本研究旨在開發一可注射磷酸鈣骨水泥,直接以注射裝置注入局部並快速固化,可作為藥物緩釋載體輔助治療,載生長因子促進新骨的形成並改善骨結合性能,以四鈣磷酸鹽(TTCP)及無水磷酸氫鈣(DCPA)為主成分設計配方,並添加氫氧基磷灰石(HAp)作為晶種,以加快轉化速率,及添加無水檸檬酸(CA),可縮短骨水泥的固化時間,提高抗壓強度,之後將不同比例的甲基纖維素(MC)及聚乙烯吡咯烷酮(PVP)黏合劑添加入磷酸鈣骨水泥內,改善磷酸鈣骨水泥的注射性能,再以磷酸氫二鈉溶液作為結合劑製成複合材料。 實驗結果顯示,添加甲基纖維素(MC)及聚乙烯吡咯烷酮(PVP)黏合劑,做基本物理性質、生物相容性測試及藥物制放實驗,顯示注射性不受MC黏合劑及PVP黏合劑含量增加而降低,但MC愈多,需要愈多硬化液才能形成麵團狀。破裂強度會隨著MC黏合劑之含量增加而降低,MC比例對硬化時間無顯著影響。反之PVP黏合劑添加,破裂強度會隨著PVP黏合劑之含量增加而增加。而PVP黏合劑5%以上,對破裂強度影響就不明顯。添加黏合劑之複合材料於浸泡實驗後,藉由觀察試片表面的顯微結構,可看到試片表面會形成氫氧基磷灰石(HAp),細胞毒性測試則呈現材料無毒。藥物制放顯示材料在浸泡24小時內,藥物制放率上升至10 %;而隨著浸泡時間的增長,後續釋放情況呈現穩定緩慢上升狀態,由此可見,材料適合作為藥物之載體。
This study aims to develop an injectable calcium phosphate bone cement injection device directly injected locally and fast curing, can be used as drug delivery adjuvant therapy containing growth factors promote the formation of new bone and improve bone bonding properties to Tetracalcium phosphate (TTCP) and Dicalcium phosphate (DCPA) as a main component formulation design and add hydroxyapatite (HAp) as a seed to accelerate the rate of conversion of anhydrous citric acid, and (CA), the bone can be shortened cement curing time, increase strength, after adding different proportions of methyl cellulose (MC) and polyvinylpyrrolidone (PVP) into calcium phosphate cement binder within, to improve the performance of calcium phosphate bone cement injection, then disodium hydrogen phosphate solution as a binding agent made of composite material. Experimental results show that adding methyl cellulose (MC) and polyvinylpyrrolidone (PVP) adhesives, do basic physical properties, biocompatibility testing and drug controlled release experiments, showing the injection of PVP from MC adhesives and adhesives content increased and decreased, but the MC more, need the more hardened liquid to form a dough-like. Rupture strength increases with the decrease binder content MC, MC no significant effect on the proportion of curing time. Conversely PVP binder added, rupture strength increases with increasing content of PVP binder. And more than 5% PVP binder, bursting strength affect not obvious. Add adhesives for composite materials after immersion test, by observing the microstructure of the specimen surface, you can see the specimen surface will form hydroxyapatite (HAp), cytotoxicity tests are showing toxic materials. Controlled drug delivery system to display material within 24 hours soaking, drug controlled release rate rose to 10 percent; With the increase of immersion time, the subsequent release of the case show a slow rise in the steady state, we can see that the material is suitable as a drug carrier.