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[Biosafety evaluation of collagen-based bone repairing material].

To evaluate the biological safety of collagen-based bone repairing material, we implanted the sample or reference substance into rats, and observed relative signs, including the specific inspection targets in animals, blood examination, analysis of immune organ, the pathological examination of organs and tissues, NK cell killing activity assay, lymphocyte group analysis, serum IL-1, IL-6, TNF-alpha detection, detection of immune globulin. Meanwhile, we set control group, sham group, and immunosuppression group. The final results showed that there was no abnormal mental state before and after the experiment. Compared with the control group, the tested group indicated no significant difference in blood test, immune organ analysis, the pathological examination of organs and tissues, NK cell killing activity assay, lymphocyte subset analysis serum IL-1, IL-6, TNF-alphadetection, and detection of immune globulin. Collagen-based bone repairing material produced a slight and transient stimulation on the rats, but created no significant inflammatory responses.