Objective: To study the preparation and properties of the hyaluronic acid (HA)/α-calcium sulfate hemihydrate (α-CSH)/β-tricalcium phosphate (β-TCP) material (hereinafter referred to as composite material).
Methods: Firstly, the α-CSH was prepared from calcium sulfate dihydrate by hydrothermal method, and the β-TCP was prepared by wet reaction of soluble calcium salt and phosphate. Secondly, the α-CSH and β-TCP were mixed in different proportions (10∶0, 9∶1, 8∶2, 7∶3, 5∶5, and 3∶7), and then mixed with HA solutions with concentrations of 0.1%, 0.25%, 0.5%, 1.0%, and 2.0%, respectively, at a liquid-solid ratio of 0.30 and 0.35 respectively to prepare HA/α-CSH/ β-TCP composite material. The α-CSH/β-TCP composite material prepared with α-CSH, β-TCP, and deionized water was used as the control. The composite material was analyzed by scanning electron microscope, X-ray diffraction analysis, initial/final setting time, degradation, compressive strength, dispersion, injectability, and cytotoxicity.
Results: The HA/α-CSH/β-TCP composite material was prepared successfully. The composite material has rough surface, densely packed irregular block particles and strip particles, and microporous structures, with the pore size mainly between 5 and 15 μm. When the content of β-TCP increased, the initial/final setting time of composite material increased, the degradation rate decreased, and the compressive strength showed a trend of first increasing and then weakening; there were significant differences between the composite materials with different α-CSH/β-TCP proportion ( P<0.05). Adding HA improved the injectable property of the composite material, and it showed an increasing trend with the increase of concentration ( P<0.05), but it has no obvious effect on the setting time of composite material ( P>0.05). The cytotoxicity level of HA/α-CSH/β-TCP composite material ranged from 0 to 1, without cytotoxicity.
Conclusion: The HA/α-CSH/β-TCP composite materials have good biocompatibility. Theoretically, it can meet the clinical needs of bone defect repairing, and may be a new artificial bone material with potential clinical application prospect.
目的: 探讨透明质酸（hyaluronic acid，HA）/α-半水硫酸钙（α-calcium sulfate hemihydrate，α-CSH）/β-磷酸三钙（β-tricalcium phosphate，β-TCP）复合人工骨材料（以下简称复合材料）的制备及其性能。.
方法: 采用水热法将二水硫酸钙脱水制备α-CSH，可溶性钙盐和磷酸盐反应法制备β-TCP。将α-CSH、β-TCP粉末按照不同比例（10∶0、9∶1、8∶2、7∶3、5∶5、3∶7）混合，分别与浓度为0.1%、0.25%、0.5%、1.0%、2.0%的HA溶液以及去离子水，以液固比0.30、0.35混合，制备HA/α-CSH/β-TCP、α-CSH/β-TCP复合材料。将制备样品进行扫描电镜观察、X射线衍射分析、初凝/终凝时间测定、降解测定、抗压强度测定、溃散情况观察、可注射性实验以及细胞毒性实验。.
结果: 成功制备HA/α-CSH/β-TCP复合材料。该复合材料表面粗糙，不规则片块状颗粒、条状颗粒密集堆积，表面呈微孔结构，孔径主要在5～15 μm之间。随β-TCP含量增加，复合材料初凝、终凝时间均增加，降解率降低，抗压强度呈先增加再减弱变化趋势，不同α-CSH/β-TCP比例制备材料间差异均有统计学意义（ P<0.05）；添加HA可提高复合材料可注射性，且随浓度增加呈增加趋势（ P<0.05），但对复合材料的凝固时间无明显影响（ P>0.05）。HA/α-CSH/β-TCP复合材料细胞毒性等级为0～1级，无细胞毒性。.
结论: HA/α-CSH/β-TCP复合材料具有良好生物相容性，理论上可满足临床骨缺损修复需求，是一种具有潜在临床应用前景的新型人工骨材料。.
Keywords: Artificial bone composite material; hyaluronic acid; α-calcium sulfate hemihydrate; β-tricalcium phosphate.