Absorbable materials bio-safety evaluation of CPP.docVIP

 PAGE \* MERGEFORMAT 3 Absorbable materials bio-safety evaluation of CPP Author: Yang Tuan China, Qing-Hua Zhang, Xue Jinshan, HE Zeng-liang, Li, JIAO Ning, Zhang [Keywords:] calcium polyphosphate fiber; absorbable implants; toxicology; Security Biological security evaluation of an absorbable CPP material [Abstract] AIM: To evaluate the biological security of a new kind of absorbable CPP material used for internal fixation of fracture. METHODS: Maximal tolerant dose of CPP was determined by intraperitoneal (ip) injection of its extractives to mice, and micronucleus test of bone marrow cells, spermatic aberration test, chromosomal aberration test, and teratogenic test were done by ip injection of maximal tolerant dose of CPP to evaluate its biological security. CPP intramuscular implantation was performed to observe its surrounding tissue reaction and evaluate its biological compatibility. RESULTS : Maximal tolerant dose of CPP extractives was above 40 mL / kg, and this dose did not have any obvious effects on micronucleus rate of bone marrow cells (1.36 ± 0.27) ‰ , chromosomal aberration rate (1.94 ± 0.46)%, spermatic aberration rate (1.51 ± 0.37)% and teratogenic rate (1.84 ± 0.55)% when compared with controls. CPP intramuscular implantation also did not cause obvious surrounding tissue inflammatory reaction. CONCLUSION: CPP is a new safe medical material with good tissue compatibility. [Keywords] calcium polyphosphate fibers; absorbable implants; toxicology; security [Abstract] Objective: To evaluate the CPP materials, bio-security. Methods: The calcium polyphosphate (CPP) material extracted fluid by intraperitoneal injection (IP) the maximum allowable dose to maximum tolerated dose of the material measured, and with the IP maximum tolerance was carried out in mice bone marrow micronucleus test, sperm aberration test, mouse bone marrow cell chromosome aberration test, teratogenic experiment toxicology tests to evaluate their safety; the same time em