In vitro and in vivo assessment of the biocompatibility of an Mg-6Z(n) alloy in the bile.

There is a great clinical need for biodegradable bile duct stents. Biodegradable stents made of an Mg-6Zn alloy were investigated in both vivo animal experiment and in vitro cell experiments. During the in vivo experiments, blood biochemical tests were performed to determine serum magnesium, serum creatinine (CREA), blood urea nitro-gen (BUN), serum lipase (LPS), total bilirubin (TB) and glutamic-pyruvic transaminase (GPT) levels. Moreover, tissue samples of common bile duct (CBD), liver and kidney were taken for histological evaluation. In the in vitro experiments, primary mouse extrahepatic bile duct epithelial cells (MEBDECs) were isolated and cultured. Cytotoxicity testing was carried out using the MTT method. Flow cytometry analyses with propidium iodide staining were performed to evaluate the effect of Mg-6Zn alloy extracts on cell cycle. The in vivo experiments revealed no significant differences (P > 0.05) in serum magnesium, CREA, BUN, LPS, TB or GPT before and after the operation. Based on the HE results, hepatocytes, bile duct epithelial cells, renal glomerulus and renal tubule tissues did not present significant necrosis. In the in vitro experiments, the cell relative growth rate curve did not change significantly from 20 to 40 % extracts. In vitro experiments showed that 20-40 % Mg-6Zn extracts are bio-safe for MEBDECs. In vivo experiments showed that Mg-6Zn stents did not affect several important bio-chemical parameters or, harm the function or morphology of the CBD, kidney, pancreas and liver. Our data suggested that this Mg-6Zn alloy is a safe biocompatible material for CBD.