Chinese Journal of Tissue Engineering Research ›› 2010, Vol. 14 ›› Issue (16): 2899-2902.doi: 10.3969/j.issn.1673-8225.2010.16.013

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Sensitization test of magnalium at the maximal dosage

Chen Xu-qiong1, Yin Qing-shui1, Zhang Yu1, Xia Hong1, Zhang Tao1, Yang Ke2, Zhang Bing-chun2, Tan Li-li2, Lin Shan1   

  1. 1 Department of Orthopaedics, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA, Guangzhou   510010, Guangdong Province, China; 2 Institute of Metal Research, Chinese Academy of Sciences, Shenyang   110016, Liaoning Province, China
  • Online:2010-04-16 Published:2010-04-16
  • Contact: Yin Qing-shui, Professor, Chief physician, Doctoral supervisor, Department of Orthopaedics, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA, Guangzhou 510010, Guangdong Province, China gz_yqs@126.com
  • About author:Chen Xu-qiong☆, Studying for doctorate, Attending physician, Department of Orthopaedics, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA, Guangzhou 510010, Guangdong Province, China cxq_gk@126.com
  • Supported by:

    the National Natural Science Foundation of China, No. 30872642*

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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 according to Magnusson and Kligman criteria. Patch was removed after 72 hours, and skin was performed with biopsy, stained with HE 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 cells were observed. This suggested that AZ31B was biologically safe for sensitization.

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