| Objective To explore the impact of hydroxyapatite (HA) coating on the biosafety of 3D printing titanium alloy materials. Methods 3D printing titanium alloy materials were divided into two sample groups: HA coated materials and non-HA coated materials. Cytotoxicity, irritation, acute toxicity, hemolysis, reverse mutation, mouse lymphoma test and cell carcinogenesis test were carried out respectively. The biosafety evaluation of the two materials was compared to observe the effect of hydroxyapatite (HA) coating on the biosafety of 3D printed titanium alloy acetabular cup material. Results In the cytotoxicity test, the cell survival rate of the HA coated group was (117±6)%, and the cell survival rate of the non-HA coated group was (106±14)%, both of which were greater than 75%; in the stimulation test, the integral of the physiological saline of the two materials were 0, the integral of corn oil of the two materials were 0.06; in the acute toxicity, the weight of the mice in each group increased steadily; in the hemolysis test, the hemolysis rate of the HA coated material was 0.125%, and the hemolysis rate of the non-HA coated group was -0.257%; in the Ames test, the numbers of back-mutated colonies of the two materials were within the normal range; in the mouse lymphoma test, the mutation frequency MF of each dose group was greater than or less than that of the negative control group, and the slightly dose higher than the negative control group did not exceed 126×10-6. Conclusion The experiment results proved that the two materials do not have cytotoxicity, acute toxicity, irritation and genetic toxicity, and also proved that the two materials do not have hemolytic effect. Both HA coated materials and non-HA coated materials showed good biological safety, which proves that HA coated materials are safe and reliable, and it also provides a way for future titaniumalloymaterials to bemodified by adding coatings safety basis. |
