新型可降解磷酸镁骨水泥的热原实验  

Pyrogen test about novel biodegradable magnesium phosphate cement

作　　者：韩振川 刘洋[2] 熊森[1] 张雅宾[1] 李修璨 王旭翾[1] 毛克亚[1] 

机构地区：[1]解放军总医院骨科,北京100853 [2]解放军总医院肿瘤中心实验室,北京100853

出　　处：《解放军医学院学报》2016年第5期483-485,共3页Academic Journal of Chinese PLA Medical School

基　　金：国家自然科学基金项目(51372276)~~

摘　　要：目的通过动物热原实验探讨磷酸镁骨水泥(magnesium phosphate cement,MPC)的生物安全性,补充磷酸镁骨水泥生物相容性的证据,为其在骨科临床领域应用提供依据。方法选取健康新西兰白兔20只,分为MPC实验组(A组)和对照组(B组),每组各10只。制备MPC浸提液,将浸提液预热至38℃,按照10 ml/kg将浸提液通过耳缘静脉注入实验组(A组)兔体内;同样方法,将预热至38℃的0.9%氯化钠注射液注入对照组(B组)兔体内;输注速度为2 ml/min。输注前及给药后每隔0.5 h测量体温,共测量6次。结果实验组(A组)及对照组(B组)兔体质量(kg)、输注液体量(ml)、初始体温(℃)差异无统计学意义(P>0.05);实验组(A组)在输注浸提液0.5 h、1 h、1.5 h、2 h、2.5 h、3 h测得体温与对照组(B组)相应时刻测得的体温差异无统计学意义(P>0.05);实验组(A组)在输注浸提液后测得的最高体温与对照组(B组)测得的最高体温差异无统计学意义(P>0.05);实验组(A组)及对照组(B组)测得的最高体温与初始体温差异均无统计学意义(P>0.05)。结论 MPC置入动物体内不发生热原反应,初步证明其热原检测安全可靠。Objective To investigate the biological safety of magnesium phosphate cement（MPC） by pyrogen test and add evidences in biocompatibility of MPC for its application in clinical orthopaedics. Methods Twenty New Zealand white rabbits were randomly divided into MPC group（group A） and control group（group B）, ten rabbits in each group. MPC leaching solution was prepared and preheated to 38℃, and then it was injected into the rabbits of group A through ear vein with volume of 10 ml/kg. 0.9% sodium chloride injection was preheated to 38℃ and was injected into rabbits of group B by the same way with injection speed of 2 ml/min. The temperature of every rabbit was recorded before injection, and the body temperature was measured every 0.5 h after injection, for total six times. Results There was no statistical difference in body weight（kg）, injection volume（ml）, initial body temperature（℃） between MPC group and control group（P〉0.05）. After injection leaching solution at time points of 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, no statistical difference was found in the body temperature between MPC group and control group（P〉0.05）. There was no statistical difference in maximum temperature between MPC group and control group after injection（P〉0.05）, and no statistical difference was found between maximum temperature and initial temperature in MPC group and control group（P〉0.05）. Conclusion There is no pyrogen reaction in animals after being injected with MPC, and the preliminary results show that MPC is safe and can be applicated in orthopaedics.

关 键 词：生物相容性 磷酸镁骨水泥 热原试验 可降解材料 

分 类 号：R687.3[医药卫生—骨科学]