T/CSBM 0024-2022 Active

Main Technical Content: 1. Technical Requirements 1.1 Appearance: White particles or powder with no visible impurities. 1.2 Chemical Composition: The composition of sol-gel bioactive glass should primarily consist of a SiO2–P2O5–CaO ternary system, with a SiO2 content of 45 wt% to 86 wt%, a P2O5 content of 0 wt% to 10 wt%, and a CaO content of 5 wt% to 33 wt%. Minor additions of elements such as B, Na, Mg, Sr, Cu, and F may be made to improve the material's physical, chemical, and biological properties, with these elements not exceeding 5 wt% of the total composition. 1.3 XRD Analysis: The XRD pattern should primarily show diffuse peaks in the range of 20° to 35° with broad peak widths, characteristic of inorganic amorphous materials. 1.4 Specific Surface Area: The specific surface area of sol-gel bioactive glass should be measured using the BET method and fall within the range of 50 m2/g to 300 m2/g. 1.5 FTIR Analysis: In the FTIR spectrum, absorption peaks characteristic of Si–O–Si bending vibrations should appear at 540 cm–1 to 440 cm–1, Si–O–Si (tetrahedron) vibrations at 1175 cm–1 to 710 cm–1, and Si–O asymmetric stretching vibrations at 1100 cm–1 to 1000 cm–1. 1.6 Heavy Metal Content Limits: The heavy metal content should comply with the limits specified in Table 1. Table 1: Heavy Metal Content Limits Item Indicators Arsenic (As), μg/g ≤ 3 Cadmium (Cd), μg/g ≤ 5 Mercury (Hg), μg/g ≤ 5 Lead (Pb), μg/g ≤ 30 Total Heavy Metal Content (calculated as Pb), μg/g ≤ 50 1.7 Bioactivity In Vitro Mineralization Experiment: After immersing the material in Tris-HCl buffer or simulated body fluid at 37°C for 48 hours, HCA should form on the surface of the material. With increasing immersion time, the amount of HCA formed on the surface gradually increases. When the bioactive glass is immersed in the in vitro mineralization solution for a certain period of time, the FTIR spectrum of the material sample will undergo certain changes, wi