新型可吸收骨蜡的临床前动物实验研究  

Preclinical animal experimental study of a new absorbable bone wax

作　　者：杨柳 张雨 吴亚东 陈丹丹[1] 付海洋[1] Yang Liu;Zhang Yu;Wu Yadong;Chen Dandan;Fu Haiyang(National Institutes for Food and Drug Control,Beijing,102629;Beijing Maidi Siwei Biotechnology Co.,Ltd.,Beijing,100176,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]北京迈迪思维生物技术有限公司,北京100176

出　　处：《生物骨科材料与临床研究》2023年第5期7-12,共6页Orthopaedic Biomechanics Materials and Clinical Study

摘　　要：目的通过动物实验了解新型可吸收骨蜡的降解周期,并研究可吸收骨蜡与骨组织的生物相容性。方法采用18只试验羊进行骨植入试验。每只羊的6节胸骨分别作为独立的植入位点,随机选择各2个位点分别使用实验品可吸收骨蜡(实验组)或对照品强生骨蜡(对照组)止血,剩余2个位点作为空白(空白组)。术后2、6、12周各随机处死6只试验羊,取胸骨进行HE切片,进行组织学评价和材料降解情况分析。采用20只小鼠分别通过尾静脉注射和腹腔注射样品浸提液和对照观察小鼠的毒性症状。采用6只兔子通过皮内注射样品浸提液和对照观察各注射部位的红斑和水肿的组织反应。结果实验组与空白组相比,实验品植入胸骨损伤表面2、6、12周,显示为无刺激;对照组与实验组相比,植入6、12周,显示为中度刺激。与对照品相比,实验品的组织学反应更加轻微。可吸收骨蜡降解过程中未见纤维组织包囊,新骨生长明显,至12周时,可吸收骨蜡基本降解完全,新骨连接两断端,骨损伤已得到修复。在急性毒性实验中,各组小鼠体重均稳步增长;在刺激试验中,可吸收骨蜡生理盐水的积分为0,玉米油的积分均为0.11。结论新型可吸收骨蜡至植入12周时,已基本降解完全。该新型可吸收骨蜡是一种安全、无毒性、可用于骨创面止血的材料。Objective To understand the degradation cycle of new absorbable bone wax by animal experiments,and to study the biocompatibility between absorbable bone wax and bone tissue.Methods The bone implantation test was performed on 18 experimental sheep.The six sternums of each sheep were used as independent implantation sites.Two sites were randomly selected for hemostasis with the experimental product absorbable bone wax(experimental group)or the control product Johnson&Johnson bone wax(control group),and the remaining two sites were used as blank(blank group).Six experimental sheep were randomly killed at 2,6,and 12 weeks after operation.The sternum was collected for HE sections for histologic evaluation and material degradation analysis.Toxic symptoms of 20 mice were observed by tail vein injection and intraperitoneal injection of sample extract and control.Six rabbits were used to observe the tissue reaction of erythema and edema at each injection site through intradermal injection of sample extract and control.Results Compared with the blank group,the experimental object was implanted on the sternal injury surface for 2,6 and 12 weeks and showed no stimulation.Compared with the experimental group,the control group showed moderate stimulation after implantation for 6 and 12 weeks.The histologic response of the test device was less than that of the control.No fibrous tissue capsule was found during the degradation of absorbable bone wax,and the new bone grew obviously.At 12 weeks,the sample was basically degraded completely,the two broken ends of the new bone were connected,and the bone injury was repaired.In the acute toxicity test,the weight of the mice in each group increased steadily.In the stimulation test,the integral of the physiological saline of the sample was 0,and the score of corn oil was 0.11.Conclusion After 12 weeks,the absorbable bone wax can be completely absorbed by the bone.It is a safe,non-toxic,and hemostatic material for bone wound.

关 键 词：可吸收骨蜡:植入 降解 动物实验 

分 类 号：R318.08[医药卫生—生物医学工程]