可注射磷酸镁骨水泥的制备新技术及其水化硬化机制研究

This project aims at developing a novel approach for the fabrication of injectable magnesium phosphate bone cements. Firstly, induction plasma spheroidizing technology is adopted to fabricate spherical MgO powders with controlled morphology, particle size and degree of crystallization. By adjusting the reaction activity of the solid-liquid interface, the effects of the ingredients and the processing factors on the characteristics of the setting reaction, phase composition and microstructure, as well as the physiochemical and biological performance of the products is to be investigated systematically. The mechanism for the setting reaction of MPC is to be clarified and the reaction kinetics formula is to be derived. Based on the achieved MPC with controlled microstructure and performance, the injectability, biocompatibility, osteogenic activity and biodegradability of MPC is to be investigated systematically. The repairing effect for the bone fracture and bone defects，especially for the comminuted facture and osteoporotic fracture, is to be characterized and evaluated by living animal experiments, which is to be applied to conduct the MPC fabrication, consequently, the MPC with excellent injectability and excellent repairing effect is expected. With this investigation, a novel approach for fabricating MPCs with controlled microstructure and preformance will be developed, which can build up a new route for design and fabrication of new bone repair materials and basic data for clinical application,evaluation and improvement of the bone repair materials in different application.

本项目旨在研究一种可注射的磷酸镁基骨水泥（MPC）的新型制备技术。首先采用感应等离子球化技术制备出粒度及结晶度可控的MgO球形粉，进而从调控固/液界面反应活性入手，系统研究反应剂组分及工艺参数对MPC合成过程特征以及产物的组分、微观结构、理化性能和生物学性能的影响规律，建立MPC水化硬化过程机制及MPC反应合成过程动力学；在实现MPC结构、性能可控的基础上，系统研究MPC的可注射性、生物相容性、成骨活性和降解特征；特别考察MPC修复粉碎性骨折和骨质疏松性骨折的效果，通过活体动物模型对其骨缺损修复效果的表征和评价，反馈指导MPC的制备工艺，从而获得具有优良可注射性能和骨修复效果的MPC。 通过课题研究，研制出一种结构性能可控的MPC骨水泥的制备新技术，从而为新型骨修复材料的设计、制备开辟一条新途径，并为骨修复材料的临床筛选、评价和改进提供材料样本和基础科学数据。

本课题探索了一种可注射的磷酸镁骨水泥（MPC）的新型制备技术，并探讨了其理化、生物学性能。采用感应等离子球化技术制备出粒度及结晶度可控的MgO球形粉，进而从调控液界面反应活性入手，系统研究反应剂组分及工艺参数对MPC合成过程特征以及产物的组分、微观结构、理化性能的影响规律，建立MPC水化硬化过程机制及MPC反应合成过程动力学。在实现MPC结构、性能可控的基础上，系统研究MPC的可注射性、生物相容性。体外骨折粘合试验证实MPC具有良好的粘合特性。在动物实验中，MPC修复股骨髁骨缺损表现出良好的成骨效应。腰椎融合试验证实MPC椎间融合器在术后6月可实现腰椎融合，进一步证实其成骨性。与此同时，在体内实验中，MPC也表现出良好的可降解性能。综上，本课题研制出了一种结构性能可控的MPC骨水泥制备新技术，通过体外、体内试验，证实可注射的MPC理化、生物性能良好。本课题为骨修复材料的设计、制备开辟了一条新途径，并为骨修复材料的临床筛选、评价和改进提供材料样本和基础科学数据。