丹红注射液-磷酸钙骨水泥释放体系的力学性能、显微结构及体外释放  

Mechanical property,microstructure and in vitro release of Danhong injection-calcium acid phosphate bone cement

作　　者：任鹏宇[1] 刘娟[2] 刘彦宁[1] 刘淼[1] 

机构地区：[1]西安交通大学医学院第一附属医院骨科,陕西省西安市710061 [2]西安交通大学医学院第一附属医院药剂科,陕西省西安市710061

出　　处：《中国组织工程研究与临床康复》2009年第3期487-492,共6页Journal of Clinical Rehabilitative Tissue Engineering Research

摘　　要：背景:研究证实磷酸钙骨水泥与药物混合后可能会影响磷酸钙骨水泥的固化反应过程和晶体形成过程,进而改变反应终产物的晶体结构和生物力学强度等性能。目的:制备不同浓度丹红注射液-磷酸钙骨水泥释放体系,观察丹红注射液对磷酸钙骨水泥生物力学强度、晶体结构形态的影响以及复合释放体系体外释放的特点。设计、时间及地点:对比观察实验,于2008-02在西安交通大学生物医学实验中心完成。材料:制备0.5倍、1倍、2倍市售浓度的丹红注射液,并与磷酸钙骨水泥复合形成释放体系。方法:载药磷酸钙骨水泥在模具中固化完全后,利用万能测试机检测其力学强度,扫描电镜观测晶体结构形态。以原儿茶醛为检测标志物,高效液相色谱法测定312nm处物质浓度,以了解体外释放情况。主要观察指标:①空白以及载药磷酸钙骨水泥微观结构的观察。②空白以及载药磷酸钙骨水泥生物力学强度的测定。③载药磷酸钙骨水泥体外释放药物浓度的测定。结果:丹红注射液可使磷酸钙骨水泥力学强度下降,2倍浓度组最为显著(P<0.05);丹红注射液与磷酸钙骨水泥复合未改变磷酸钙骨水泥微观晶体结构形态;释放体系在释放初期存在突释效应,约36h后释放浓度趋于平稳。结论:较大剂量丹红注射液与磷酸钙骨水泥复合可显著降低磷酸钙骨水泥力学强度;丹红注射液对磷酸钙骨水泥晶体结构形态无影响;磷酸钙骨水泥是丹红注射液较稳定的缓释载体。BACKGROUND： The mixture of calcium acid phosphate bone cement and drugs can affect curing reaction and crystallization of calcium acid phosphate bone cement, which can finally change crystal structure and biomechanics strength of end products. OBJECTIVE： To prepare various concentrations of Danhong injection-calcium acid phosphate bone cement release system, to observe effects of Danhong injection on biomechanics strength and crystal structure morphology of calcium acid phosphate bone cement, as well as on the release characteristics of compound release system in vitro. DESIGN, TIME AND SETTING： The controlled, observation experiment was conducted at the Biomedicine Experimental Center, Xi＇an Jiaotong University in February 2008. MATERIALS： 0.5-fold, 1-fold and 2-fold Danhong injection was incorporated into calcium acid phosphate bone cement and formed the release system, respectively. METHODS： Following complete solidification of drug-loaded calcium acid phosphate bone cement in the tooting, mechanics strength was detected using an omnipotent testing. Crystal structure morphology was observed with a scanning electron microscope. The in vitro release of the resultant products was studied by evaluating the marker of protocatechualdehyde at 312 nm using high efficiency liquid chromatography. MAIN OUTCOME MEASURES： The crystal structure of incorporated and untreated calcium acid phosphate bone cement was observed. Biomechanics strength of incorporated and untreated calcium acid phosphate bone cement was determined. In vitro release of incorporated calcium acid phosphate bone cement was determined. RESULTS： Compared with control group, the maximum compression strength was significantly decreased when 2-fold Danhong injection was incorporated into calcium acid phosphate bone cement （P 〈 0.05）. No significant changes in the crystal structure after incorporation of the Danhong injection. Release system existed burst effects during early release phase. Release concentration was stable after 36 hours

关 键 词：磷酸钙骨水泥 丹红注射液 理化性质 体外释放 

分 类 号：R318[医药卫生—生物医学工程]