聚乳酸/甲壳素复合材料的制备及动物安全性评价

Preparation of polylactic acid/chitin composite material and its safety evaluation by animal experiments

目的通过聚乳酸/甲壳素的复合,制备一种具有较好生物相容性和生物可降解性的组织工程支架材料。方法采用溶液法将两种材料进行复合,待溶剂挥发后成型。对此材料进行动物实验以评价其安全性。结果过敏实验结果显示,动物对复合材料浸提液反应与阴性对照没有明显区别,除阳性对照的豚鼠外,均未出现刺激反应;热原实验结果显示,在每种材料初试的3只新西兰白兔中,体温升高均在0.2 ℃以下,并且体温升高总度数在1.0 ℃以下,符合热源实验的评价标准。全身急性毒性实验显示,兔子在注射浸提液后,没有任何不安、焦躁或其它萎靡不振等不健康行为。结论聚乳酸/甲壳素复合材料在生物学评价实验中符合评价标准,可用作组织工程支架体的基质材料。

Objective To prepare a scaffold material with good biocompatibility and biodegradability by compounding poly-lactic acid (PLA) and chitin. Methods After preparation of PLA from lactic acid, the compounding of PLA and chitin was carried out by dissolving these 2 materials in one solution for reaction. The composite material was obtained and molded after the solvent was evaporized, and the safety tests of this resultant material were conducted in guinea pigs and New Zealand rab-bits, respectively. Results In allergic test, the guinea pigs responded to the digestion solution of the composite material in al-most the same manner as to normal saline (the latter serving as negative control), and no obvious allergic reaction was ob-served in the animals except those in positive control group. Pyrogenic test by injecting the digestion solution of the composite material in 6 rabbits found a raise in the body temperature less than 0.2 ℃, with the total increase (adding up the individual temperature raise) less than 1.0 ℃, to meet the accepted criteria for the pyrogenic test. In subsequent toxicity test, the rabbits showed no signs of agitation or inanimate behavior after injection. Conclusion PLA/chitin composite material conforms to the ISO10993-1, and can be used as a basic scaffold material in tissue engineering.