阿仑膦酸钠／磷酸钙骨水泥释放体系结构及体外释放规律的研究

Physicochemical properties and drug release profile of alendronate/calcium phosphate cement asdrug delivery system

目的制备不同浓度的阿仑膦酸钠／磷酸钙骨水泥释放体系，观察阿仑膦酸钠对磷酸钙骨水泥结构的影响及复合释放体系体外释放的规律。方法分别制备1wt％、3wt％和5wt％的载阿仑膦酸钠磷酸钙骨水泥释放体系，分别采用傅氏转换红外线光谱分析仪、扫描电子显微镜和高效液相色谱仪研究载阿仑膦酸钠磷酸钙骨水泥的结构和药物体外释放规律。结果阿仑膦酸钠的载人没有改变磷酸钙骨水泥相成分的官能团；扫描电镜下各实验组微观结构相似，均呈珊瑚样状结晶体相互交织成网状结构；各组药物在同一时间点释放量（％）的差异无统计学意义（P〉0．05），各组药物的释放均分为48h前的突释阶段和48h后的缓释阶段，符合Higuchi机制扩散释放模型。结论阿仑膦酸钠的载入对磷酸钙骨水泥的晶体结构基本没有影响，且在磷酸钙骨水泥释放体系中能够持续、稳定的释放。

Objective Preparation of alendronate （ALN）/calcium phosphate cement （CPC） as drug delivery system of different concentrations. To observe how ALN affects CPC in the crystal structure and review vitro release regularity of compound delivery system. Methods Preparation of CPC as drug delivery system loaded with alendronate in lwt%, 3wt% and 5wt%. To study the Physicochemieal properties and drug release profile of CPC loaded with alendronate by Fourier transform infrared spectroscopy, scan- ning electron rhieroscopy and high performance liquid chromatography. Results Loaded drugs do not change functional groups in calcium phosphate cements. All the groups have same mierostructure in a net- work inter-woven by coral-like shaped crystals. There is no obvious statistical significance at the same time point about the drug＇ s release quantities （ % ） （ P 〉 0. 05 ） ; Drug release has two phases-burst release （before 48h） and sustained release （after 48h）, which complies with Higuchi system. Conduslon The loading of alendronate can not affect the crystal structure of calcium phosphate cements, which still releases in sustained and steady way.