骨局部植入型硫酸钙/聚乳酸/庆大霉素释放系统的生物相容性研究

Biocompatibility of bone-implanted calcium sulfate/polylactic acid/getamycin delivery system

  • 摘要: 目的 以柠檬酸化硫酸钙和聚乳酸的复合物作为抗生素载药基质,构建骨植入型硫酸钙/聚乳酸/庆大霉素药物释放系统,对其生物相容性进行研究。方法 根据医疗器械生物学评价实验选择指南对药物释放系统进行红细胞溶血实验、细胞毒性实验、热原实验、肌肉内植入实验等生物相容性评价。结果 抗生素释放系统红细胞溶血率为3.07%,小于阳性标准;细胞毒性实验中实验组细胞相对增殖率和对照组无统计学差异,毒性评分为0~1级;兔平均体温升高为0.3℃;抗生素释放系统在肌肉组织内可逐渐降解,材料周围未见大量炎性细胞浸润,组织无排斥。结论 抗生素释放系统无溶血作用,无细胞毒性,符合医用材料的热原反应要求,具有良好的生物相容性和安全性,符合医用生物材料的基本要求。

     

    Abstract: Objective To develop the bone-implanted calcium sulfate/polylactic acid/gentamycin(CaS/PLA/GM) delivery system using composite of citrated calcium sulfate and polylactic acid as an antibiotic delivery matrix and to evaluate its biocompatibility. Methods CaS/PLA/GM implant tablets were made from composite of citrated calcium sulfate and polylactic acid mixed with gentamycin at a certain ratio. According to ISO 10993-1 standards,following biological experiments were performed to evaluate the biocompatibility and safety of the CaS/PLA/GM delivery system,as well as haemolysis,cytotoxicity,pyrogenic,and intramuscular implanting tests. Results The haemolysis rate was 3.07%,which was lower than the positive standard for haemolysis. The drug delivery system had no toxicity to mesenchymal cell proliferation. The body temperature had no significant changes in pyrogenic test. The drug delivery system could be absorbed when it was implanted in muscles,and no significant inflammatory response was observed in the surrounding tissue. Conclusion The CaS/PLA/GM system is biocompatible and safe. It can meet the demands of medical biomaterials.

     

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