Sensitization test of magnalium at the maximal dosage / 中国组织工程研究

ABSTRACT

BACKGROUND: Magnalium which is potential to be the medical biodegraded metal implant is more and more interesting,but it must be well biocompatibility to human body.OBJECTIVE: To evaluate the sensitization of magnalium (AZ31B).METHODS: A total of 35 guinea pigs were randomly divided into saline group (negative control group,n=10),5% volume of formaldehyde (positive control group,n=10),and AZ31B group (n=15).Sensitization test at the maximal dosage was performed according to "Biological evaluation of medical devices-Part 10 Tests for irritation and delayed-type hypersensitivity",including intracutaneous induction,local induction,and provocation.Patch was removed after 6,24,48,and 72 hours,and the skin response was classified accordingto Magnusson and Kligman criteria.Patch was removed after 72 hours,and skin was performed with biopsy,stained with FIE staining,and observed under optic microscope.RESULTS AND CONCLUSION: Sensitization response was not tested in both negative control group and AZ31B group at 24,48,and 72 hours after patch removal; however,moderate erythema was observed in the positive control group.Optic microscope demonstrated that criteria of allergy such as spongiosis,edema,and diffuse as well as perivascular mononuclear infiltration was not observed in the AZ31B group,but a few basophilic calls ware observed.This suggested that AZ31B was biologically safe for sensitization.