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目的制备一种高纯医用硫酸钙(CaSO_4)并分析其生物相容性。方法尝试通过化学试剂反应合成的方法辅以多级洁净工艺,实现高纯度植入级CaSO_4材料的合成,用X射线衍射仪技术(XRD)进行晶相分析,热重-差热(TG/DTA)分析材料热转化温度,扫描电子显微镜(SEM)观察材料晶体形态,用电感耦合等离子体发射光谱仪(ICP-OES)检测所得材料的成分纯度和重金属元素含量,用体内异常毒性检测以判定材料是否符合安全性规定。结果 XRD结果显示所得材料为CaSO_4·2H_2O;该材料在150℃会失去结晶水;SEM显示CaSO_4·2H_2O形貌以棒状结构为主,宽度为7.5~10.0 um,无明显的团聚现象;ICP-OES测定其纯度为99.9%,未检测到重金属元素铅、汞、砷、镉,铁元素的含量为5.281 ppm;体内植入显示术后48 h内小鼠精神状态和进食等活动如常。结论本实验通过化学合成的方法辅以多级净化工艺制备CaSO_4,其纯度达到植入级硫酸钙规定,异常毒性检验符合生物相容性要求,可以进行后续植入硫酸钙的组织工程材料研究。
Objective To prepare a high purity medical calcium sulfate (CaSO_4) and analyze its biocompatibility. Methods Synthesis of CaSO_4 with high purity and high purity was achieved through chemical reagent reaction synthesis combined with multi-stage clean process. The crystal structure was analyzed by X-ray diffraction (XRD), TG / DTA ) Was used to analyze the thermal transition temperature of the material. The crystal morphology of the material was observed with a scanning electron microscope (SEM). The purity of the component and the contents of heavy metal elements were determined by inductively coupled plasma atomic emission spectroscopy (ICP-OES) Compliance with safety regulations Results The XRD results showed that the obtained material was CaSO 4 · 2H 2 O. The material lost its crystal water at 150 ℃. The SEM showed that the morphology of CaSO 4 · 2H 2 O was mainly rod-like, with a width of 7.5-10.0 μm and no agglomeration. ICP-OES The purity of lead, mercury, arsenic, cadmium and iron was 5.281 ppm. The in vivo implantation showed that the mental status and eating behavior of mice were normal after 48 h. Conclusions In this experiment, CaSO_4 was prepared by chemical synthesis combined with multi-stage purification process. The purity of CaSO_4 reached the requirement of implant grade calcium sulfate. The abnormal toxicity test conformed to the requirement of biocompatibility and could be used for subsequent tissue engineering materials implantation of calcium sulfate.