Nanosilver Subchronic Toxicity and Silver Distribution in Different Rat Tissues
摘要
BACKGROUND: It has been reported that nanosilver-containing biomaterials produce bad biological effects after they directly contact with or are implanted into human body. OBJECTIVE: To investigate whether nanosilver yields potential adverse biological effects on human body and to evaluate its biological safety. DESIGN, TIME AND SETTING: An animal experiment observation was performed at the Medical Device Center of National Institute for the Control of Pharmaceutical and Biological Products from June 2005 to August 2006. MATERIALS: Nanosilver particles and microsilver particles were purchased from Sigma Company, USA. METHODS: Thirty rats were randomly divided into 3 groups, with 5 male and 5 female rats per group: nanosilver, microsilver, and blank control. Nanosilver and microsilver particles were respectively and subcutaneously implanted for subchronic toxicity test. The nanosilver and microsilver groups were given 0.33 g/kg nanosilver and microsilver, respectively. Rats from the blank control group received identical procedure, with the exception of drug application. Four rats were selected from each group for determination of silver content in serum and some organs by plasma mass spectrometry. MAIN OUTCOME MEASURES: serum biochemical indices, organ coefficient, and silver content. RESULTS: There was significant difference in individual organ coefficient between each drug application group and blank control group. But no significant difference in absolute mass was found between each drug application and the blank control group. These findings suggested no clinical significance of organ coefficient. Other organ coefficients were in the normal range, and there was no significant difference between each drug application group and the blank control group. Patho-histological changes related to toxicity were not found. Rats from the nanosilver group did not show toxic reaction. CONCLUSION: Nanosilver produces potential adverse biological effects after implanted i