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

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.